Multicenter Randomized Clinical Trial of Convalescent Plasma Therapy Added to Best Available Treatment for COVID-19 in Hospitalized Patients

Hyperimmune convalescent plasma (CP) is commonly used in severe respiratory infections of viral origin, in emergency situations and based on low-quality non-comparative studies. Faced with the SARS-CoV-2 pandemic, we propose to carry out a randomized trial in hospitalized subjects with non-critical forms of COVID-19 with CP vs "standard of care" (according to WHO guidelines), in more than 20 hospitals, in coordination with the transfusion centers and the CNM-ISCIII, which will allow us to analyze with a high level of evidence the efficacy and safety of the treatment, including the risk of lung damage mediated by antibodies and immune response, as well as to evaluate its impact on the evolution of viral load and seroconversion (neutralizing antibodies) of patients, evaluate the feasibility of a model for the identification of donors and CP production for SNS patients, and guide decision-making on CP in COVID-19 at the national and international level.