How to Convert Doctors to Principal Investigators: Mayo Clinic’s National COVID-19 Convalescent Plasma Expanded Access Study

May 17, 2020 | Antibodies, Convalescent Plasma, COVID-19, Leading Sites, Mayo Clinic, News, SARS-CoV-2, Site Success, Site Watch

How to Convert Doctors to Principal Investigators Mayo Clinic’s National COVID-19 Convalescent Plasma Expanded Access Study

Back in early April, TrialSite News received huge interest in a national COVID-19 Convalescent Plasma study titled “Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19” led by Michael Joyner of the Mayo Clinic. Upon our promotion of this important national expansion access initiative, dozens of physicians contacted TrialSite News to inquire about how to participate—essentially how to become an investigator for this important effort. As we know, only a small percentage of U.S.-based doctors serve as principal investigators—perhaps 3% to 5% of the total—and hence at the time, we thought the interest was noteworthy. Hence we directed a number of physicians to Dr. Joyner and tracked this study with interest. Well, the study investigators were able to accumulate enough data to submit a paper, now pre-reviewed in the medRxiv preprint server. Based on the data generated from this incredibly prominent group of principal investigators, early indicators suggest that the transfusion of convalescent plasma is safe in hospitalized patients with COVID-19.

The Background

The only antibody-based therapy presently available for patients infected with SARS-CoV-2, the virus behind the COVID-19 pandemic, convalescent plasma (also known as convalescent blood products) are obtained by the collection of whole blood or plasma from a patient who has survived previous infection of COVID-19 and have developed humoral immunity against the SARS-CoV-2—as goes the premise—and are a possible source of specific antibodies of human origin.

The Study

Although definitely promising, this treatment approach manifest in the study hadn’t proven safe as a treatment for COVID-19. Consequently, the group analyzed key safety metrics post transfusion of ABO compatible human COVID-19 convalescent plasma in 5,000 hospitalized adults with severe or life threatening COVID-19, with 66^ in the intensive care unit, as part of the U.S. Food and Drug Administration (FDA) Expanded Access Program for COVID-19 convalescent plasma.

The Results

The research team reported total serious adverse events (SAEs) in the first hours post convalescent plasma transfusion was  <1%, including mortality rate (0.3%).  Out of 36 reported SAEs, 25 were related including mortality (n=4), transfusion-associated circulatory overload (TACO; n=7), transfusion-related acute lung injury (TRALI; n=11), and severe allergic transfusion reactions (n=3). Only 2 out of the 36 SAEs were assessed as definitely related to the convalescent transfusion associated with the study.  The overall mortality rate for the seven-day effort was 14.9%.

Conclusion

The study team faced crisis conditions at that point a month and a half ago—with a raging pandemic sweeping trough New York City and other metropolitan areas the resultant study pool represented a huge population of critically-ill patients: it was a scary situation. With the launch and execution of this study it is clear to the principal investigators that the early indicators suggest that the transfusion of convalescent plasma is safe in hospitalized patients with COVID-19.

Funding

The study was funded by the U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) grant; National Center for Advancing Translational Sciences (NCATS) grant; National Heart, Lung, and Blood Institute (NHLBI) grant; National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) and Natural Sciences and Engineering Research Council of Canada, National Institute of Allergy and Infectious Disease; National Heart Lung and Blood Institute RO1, Schwab Charitable Fund; United Health Group; National Basketball Association (NBA); Millennium Pharmaceuticals (Takeda); Octopharma USA, Inc., and the Mayo Clinic.

Principal Investigators

The study was led by Michel Joyner, MD. Dozens of prominent principal investigators helped lead this study and their names can be accessed at the source

Source: medRxiv

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