Convalescent plasma for treatment of COVID-19: A randomized controlled trial (Konvalescent plasma för behandling av COVID-19: En randomiserad kontrollerad studie)

Convalescent plasma (CP) therapy has been used for treatment of infectious diseases for over 100 years.  Published data on 27 COVID-19 patients treated with CP report that it is safe and effective but none of the published studies had a randomized controlled trial (RCT) design, including our own phaseI/II trial on CP in Sweden. We will now collect plasma from persons with high levels of neutralizing antibodies against SARS-CoV-2 identified form a large-scale antibody screening study. We will use this CP in an RCT of the effect of CP when given to COVID-19 patients. We have data to show that the presence of SARS-CoV-2 in serum is associated with a very poor prognosis. The suggested mechanism of action of CP is to neutralize virus in the blood and viral clearance is rapidly seen in phaseII CP trials (both ours and from others). The use of viremia as a poor prognosis marker enables early identification of a risk population and initiation of treatment prior to development of severe symptoms. Patients can thus be recruited at normal wards, primarily the department of infectious disease, Danderyd Hospital and the department of geriatrics, Karolinska University Hospital. Participants will receive 200 ml CP daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 7 CP infusions. Our aim is to assess the efficiency of CP for treatment of patients with COVID-19. If successful, the treatment could readily be made available. Infektionsmedicin