Pilot Study of Convalescent COVID-19 Plasma Transfusion in Severe COVID-19 Patients at a Type A Teaching Hospital in Jamaica

Coronavirus Disease 2019 (COVID-19) can be a severe respiratory illness caused by SARS-CoV2 for which there is no standard treatment in affected persons nor a vaccine to prevent the infection. This condition has and continues to cause significant burden on Health care systems with affected persons needing prolonged stay on ventilators in Intensive Care Units.

Convalescent plasma has been used in the treatment of other life-threatening conditions such as Novel Influenza A (H1N1) pandemic, SARS-COV-1 epidemic and Middle East respiratory syndrome -related Coronavirus (MERS-CoV) epidemic. Since convalescent plasma has been found to be beneficial in some diseases but is not always successful in all conditions in which it has been tried, there is no guarantee of success in this disease, and so it is necessary to conduct this study.

A sample of 30 patients with severe and life threatening COVID-19 disease will participate in phase 2 clinical trials. Convalescent Plasma will be administered to participants fulfilling the criteria due to its proven effect on H1N1 pandemic, SARS-COV-1 and MERS-COV epidemic. Although it has proven beneficial in some diseases, there is no guarantee that it will bring the desired outcome , hence the importance of the clinical trials. The observation will consist of three groups, namely, donor, participants and a control group. These patients must recover from all COVID-19 symptoms.

The participants who fulfill the inclusion criteria will receive convalescent plasma, collected from persons who are more than 21 days post negative viral testing or 28 days post resolution of symptoms. Potential participants will be approached by a research assistant within 24 hours of diagnosis and be told about the study and informed consent obtained only after the participants are identified as meeting the inclusion criteria for either participation as donor or recipient of plasma. If in the case of recipients, the recipients are intubated or otherwise unable to give consent, the recipients proxy will be required to do the same before participation is allowed. Plasma donations will also be solicited on the University of the West Indies (UWI) and University Hospital of the West Indies (UHWI) websites and Mona Messaging platform of UWI as well as social media platforms that will be managed by the UHWI public relations department. In addition, the investigators will also use electronic news media publications to inform interested persons about the study.

A sample of the recipients plasma will be kept for future studies as yet unknown. If any of these are genetic studies, attempts will be made to re-contact the donors to consent to these studies. The duration for this first study will be for one year.