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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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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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Curation of Resources for High Risk People  to COVID-19 Infection: Guidances for Transplant Patients

Posted in COVID-19, COVID-19: Pandemic Surgery Guidance, Economic Impact of Coronavirus Pandemic, Immune-Mediation (independent immunopathology: lung and reticuloendothelial system), number of asymptomatic infections, Patient Experience: Personal Memories of Invasive Medical Intervantion, Patient Outlook, SAR-Cov-2 a vasculotropic (blood vessels) RNA Virus, SARS-CoV-2, SARS-COV2 Hijacking the Complement and Coagulation Systems, Serology tests for coronavirus antibodies, Supportive therapies, Surgical Procedure, Treatment Protocols for COVID-19, Vaccinology, Virus Infective Acute Respiratory Syndrome: SARS-CoV, tagged , , , , , , , , , , , on April 2, 2020| Leave a Comment »

Curation of Resources for High Risk People  to COVID-19 Infection :Guidances for Transplant Patients

Curator: Stephen J. Williams, PhD

 

From the American Society of Transplantation

Source: https://www.myast.org/information-transplant-professionals-and-community-members-regarding-2019-novel-coronavirus

INFORMATION FOR TRANSPLANT PROFESSIONALS AND COMMUNITY MEMBERS REGARDING 2019 NOVEL CORONAVIRUS

The recent outbreak of a novel coronavirus (COVID-19) in Wuhan, Hubei Province, China and the finding of infection in many other countries including the United States has led to questions among transplant programs, Organ Procurement Organizations (OPOs) and patients. The Organ Procurement and Transplantation Network (OPTN) strives to provide up-to-date information to answer these questions and to provide guidance as needed. Accordingly, the OPTN Ad Hoc Donor Transmission Advisory Committee (DTAC), American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS), after careful review of information available from the Centers for Disease Control and Prevention (CDC), offers information to transplant programs and OPOs in light of these concerns. Please visit the OPTN  website for more information.

The American Society of Transplantation recently conducted a Town Hall on guidances for transplant patients with regard to the COVID-19 pandemic.  A video recording of the Town Hall is given below

 

 

Description of the Town Hall by the AST: A number of transplant organizations from around the world have partnered to develop this educational webinar for the organ donation and transplantation communities. Our goal is to share experiences to date and respond to your questions about the impact of COVID-19 on organ donation and transplantation.

 

This webinar was recorded on March 23, 2020.

 

Resource Handout: https://www.myast.org/sites/default/f…

AST COVID-19 Page: https://www.myast.org/covid-19-inform…

 

The American Society of Transplantation has other up to date resources on their webpage at https://www.myast.org/covid-19-information#

AST Resources For Transplant Professionals 

Information for Transplant Professionals (Updated 3/31/20)

Medication Access and Drug Shortage Concerns During the COVID-19 Pandemic: Frequently Asked Questions (posted 3/31/20)

AST Resources For Transplant Recipients and Candidates 

Information for Transplant Recipients and Candidates (Updated 3/30/20)

Other Resources like videos and further articles

Frequently Asked Questions can be found here https://www.myast.org/coronavirus-disease-2019-covid-19-frequently-asked-questions-transplant-candidates-and-recipients

Mark Spigler from the American Kidney Fund listed some tips specifically for kidney transplant recipients. In his blog

Coronavirus, COVID-19 and kidney patients: what you need to know he wrote:

Because transplant recipients take immunosuppressive drugs, they are at higher risk of infection from viruses such as cold or flu. To limit the possibility of being exposed to the coronavirus that causes COVID-19, transplant patients should follow the CDC’s tips to avoid catching or spreading germs, and contact their health care provider if they develop cold or flu-like symptoms. By being informed and taking your own personal precautions, you can help reduce your risk of coming in contact with the coronavirus that causes COVID-19. You can find more information and resources for kidney patients by visiting our special coronavirus webpage at KidneyFund.org/coronavirus. We’ll update the page with important information for kidney patients and their caregivers as the coronavirus crisis continues to unfold.

Resources from the National Kidney Foundation

Source: https://www.kidney.org/coronavirus/transplant-coronavirus

Coronavirus and Kidney Transplants (please click on the links below)

For more information concerning various issues on COVID-19 please see our Coronavirus Portal at:

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

 

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From @Harvardmed Center for Bioethics: The Medical Ethics of the Corona Virus Crisis

Posted in Bio-Ethics, Biomarkers: Inflammation, COVID-19, Economic Impact of Coronavirus Pandemic, Ethics and Leadership, number of asymptomatic infections, Population Health Management, Population Health Management, Genetics & Pharmaceutical, SAR-Cov-2 a vasculotropic (blood vessels) RNA Virus, SARS-CoV-2, U.S. Employment-to-Population Ratio, Virus Infective Acute Respiratory Syndrome: SARS-CoV, Voices of Patients and Healthcare Providers, tagged , , , , , , , , on March 27, 2020| Leave a Comment »

From @Harvardmed Center for Bioethics: The Medical Ethics of the Corona Virus Crisis

Reporter: Stephen J. Williams, Ph.D.

From Harvard Medical School Center for Bioethics

source: https://bioethics.hms.harvard.edu/news/medical-ethics-corona-virus-crisis

The Medical Ethics of the Corona Virus Crisis

Executive Director Christine Mitchell discusses the importance of institutions talking through the implications of their decisions with the New Yorker.

By Isaac Chotiner 

Center Executive Director Christine Mitchell spoke with the New Yorker’s Isaac Chotiner about the decisions that may need to be made on limiting movement and, potentially, rationing supplies and hospital space.

“So, in the debate about allocating resources in a pandemic, we have to work with our colleagues around what kind of space is going to be made available—which means that other people and other services have to be dislocated—what kind of supplies we’re going to have, whether we’re going to reuse them, how we will reallocate staff, whether we can have staff who are not specialists take care of patients because we have way more patients than the number of specialized staff,” says Mitchell.

Read the full Q&A in the New Yorker.

 

Note: The following is taken from the Interview in the New Yorker.

As the novel coronavirus, covid-19, spreads across the globe, governments have been taking increasingly severe measures to limit the virus’s infection rate. China, where it originated, has instituted quarantines in areas with a large number of cases, and Italy—which is now facing perhaps the most serious threat outside of China—is entirely under quarantine. In the United States, the National Guard has been deployed to manage a “containment area” in New Rochelle, New York, where one of the country’s largest clusters has emerged. As the number of cases rises, we will soon face decisions on limiting movement and, potentially, rationing supplies and hospital space. These issues will be decided at the highest level by politicians, but they are often influenced by medical ethicists, who advise governments and other institutions about the way to handle medical emergencies.

One of those ethicists, with whom I recently spoke by phone, is Christine Mitchell, the executive director at the Center for Bioethics at Harvard Medical School. Mitchell, who has master’s degrees in nursing and philosophical and religious ethics, has been a clinical ethicist for thirty years. She founded the ethics program at Boston Children’s Hospital, and has served on national and international medical-ethics commissions. During our conversation, which has been edited for length and clarity, we discussed what ethicists tend to focus on during a health crisis, how existing health-care access affects crisis response, and the importance of institutions talking through the ethical implications of their decisions.

What coronavirus-related issue has most occupied your mental space over the past weeks?

The New Yorker’s coronavirus news coverage and analysis are free for all readers.

One of the things I think about but that we don’t often have an opportunity to talk about, when we are mostly focussing on what clinicians are doing and trying to prepare for, is the more general ways this affects our society. People get sick out there in the real world, and then they come to our hospitals, but, when they are sick, a whole bunch of them don’t have health insurance, or are afraid to come to a hospital, or they don’t have coverage for sick time or taking a day off when their child is sick, so they send their child to school. So these all have very significant influences on our ability to manage population health and community transmission that aren’t things that nurses and physicians and people who work in acute-care hospitals and clinics can really affect. They are elements of the way our society is structured and has failed to meet the needs of our general population, and they influence our ability to manage a crisis like this.

Is there anything specifically about a pandemic or something like coronavirus that makes these issues especially acute?

If a person doesn’t have health insurance and doesn’t come to be tested or treated, and if they don’t have sick-time coverage and can’t leave work, so they teach at a school, or they work at a restaurant, or do events that have large numbers of people, these are all ways in which the spread of a virus like this has to be managed—and yet can’t be managed effectively because of our social-welfare policies, not just our health-care resources.

Just to take a step back, and I want to get back to coronavirus stuff, but what got you interested in medical ethics?

What got me interested were the actual kinds of problems that came up when I was taking care of patients, starting as early as when I was in nursing school and was taking care of a patient who, as a teen-ager, had a terminal kind of cancer that his parents didn’t want him to know about, and which the health-care team had decided to defer to the parents. And yet I was spending every day taking care of him, and he was really puzzled about why he was so sick and whether he was going to get better, and so forth. And so of course I was faced with this question of, What do I do if he asks me? Which, of course, he did.

And this question about what you should tell an adolescent and whether the deference should be to his parents’ judgment about what’s best for him, which we would ordinarily respect, and the moral demands of the relationship that you have with a patient, was one of the cases that reminded me that there’s a lot more to being a nurse or a health-care provider than just knowing how to give cancer chemotherapy and change a bed, or change a dressing, or whatever. That a lot of it is in the relationship you have with a patient and the kinds of ethical choices they and their families are facing. They need your information, but also your help as they think things through. That’s the kind of thing that got me interested in it. There are a whole host of those kinds of cases, but they’re more individual cases.

As I began to work in a hospital as an ethicist, I began to worry about the broader organizational issues, like emergency preparedness. Some years ago, here in Boston, I had a joint appointment running the ethics program at Children’s Hospital and doing clinical ethics at Harvard Medical School. We pulled together a group, with the Department of Public Health and the emergency-preparedness clinicians in the Harvard-affiliated hospitals, to look at what the response within the state of Massachusetts should be to big, major disasters or rolling pandemics, and worked on some guidelines together.

When you looked at the response of our government, in a place like Washington State or in New York City, what things, from a medical-ethics perspective, are you noticing that are either good or maybe not so good?

To be candid and, probably, to use language that’s too sharp for publication, I’m appalled. We didn’t get ourselves ready. We’ve had outbreaks—sars in 2003, H1N1 in 2009, Ebola in 2013, Zika in 2016. We’ve known, and the general population in some ways has known. They even have movies like “Contagion” that did a great job of sharing publicly what this is like, although it is fictional, and that we were going to have these kinds of infectious diseases in a global community that we have to be prepared to handle. And we didn’t get ourselves as ready, in most cases, as we should have. There have been all these cuts to the C.D.C. budget, and the person who was the Ebola czar no longer exists in the new Administration.

And it’s not just this Administration. But the thing about this Administration that perhaps worries me the most is a fundamental lack of respect for science and the facts. Managing the crisis from a public-relations perspective and an economic, Dow Jones perspective are important, but they shouldn’t be fudging the facts. And that’s the piece that makes me feel most concerned—and not just as an ethicist. And then, of course, I want to see public education and information that’s forthright and helps people get the treatment that they need. But the disrespect for the public, and not providing honest information, is . . . yeah, that’s pretty disconcerting.

SOURCE

https://www.newyorker.com/news/q-and-a/the-medical-ethics-of-the-coronavirus-crisis

See more on this and #COVID19 on this Online Open Access Journal at our Coronavirus Portal at

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

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