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Clinical Trial Summary

Phase I/II Randomized Clinical Trial to evaluate the safety, pharmacokinetic and efficacy of Anti-SARS-CoV-2 hyperimmune serum. The study will include patients at early stage of COVID-19 with increased risk for severe disease due to underlying medical conditions to determine the utility of an equine heterologous serum anti-SARS-CoV-2 to avoid progression to a severe COVID-19

Clinical Trial Description

Phase I/II Clinical Trial, randomized, multicentric, on three stages (A, B and C) to evaluate the safety, pharmacokinetic and efficacy of Anti-SARS-CoV-2 serum and dose escalation. The study will be in three stages: 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 (endpoint-driven design) Allocation type Open study without allocation of randomization on Stages A and B Randomized allocation with placebo comparator in Stage C. Recruitment Status: On planning Date of 1st recruitment Expected: April 2021 Target sample siz 618 (30/30/538) participants . ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04834089
Study type Interventional
Source Butantan Institute
Contact Ricardo Palacios, MD, PhD
Phone +551137232121
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date May 2021
Completion date May 2022

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