Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

618

Participants

Timeline

Start Date

May 31, 2021

Primary Completion Date

May 31, 2022

Study Completion Date

May 31, 2022

Conditions
ImmunosuppressionCancerCOVID-19Other Complication of Kidney TransplantChemotherapyRenal DiseaseDiabetes MellitusCardiovascular DiseasesChronic Obstructive Pulmonary Disease
Interventions
BIOLOGICAL

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.

OTHER

Placebo

Saline solution Administration Route: Intravenous

Trial Locations (2)

04038-002

Hospital do Rim, São Paulo

05403-010

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Butantan Institute

OTHER_GOV

NCT04834089 - Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases | Biotech Hunter | Biotech Hunter