618
Participants
Start Date
May 31, 2021
Primary Completion Date
May 31, 2022
Study Completion Date
May 31, 2022
AntiSARS-CoV-2 Serum
Stage A: 30 kidney transplanted participants (very high risk), where 15 will received 1 vial (5 mL) and 15 will received 2 vials (10 mL) of serum; Stage B: 30 immunocompetent participants with at least 2 risk factors for severe disease (high risk) who will receive the dose selected by stage A; Stage C: 558 participants, of very high risk and high risk, compared with placebo in allocation 2:1.
Placebo
Saline solution Administration Route: Intravenous
Hospital do Rim, São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo
Lead Sponsor
Butantan Institute
OTHER_GOV