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Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 28, 2020 Session on COVID-19 and Cancer 9:00 AM

Posted in Biomarkers: Inflammation, Cancer - General, Cancer and Current Therapeutics, Cancer Researchers Fighting COVID-19, Coronavirus Gene Expression, COVID-19, COVID-19: Pandemic Surgery Guidance, Economic Impact of Coronavirus Pandemic, REAL TIME Conference Coverage Twitter's Hashtags and Handles per Presentation/session, SAR-Cov-2 a vasculotropic (blood vessels) RNA Virus, SARS-CoV-2, Seasonality & Environmental Factors in Resurgence, Serology tests for coronavirus antibodies, Vaccinology, Viral diseases, Virus Infective Acute Respiratory Syndrome: SARS-CoV, tagged , , , , , , , on April 28, 2020| Leave a Comment »

Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 28, 2020 Session on COVID-19 and Cancer 9:00 AM

Reporter: Stephen J. Williams, PhD

 

COVID-19 and Cancer

Introduction

Antoni Ribas
UCLA Medical Center

  • Almost 60,000 viewed the AACR 2020 Virtual meeting for the April 27 session
  • The following speakers were the first cancer researchers treating patients at the epicenters of the pandemic even though nothing was known about the virus

 

The experience of treating patients with cancer during the COVID-19 pandemic in China
Li Zhang, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • reporting a retrospective study from three hospitals from Wuhan
  • 2.2% of Wuhan cancer patients were COVID positive; most were lung cancers and most male; 35% were stage four
  • most have hospital transmission of secondary infection; had severe events when admitted
  • 74% were prescribed antivirals like ganciclovir and others; iv IgG was given to some
  • mortailtiy rate of 26%; by April 4 54% were cured and discharged; median time of infection to severe event was 7 days; clinical presentation SARS sepsis, and shock
  • by day 10 in lung cancer patients, see lung path but after supportive therapy improved
  • cancer patients at stage four who did not receive therapy were at higher risk
  • cancer patients who had received chemo in last 14 days had higher risk of infection
  • they followed up with cancer patients on I/O inhibitors;  it seemed there was only one patient that contracted COVID19 so there may not be as much risk with immune checkpoint inhibitors

 

TERAVOLT (Thoracic cancERs international coVid 19 cOLlaboraTion): First results of a global collaboration to address the impact of COVID-19 in patients with thoracic malignancies

Marina Chiara Garassino

@marinagarassino
Fondazione IRCCS Istituto Nazionale dei Tumori

Dr Marina Chiara Garassino is the Chief of the Thoracic Oncology Unit at Istituto Nazionale dei Tumori, Milan, Italy. She leads the strategy for clinical and translational research in advanced and locally advanced NSCLC, SCLC, mesothelioma and thymic malignancies. Istituto Nazionale dei Tumori in Milan is the most important comprehensive cancer in Italy and one of the most important in Europe. As a medical oncologist, she has done research in precision medicine and in immuno-oncology. Her main research interests have been mainly development of new drugs and therapeutical strategies and biomarkers. She has contributed to over 150 peer-reviewed publications, including publications as first or last author in the New England Journal of Medicine, Lancet Oncology, Journal of Clinical Oncology, Annals of Oncology. She has delivered many presentations at international congresses,  including  AACR, ASCO, ECCO, ESMO, WCLC. Her education includes a degree and further specialization in Medical Oncology at Università degli Studi in Milan. She achieved a Master Degree in Oncology management at University of Economics “Luigi Bocconi”. She completed her training with an ESMO Clinical fellowship in 2009 at Christie’s Hospital in Manchester (UK). She was a member of the EMA SAG (Scientific Advisory Group). She is serving as ESMO Council member as the Chair of the National Societies Committee. She was the ESMO National Representative for Italy for 5 years (2011-2017). She is serving on several ESMO Committees (Public Policy extended Committee, Press Committee, Women for Oncology Committee, Lung Cancer faculty, Membership Committee).She used to be an active member of the Young Oncologist Committee. She’s serving on both ESMO, WCLC and ASCO annual congress Lung Cancer Track (2019, and 2020), Chair of ESMO National Societies, from 2019. She is the founder and president of Women for Oncology Italy.

  • 2 million confirmed cases but half of patients are asymptomatic and not tested; pooled prevalance of COVID in cancer patients in Italy was 2%; must take them as high risk patients
  • they were not prepared for pandemic lasting for months instead of days; March 15 in middle of outbreak they started TERAVOLT registry; by March 26 had IRB approval; they are accruing 17 new patients per week; Ontario also joined in and has become worldwide (21 countries involved);  in registry they also included radiologic exams and COVID testing result
  • most patients were males and many smokers; 75% had SCLC; 83% of cases had one comorbility like hypertension and one third had at least one comorbility; 73.9% of patients were on treatment (they see this in their clinic: 30% on chemo or TKI alone; other patients were just on folowup
  • most of symptoms overlap with symptoms of lung cancer like pneumonia and pneumonitits and multi organ failure; most were hospitalized
  • unexpected high mortality among lung cancer patients with COVID19; this mortality seems due to COVID and not to cancer;
  • study had some limitations like short followup and some surgical cases so some bias may be present
  • she stresses don’t go it alone and make your own registry JOIN A REGISTRY

 

Outcome of cancer patients infected with COVID-19, including toxicity of cancer treatments
Fabrice Barlesi @barlesi
Gustave Roussy Cancer Campus

Professor Fabrice Barlesi
 As a specialist in lung cancer, precision medicine and cancer immunology, Prof. Fabrice Barlesi is a major contributor to research in the field of novel oncological therapies. He was apppointed General Director of Gustave Roussy in January 2020.
Fabrice Barlesi is Professor of Medicine at the University of Aix-Marseille. He has been head of the Multidisciplinary Oncology and Innovative Therapies Department of the Nord Hospital in Marseille (Marseille Public Hospitals) and the Marseille Centre for Early Trials in Oncology (CLIP2) which were established by him. He holds a doctorate in Sciences and Management with methods of analysis of health care systems, together with an ESSEC (international business school) master’s degree in general hospital management.
Professor Barlesi was also a co-founder of the Marseille Immunopôle French Immunology network, which aims to coordinate immunological expertise in the Aix-Marseille metropolitan area. In this context, he has organised PIONeeR (Investment in the future RHU 2017), the major international Hospital-University research project whose objective is to improve understanding of resistance to immunotherapy – anti-PD1(L1) – in lung cancer and help to prevent and overcome it. He was also vice-chair of the PACA (Provence, Alps and Côte d’Azur) Region Cancer Research Directorate.
Professor Barlesi is the author and co-author of some 300 articles in international journals and specialist publications. In 2018, the European Society of Medical Oncology (ESMO) and the International Association for the Study of Lung Cancer (IASLC) awarded him the prestigious Heine H. Hansen prize. He appears in the 2019 world list of most influential researchers (Highly cited researchers, Web of Science Group).
  • March 14 started protective measures and at peak had increased commited beds at highest rate
  • 12% of cancer patients tested positive for COVID; (by RTPCR); they curated data across different chemo regimens used
  • they retrospectively collected data; primary endpoint was clinical worsening; median of disease 13 days;
  • they actually had more breast cancer patients and other solid malignancies; 23% of covid cases no symptoms; 83% finally did have the symptoms after followup; diarhea actually in 10% of cases so clinics are seeing this as a symptom
  • CT scan showed 66% cases had pneumonitits like display; 25% patients were managed as outpatient
  • 24% patients worsened during treatment but 75% were able to go home (treated at home or well)
  • I/O did not have negative outcome and you can use these drugs without increasing risk to COVID
  • although many clinical trials have been hindered they are actively recruiting for COVID-cancer studies
  • outcomes with respect to death and symptoms are comparable to worldwide stats

Adapting oncologic practice to COVID19 outbreak: From outpatient triage to risk assessment for specific treatment in Madrid, Spain
Carlos Gomez-Martin
Octubre University Hospital

  • MOST slides were DO NOT POST so as requested data will not be shown; this study will be published soon
  • Summary is that Spain is seeing statistics like other European countries and similar results
  • Tocilizumab, the IL6 antagonists had been suggested as a treatment for cytokine storm and they are involved in a trial with this agent; results will be published

Experience in using oncology drugs in patients with COVID-19

Paolo A. Ascierto
Istituto Nazionale Tumori IRCCS Fondazione Pascale

  • giving surgery only for patients at highest risk of cancer mortality so using neoadjuvant therapy more often
  • telemedicine is a viable strategy for patient consult
  • for metastatic melanoma they are given highest priority for treatment
  • they are conducting a tocilizumab clinical trial and have accrued over 300 patients
  • results are in press so please look for publication soon
  • also can use TNF inhibitor, JAK inhibitor, IL1 inhibitor to treat cytokine storm

COVID-19 and cancer: Flattening the curve but widening disparities
Louis P. Voigt
Memorial Sloan Kettering Cancer Center

  • Sloan has performed about 5000 COVID tests;  78 patients needed hospitilization; 15 died; 40% still in ICU
  • they do see many African American patients
  • mortality rates in US (published) have been around 50-60 % for cancer patients with COVID; Sloan prelim results are lower but still accruing data

Patients with cancer appear more vulnerable to SARS-COV-2: A multi-center study during the COVID-19 outbreak
Hongbing Cai
Zhongnan Hospital of Wuhan University

  • metastatic cancer showed much higher risk than non cancer but non metastatic showed increased risk too
  • main criteria of outcome was ICU admission
  • patients need to be isolated and personalized treatment plans need to be made
  • many comparisons were between non cancer and cancer which was clearest significance; had not looked at cancer types or stage grade or treatment
  • it appears that there are more questions right now than answers so data collection is a priority

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For other Articles on the Online Open Access Journal on COVID19 and Cancer please see

https://pharmaceuticalintelligence.com/coronavirus-portal/

Opinion Articles from the Lancet: COVID-19 and Cancer Care in China and Africa

Actemra, immunosuppressive which was designed to treat rheumatoid arthritis but also approved in 2017 to treat cytokine storms in cancer patients SAVED the sickest of all COVID-19 patients

The Second in a Series of Virtual Town Halls with Leading Oncologist on Cancer Patient Care during COVID-19 Pandemic: What you need to know

Responses to the COVID-19 outbreak from Oncologists, Cancer Societies and the NCI: Important information for cancer patients

 

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Opinion Articles from the Lancet: COVID-19 and Cancer Care in China and Africa

Posted in Biomarkers: Inflammation, Cancer - General, Cancer and Current Therapeutics, Cancer Prevention: Research & Programs, Cancer Researchers Fighting COVID-19, Cancer Screening, Coronavirus Gene Expression, COVID-19, COVID-19: Pandemic Surgery Guidance, Economic Impact of Coronavirus Pandemic, interventional oncology, number of asymptomatic infections, Population genetics, Population Health Management, Population Health Management, Genetics & Pharmaceutical, SAR-Cov-2 a vasculotropic (blood vessels) RNA Virus, SARS-CoV-2, Seasonality & Environmental Factors in Resurgence, Serology tests for coronavirus antibodies, Treatment Protocols for COVID-19, Virus Infective Acute Respiratory Syndrome: SARS-CoV, tagged , , , , , , , , , on April 25, 2020| Leave a Comment »

Opinion Articles from the Lancet: COVID-19 and Cancer Care in China and Africa

Reporter: Stephen J. Williams, PhD

Cancer Patients in SARS-CoV-2 infection: a nationwide analysis in China

Wenhua Liang, Weijie Guan, Ruchong Chen, Wei Wang, Jianfu Li, Ke Xu, Caichen Li, Qing Ai, Weixiang Lu, Hengrui Liang, Shiyue Li, Jianxing He

Lancet Oncol. 2020 Mar; 21(3): 335–337. Published online 2020 Feb 14. doi: 10.1016/S1470-2045(20)30096-6

PMCID: PMC7159000

 

The National Clinical Research Center for Respiratory Disease and the National Health Commission of the People’s Republic of China collaborated to establish a prospective cohort to monitor COVID-19 cases in China.  As on Jan31, 20202007 cases have been collected and analyzed with confirmed COVID-19 infection in these cohorts.

Results: 18 or 1% of COVID-19 cases had a history of cancer (the overall average cancer incidence in the overall China population is 0.29%) {2015 statistics}.  It appeared that cancer patients had an observable higher risk of COVID related complications upon hospitalization. However, this was a higher risk compared with the general population.  There was no comparison between cancer patients not diagnosed with COVID-19 and an assessment of their risk of infection.  Interestingly those who were also cancer survivors showed an increased incidence of COVID related severe complications compared to the no cancer group.

Although this study could have compared the risk within a cancer group, the authors still felt the results warranted precautions when dealing with cancer patients and issued recommendations including:

  1. Postponing of adjuvant chemotherapy or elective surgery for stable cancer should be considered
  2. Stronger personal protection for cancer patients
  3. More intensive surveillance or treatment should be considered when patients with cancer are infected, especially in older patients

Further studies will need to address the risk added by specific types of chemotherapy: cytolytic versus immunotherapy e.g.

 

Preparedness for COVID-19 in the oncology community in Africa

Lancet Oncology, Verna Vanderpuye, Moawia Mohammed,Ali Elhassan

Hannah Simonds: Published:April 03, 2020DOI:https://doi.org/10.1016/S1470-2045(20)30220-5

Africa has a heterogeneity of cultures, economies and disease patterns however fortunately it is one of the last countries to be hit by the COVID-19 pandemic, which allows some time for preparation by the African nations.  The authors note that with Africa’s previous experiences with epidemics, namely ebola and cholera, Africa should be prepared for this pandemic.

However, as a result of poor economic discipline, weak health systems, and poor health-seeking behaviors across the continent, outcomes could be dismal. Poverty, low health literacy rates, and cultural practices that negatively affect cancer outcomes will result in poor assimilation of COVID-19 containment strategies in Africa.”

In general African oncologists are following COVID-19 guidelines from other high-income countries, but as this writer acknowledges in previous posts, there was a significant lag from first cases in the United States to the concrete formulation of guidelines for both oncologists and patients with regard to this pandemic.  African oncologist are delaying the start of adjuvant therapies and switching more to oral therapies and rethink palliative care.

However the authors still have many more questions than answers, however even among countries that have dealt with this pandemic before Africa (like Italy and US), oncologists across the globe still have not been able to answer questions like: what if my patient develops a fever, what do I do during a period of neutropenia, to their satisfaction or the satisfaction of the patient.  These are questions even oncologists who are dealing in COVID hotspots are still trying to answer including what constitutes a necessary surgical procedure? As I have highlighted in recent posts, oncologists in New York have all but shut down all surgical procedures and relying on liquid biopsies taken in the at-home setting. But does Africa have this capability of access to at home liquid biopsy procedures?

In addition, as I had just highlighted in a recent posting, there exists extreme cancer health disparities across the African continent, as well as the COVID responses. In West Africa, COVID-19 protocols are defined at individual institutions.  This is more like the American system where even NCI designated centers were left to fashion some of their own guidelines initially, although individual oncologists had banded together to do impromptu meetings to discuss best practices. However this is fine for big institutions, but as in the US, there is a large rural population on the African continent with geographical barriers to these big centers. Elective procedures have been cancelled and small number of patients are seen by day.  This remote strategy actually may be well suited for African versus more developed nations, as highlighted in a post I did about mobile health app use in oncology, as this telemedicine strategy is rather new among US oncologists (reference my posts with the Town Hall meetings).

The situation is more complicated in South Africa where they are dealing with an HIV epidemic, where about 8 million are infected with HIV. Oncology services here are still expecting to run at full capacity as the local hospitals deal with the first signs of the COVID outbreak. In Sudan, despite low COVID numbers, cancer centers have developed contingency plans. and are deferring new referrals except for emergency cases.  Training sessions for staff have been developed.

For more articles in this online open access journal on Cancer and COVID-19 please see our

Coronovirus Portal
Responses to the #COVID-19 outbreak from Oncologists, Cancer Societies and the NCI: Important information for cancer patients

 

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Loss of Smell and Taste Part of Screening for COVID-19

Posted in Economic Impact of Coronavirus Pandemic, Population Health Management, Genetics & Pharmaceutical, SARS-CoV-2, Seasonality & Environmental Factors in Resurgence, tagged , , , , on April 23, 2020| Leave a Comment »

Loss of Smell and Taste Part of Screening for COVID-19

Reporter: Irina Robu, PhD

While brewing your morning coffee, you suddenly realize that you can’t smell the freshly ground beans, could you have COVID-19?

Doctors around the world began sharing reports of smell and taste loss in April 2020 in patients with confirmed cased of COVID-19. They suggested that these could serve as an early sign of infection, signaling people to self-quarantine before they develop a cough or fever. It is well known, that a variety of viruses can attack the cranial nerves related to smell that surrounds those nerves.

COVID-19 is known to cause inflammation, either directly around the nerve in the nasal lining and/or within the nerve itself. When the nerve is either surrounded by inflammatory molecules or has a lot of inflammation within the nerve cell body, it cannot function correctly. Even though it may not affect every patient with COVID-19, loss of smell and taste is certainly associated with the disease and in some countries such as France is used as a triage mechanism.

Dr. Zara Patel, Stanford professor of otolaryngology conducted a control study to compare the incidence of cranial neuropathies in two patients’ groups looking at family of neurologic disease such as Alzheimer’s disease, Parkinson’s disease and stroke. Ninety-one patients had post-viral olfactory loss and 100 were controls; and they were matched as closely as possible for age and gender. Patients with olfactory loss had six-times higher odds of having other cranial neuropathies than the control group — with an incidence rate of other cranial nerve deficits of 11% and 2%, respectively. Family history of neurologic diseases was associated with more than two-fold greater odds of having a cranial nerve deficit. Although we had a small sample size, the striking difference between the groups implies that it is worthwhile to research this with a larger population.

Their results show that patients may have inherent vulnerabilities to neural damage or decreased ability of nerve recovery beyond risk factors such as age, body mass index and the duration of the loss before intervention. When a patient has a viral-induced inflammation of the nerve, doctors treat it with steroids to decrease the inflammation. But then again treating COVID-19 patients with steroids might be a bad idea since of its effect on the inflammatory processes going on in their heart and lungs. However, it is up to the doctor treating the patient to decide whether the patient needs to be tested for COVID-19 or self-isolate to circumvent being a vector of the virus.

SOURCE

https://www.medscape.com/viewarticle/929116

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AAAS Science Podcast: Why some diseases are seasonal and some are not: Coronaviruses and more

Posted in Biomarkers: Inflammation, Coronavirus Gene Expression, COVID-19, Economic Impact of Coronavirus Pandemic, number of asymptomatic infections, Population genetics, Population Health Management, SARS-CoV-2, Seasonality & Environmental Factors in Resurgence, Treatment Protocols for COVID-19, Vaccinology, Virus Infective Acute Respiratory Syndrome: SARS-CoV, tagged , , , on April 17, 2020| Leave a Comment »

AAAS Science Podcast: Why some diseases are seasonal and some are not: Coronaviruses and more

Reporter: Stephen J. Williams, PhD

 

The following podcast from the American Association for Advancement of Science (AAAS) discusses the seasonality of some viruses while other viruses are able to manifest themselves in different seasons over the globe.

Please Play

https://play.google.com/music/m/Da3pxbfyuykjy3r7xe5rprupmdq?t=Why_some_diseases_come_and_go_with_the_seasons_and_how_to_develop_smarter_safer_chemicals-Science_Ma

For more articles on COVID19 and SARS-CoV-2 on this Open Access Online Journal please see

Coronavirus SARS-CoV-2 Portal

 

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Updated listing of COVID-19 vaccine and therapeutic trials from NIH Clinical Trials.gov

Posted in Biomarkers: Inflammation, Clinical Diagnostics, Clinical Genomics, COVID-19, COVID-19: Pandemic Surgery Guidance, Drug Development Process, Economic Impact of Coronavirus Pandemic, FDA, FDA Regulatory Affairs, Immune-Mediation (independent immunopathology: lung and reticuloendothelial system), Infectious Disease & New Antibiotic Targets, Infectious Disease Immunodiagnostics, number of asymptomatic infections, Pharmaceutical Drug Discovery, SAR-Cov-2 a vasculotropic (blood vessels) RNA Virus, SARS-CoV-2, Seasonality & Environmental Factors in Resurgence, Treatment Protocols for COVID-19, Viral diseases, tagged , , , , , on April 16, 2020| Leave a Comment »

Updated listing of COVID-19 vaccine and therapeutic trials from NIH Clinical Trials.gov

Curator: Stephen J. Williams, PhD

 

The following file contains an updated list (search on 4/15/2020) of COVID-19 related clinical trials from https://clinicaltrials.gov/

 

The Excel file can be uploaded here: Current Covid-19 Trials

 

Each sheet in the workbook is separated by current COVID-19 vaccine trials, currents COVID-19 trials with the IL6R (interleukin 6 receptor) antagonist tocilizumab, and all COVID related trials.  The Excel spreadsheet also contains links to more information about the trials.

 

As of April 15, 2020 the number of listed trials are as follows:

 

clinicaltrials.gov search terms Number of results Number of completed  trials Number of trials currently recruiting
COVID-19 or SARS-CoV-2 410 5 completed

5 withdrawn  

 192
1st row terms + vaccine 28 0 15
1st row terms + tocilizumab 16 0 10
1st row terms + hydroxychloroquine 61 1 22

 

A few highlights of the COVID related trials on clinicaltrials.gov

 

Withdrawn trials

 

Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 (NCT04287686)

Study Description

Go to 

Brief Summary:

This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.

 

Condition or disease  Intervention/treatment  Phase 
COVID-19 Drug: Recombinant human angiotensin-converting enzyme 2 (rhACE2) Not Applicable

 

Detailed Description:

This is a small pilot study investigating whether there is any efficacy signal that warrants a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It is not expected to produce statistically significant results in the major endpoints. The investigators will examine all of the biologic, physiological, and clinical data to determine whether a Phase 2B trial is warranted.

Primary efficacy analysis will be carried only on patients receiving at least 4 doses of active drug. Safety analysis will be carried out on all patients receiving at least one dose of active drug.

It is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to have at least 12 evaluable patients in each group.

Experimental group: 0.4 mg/kg rhACE2 IV BID and standard of care Control group: standard of care

Intervention duration: up to 7 days of therapy

No planned interim analysis.

Study was withdrawn before participants were enrolled.

Washed Microbiota Transplantation for Patients With 2019-nCoV Infection (NCT04251767)

Study Description

Go to 

Brief Summary:

Gut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.

 

Detailed Description:

An ongoing outbreak of 2019 novel coronavirus was reported in Wuhan, China. 2019-nCoV has caused a cluster of pneumonia cases, and posed continuing epidemic threat to China and even global health. Unfortunately, there is currently no specific effective treatment for the viral infection and the related serious complications. It is in urgent need to find a new specific effective treatment for the 2019-nCoV infection. According to Declaration of Helsinki and International Ethical Guidelines for Health-related Research Involving Humans, the desperately ill patients with 2019-nCov infection during disease outbreaks have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore unethical to restrict access to UMIs to the clinical trial context.

There is a vital link between the intestinal tract and respiratory tract, which was exemplified by intestinal complications during respiratory disease and vice versa. Some of these patients can develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. Additionally, the recent animal study provided direct evidence supporting that antibiotics could decrease gut microbiota and the lung stromal interferon signature and facilitate early influenza virus replication in lung epithelia. Importantly, the above antibiotics caused negative effects can be reversed by fecal microbiota transplantation (FMT) which suggested that FMT might be able to induce a significant improvement in the respiratory virus infection. Another evidence is that the microbiota could confer protection against certain virus infection such as influenza virus and respiratory syncytial virus by priming the immune response to viral evasion. The above results suggested that FMT might be a new therapeutic option for the treatment of virus-related pneumonia. The methodology of FMT recently was coined as WMT, which is dependent on the automatic facilities and washing process in a laboratory room. Patients underwent WMT with the decreased rate of adverse events and unchanged clinical efficacy in ulcerative colitis and Crohn’s disease. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.

 

Responsible Party: Faming Zhang, Director of Medical Center for Digestive Diseases, The Second Hospital of Nanjing Medical University
Identifier NCT04251767     History of Changes

Study was withdrawn before participants were enrolled.

 

Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus (NCT04293692)

Study Description

Go to 

Brief Summary:

The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.

Detailed Description:

Since late December 2019, human pneumonia cases infected by a novel coronavirus (2019-nCoV) were firstly identified in Wuhan, China. As the virus is contagious and of great epidemic, more and more cases have found in other areas of China and abroad. Up to February 24, a total of 77, 779 confirmed cases were reported in China. At present, there is no effective treatment for patients identified with novel coronavirus pneumonia. Therefore, it’s urgent to explore more active therapeutic methods to cure the patients.

Recently, some clinical researches about the 2019 novel coronavirus pneumonia published in The Lancet and The New England Journal of Medicine suggested that massive inflammatory cell infiltration and inflammatory cytokines secretion were found in patients’ lungs, alveolar epithelial cells and capillary endothelial cells were damaged, causing acute lung injury. It seems that the key to cure the pneumonia is to inhibit the inflammatory response, resulting to reduce the damage of alveolar epithelial cells and endothelial cells and repair the function of the lung.

Mesenchymal stem cells (MSCs) are widely used in basic research and clinical application. They are proved to migrate to damaged tissues, exert anti-inflammatory and immunoregulatory functions, promote the regeneration of damaged tissues and inhibit tissue fibrosis. Studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 viruses by reducing the levels of proinflammatory cytokines and the recruitment of inflammatory cells into the lungs. Compared with MSCs from other sources, human umbilical cord-derived MSCs (UC-MSCs) have been widely applied to various diseases due to their convenient collection, no ethical controversy, low immunogenicity, and rapid proliferation rate. In our recent research, we confirmed that UC-MSCs can significantly reduce inflammatory cell infiltration and inflammatory factors expression in lung tissue, and significantly protect lung tissue from endotoxin (LPS) -induced acute lung injury in mice.

The purpose of this clinical study is to investigate safety and efficiency of UC-MSCs in treating pneumonia patients infected by 2019-nCoV. The investigators planned to recruit 48 patients aged from 18 to 75 years old and had no severe underlying diseases. In the cell treatment group, 24 patients received 0.5*10E6 UC-MSCs /kg body weight intravenously treatment 4 times every other day besides conventional treatment. In the control group, other 24 patients received conventional treatment plus 4 times of placebo intravenously. The lung CT, blood biochemical examination, lymphocyte subsets, inflammatory factors, 28-days mortality, etc will be evaluated within 24h and 1, 2, 4, 8 weeks after UC-MSCs treatment.

Sponsor:

Puren Hospital Affiliated to Wuhan University of Science and Technology

Collaborator:

Wuhan Hamilton Bio-technology Co., Ltd

Study was withdrawn before participants were enrolled.

 

Prognositc Factors in COVID-19 Patients Complicated With Hypertension (NCT04272710)

Study Description

Brief Summary:

There are currently no clinical studies reporting clinical characteristics difference between the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China

Detailed Description:

At present, the outbreak of the new coronavirus (2019-nCoV) infection in Wuhan and Hubei provinces has attracted great attention from the medical community across the country. Both 2019-nCoV and SARS viruses are coronaviruses, and they have a large homology.

Published laboratory studies have suggested that SARS virus infection and its lung injury are related to angiotensin-converting enzyme 2 (ACE2) in lung tissue. And ACE and ACE2 in the renin-angiotensin system (RAS) are vital central links to maintain hemodynamic stability and normal heart and kidney function in vivo.

A large amount of evidence-based medical evidence shows that ACE inhibitors are the basic therapeutic drugs for maintaining hypertension, reducing the risk of cardiovascular, cerebrovascular, and renal adverse events, improving quality of life, and prolonging life in patients with hypertension. Recent experimental studies suggest that treatment with ACE inhibitors can significantly reduce pulmonary inflammation and cytokine release caused by coronavirus infection.

 

ACEI treatment

hypertension patients with ACEI treatment when suffered with novel coronavirus infection in China
Control

hypertension patients without ACEI treatment when suffered with novel coronavirus infection in China

 

Locations

China
The First Affiliated Hospital of Chongqing Medical University Chongqing, China

Sponsors and Collaborators Chongqing Medical University

 

Responsible PI: Dongying Zhang, Associate Professor, Chongqing Medical University

Withdrawn (Similar projects have been registered, and it needs to be withdrawn.)

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US Responses to Coronavirus Outbreak Expose Many Flaws in Our Medical System

Posted in and Bioethics, Bio-Ethics, Biomarkers: Inflammation, coronavirus, Coronavirus Gene Expression, COVID-19, COVID-19 effects on Human Heart, COVID-19: Pandemic Surgery Guidance, Economic Impact of Coronavirus Pandemic, Ethics and Leadership, Federal Budget Appropriations, Health Economics and Outcomes Research, Health Law & Patient Safety, Health Law Policy, Healthcare costs and reimbursement, Healthcare Reform, Hospital-based Medical Innovations, Immune-Mediation (independent immunopathology: lung and reticuloendothelial system), Key Opinion Leaders in eScientific Publishing - Interviews with, Law and Medicine Conflicts, Leadership, Power, Social Interlocking Connections, number of asymptomatic infections, Patents, Patient Experience, Patient Experience: Personal Memories of Invasive Medical Intervantion, Patient Outlook, Patient’s Voice: Personal Experience with Invasive Medical Procedures, Population genetics, Population Health Management, Population Health Management, Genetics & Pharmaceutical, SARS-CoV-2, Seasonality & Environmental Factors in Resurgence, Serology tests for coronavirus antibodies, Support Staff, Treatment Protocols for COVID-19, United States, Vaccinology, Virus Infective Acute Respiratory Syndrome: SARS-CoV, tagged , , , , , , , , , , , on March 25, 2020| Leave a Comment »

US Responses to Coronavirus Outbreak Expose Many Flaws in Our Medical System

Curator: Stephen J. Williams, Ph.D.

The  coronavirus pandemic has affected almost every country in every continent however, after months of the novel advent of novel COVID-19 cases, it has become apparent that the varied clinical responses in this epidemic (and outcomes) have laid bare some of the strong and weak aspects in, both our worldwide capabilities to respond to infectious outbreaks in a global coordinated response and in individual countries’ response to their localized epidemics.

 

Some nations, like Israel, have initiated a coordinated government-private-health system wide action plan and have shown success in limiting both new cases and COVID-19 related deaths.  After the initial Wuhan China outbreak, China closed borders and the government initiated health related procedures including the building of new hospitals. As of writing today, Wuhan has experienced no new cases of COVID-19 for two straight days.

 

However, the response in the US has been perplexing and has highlighted some glaring problems that have been augmented in this crisis, in the view of this writer.    In my view, which has been formulated after social discussion with members in the field ,these issues can be centered on three major areas of deficiencies in the United States that have hindered a rapid and successful response to this current crisis and potential future crises of this nature.

 

 

  1. The mistrust or misunderstanding of science in the United States
  2. Lack of communication and connection between patients and those involved in the healthcare industry
  3. Socio-geographical inequalities within the US healthcare system

 

1. The mistrust or misunderstanding of science in the United States

 

For the past decade, anyone involved in science, whether directly as active bench scientists, regulatory scientists, scientists involved in science and health policy, or environmental scientists can attest to the constant pressure to not only defend their profession but also to defend the entire scientific process and community from an onslaught of misinformation, mistrust and anxiety toward the field of science.  This can be seen in many of the editorials in scientific publications including the journal Science and Scientific American (as shown below)

 

Stepping Away from Microscopes, Thousands Protest War on Science

Boston rally coincides with annual American Association for the Advancement of Science (AAAS) conference and is a precursor to the March for Science in Washington, D.C.

byLauren McCauley, staff writer

Responding to the troubling suppression of science under the Trump administration, thousands of scientists, allies, and frontline communities are holding a rally in Boston’s Copley Square on Sunday.

#standupforscience Tweets

 

“Science serves the common good,” reads the call to action. “It protects the health of our communities, the safety of our families, the education of our children, the foundation of our economy and jobs, and the future we all want to live in and preserve for coming generations.”

It continues: 

But it’s under attack—both science itself, and the unalienable rights that scientists help uphold and protect. 

From the muzzling of scientists and government agencies, to the immigration ban, the deletion of scientific data, and the de-funding of public science, the erosion of our institutions of science is a dangerous direction for our country. Real people and communities bear the brunt of these actions.

The rally was planned to coincide with the annual American Association for the Advancement of Science (AAAS) conference, which draws thousands of science professionals, and is a precursor to the March for Science in Washington, D.C. and in cities around the world on April 22.

 

Source: https://www.commondreams.org/news/2017/02/19/stepping-away-microscopes-thousands-protest-war-science

https://images.app.goo.gl/UXizCsX4g5wZjVtz9

 

https://www.washingtonpost.com/video/c/embed/85438fbe-278d-11e7-928e-3624539060e8

 

 

The American Association for Cancer Research (AACR) also had marches for public awareness of science and meaningful science policy at their annual conference in Washington, D.C. in 2017 (see here for free recordings of some talks including Joe Biden’s announcement of the Cancer Moonshot program) and also sponsored events such as the Rally for Medical Research.  This patient advocacy effort is led by the cancer clinicians and scientific researchers to rally public support for cancer research for the benefit of those affected by the disease.

Source: https://leadingdiscoveries.aacr.org/cancer-patients-front-and-center/

 

 

     However, some feel that scientists are being too sensitive and that science policy and science-based decision making may not be under that much of a threat in this country. Yet even as some people think that there is no actual war on science and on scientists they realize that the public is not engaged in science and may not be sympathetic to the scientific process or trust scientists’ opinions. 

 

   

From Scientific American: Is There Really a War on Science? People who oppose vaccines, GMOs and climate change evidence may be more anxious than antagonistic

 

Certainly, opponents of genetically modified crops, vaccinations that are required for children and climate science have become louder and more organized in recent times. But opponents typically live in separate camps and protest single issues, not science as a whole, said science historian and philosopher Roberta Millstein of the University of California, Davis. She spoke at a standing-room only panel session at the American Association for the Advancement of Science’s annual meeting, held in Washington, D.C. All the speakers advocated for a scientifically informed citizenry and public policy, and most discouraged broadly applied battle-themed rhetoric.

 

Source: https://www.scientificamerican.com/article/is-there-really-a-war-on-science/

 

      In general, it appears to be a major misunderstanding by the public of the scientific process, and principles of scientific discovery, which may be the fault of miscommunication by scientists or agendas which have the goals of subverting or misdirecting public policy decisions from scientific discourse and investigation.

 

This can lead to an information vacuum, which, in this age of rapid social media communication,

can quickly perpetuate misinformation.

 

This perpetuation of misinformation was very evident in a Twitter feed discussion with Dr. Eric Topol, M.D. (cardiologist and Founder and Director of the Scripps Research Translational  Institute) on the US President’s tweet on the use of the antimalarial drug hydroxychloroquine based on President Trump referencing a single study in the International Journal of Antimicrobial Agents.  The Twitter thread became a sort of “scientific journal club” with input from international scientists discussing and critiquing the results in the paper.  

 

Please note that when we scientists CRITIQUE a paper it does not mean CRITICIZE it.  A critique is merely an in depth analysis of the results and conclusions with an open discussion on the paper.  This is part of the normal peer review process.

 

Below is the original Tweet by Dr. Eric Topol as well as the ensuing tweet thread

 

https://twitter.com/EricTopol/status/1241442247133900801?s=20

 

Within the tweet thread it was discussed some of the limitations or study design flaws of the referenced paper leading the scientists in this impromptu discussion that the study could not reasonably conclude that hydroxychloroquine was not a reliable therapeutic for this coronavirus strain.

 

The lesson: The public has to realize CRITIQUE does not mean CRITICISM.

 

Scientific discourse has to occur to allow for the proper critique of results.  When this is allowed science becomes better, more robust, and we protect ourselves from maybe heading down an incorrect path, which may have major impacts on a clinical outcome, in this case.

 

 

2.  Lack of communication and connection between patients and those involved in the healthcare industry

 

In normal times, it is imperative for the patient-physician relationship to be intact in order for the physician to be able to communicate proper information to their patient during and after therapy/care.  In these critical times, this relationship and good communication skills becomes even more important.

 

Recently, I have had multiple communications, either through Twitter, Facebook, and other social media outlets with cancer patients, cancer advocacy groups, and cancer survivorship forums concerning their risks of getting infected with the coronavirus and how they should handle various aspects of their therapy, whether they were currently undergoing therapy or just about to start chemotherapy.  This made me realize that there were a huge subset of patients who were not receiving all the information and support they needed; namely patients who are immunocompromised.

 

These are patients represent

  1. cancer patient undergoing/or about to start chemotherapy
  2. Patients taking immunosuppressive drugs: organ transplant recipients, patients with autoimmune diseases, multiple sclerosis patients
  3. Patients with immunodeficiency disorders

 

These concerns prompted me to write a posting curating the guidance from National Cancer Institute (NCI) designated cancer centers to cancer patients concerning their risk to COVID19 (which can be found here).

 

Surprisingly, there were only 14 of the 51 US NCI Cancer Centers which had posted guidance (either there own or from organizations like NCI or the National Cancer Coalition Network (NCCN).  Most of the guidance to patients had stemmed from a paper written by Dr. Markham of the Fred Hutchinson Cancer Center in Seattle Washington, the first major US city which was impacted by COVID19.

 

Also I was surprised at the reactions to this posting, with patients and oncologists enthusiastic to discuss concerns around the coronavirus problem.  This led to having additional contact with patients and oncologists who, as I was surprised, are not having these conversations with each other or are totally confused on courses of action during this pandemic.  There was a true need for each party, both patients/caregivers and physicians/oncologists to be able to communicate with each other and disseminate good information.

 

Last night there was a Tweet conversation on Twitter #OTChat sponsored by @OncologyTimes.  A few tweets are included below

https://twitter.com/OncologyTimes/status/1242611841613864960?s=20

https://twitter.com/OncologyTimes/status/1242616756658753538?s=20

https://twitter.com/OncologyTimes/status/1242615906846547978?s=20

 

The Lesson:  Rapid Communication of Vital Information in times of stress is crucial in maintaining a good patient/physician relationship and preventing Misinformation.

 

3.  Socio-geographical Inequalities in the US Healthcare System

It has become very clear that the US healthcare system is fractioned and multiple inequalities (based on race, sex, geography, socio-economic status, age) exist across the whole healthcare system.  These inequalities are exacerbated in times of stress, especially when access to care is limited.

 

An example:

 

On May 12, 2015, an Amtrak Northeast Regional train from Washington, D.C. bound for New York City derailed and wrecked on the Northeast Corridor in the Port Richmond neighborhood of Philadelphia, Pennsylvania. Of 238 passengers and 5 crew on board, 8 were killed and over 200 injured, 11 critically. The train was traveling at 102 mph (164 km/h) in a 50 mph (80 km/h) zone of curved tracks when it derailed.[3]

Some of the passengers had to be extricated from the wrecked cars. Many of the passengers and local residents helped first responders during the rescue operation. Five local hospitals treated the injured. The derailment disrupted train service for several days. 

(Source Wikipedia https://en.wikipedia.org/wiki/2015_Philadelphia_train_derailment)

What was not reported was the difficulties that first responders, namely paramedics had in finding an emergency room capable of taking on the massive load of patients.  In the years prior to this accident, several hospitals, due to monetary reasons, had to close their emergency rooms or reduce them in size. In addition only two in Philadelphia were capable of accepting gun shot victims (Temple University Hospital was the closest to the derailment but one of the emergency rooms which would accept gun shot victims. This was important as Temple University ER, being in North Philadelphia, is usually very busy on any given night.  The stress to the local health system revealed how one disaster could easily overburden many hospitals.

 

Over the past decade many hospitals, especially rural hospitals, have been shuttered or consolidated into bigger health systems.  The graphic below shows this

From Bloomberg: US Hospital Closings Leave Patients with Nowhere to go

 

 

https://images.app.goo.gl/JdZ6UtaG3Ra3EA3J8

 

Note the huge swath of hospital closures in the midwest, especially in rural areas.  This has become an ongoing problem as the health care system deals with rising costs.

 

Lesson:  Epidemic Stresses an already stressed out US healthcare system

 

Please see our Coronavirus Portal at

https://pharmaceuticalintelligence.com/coronavirus-portal/

 

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