drugset / Trial / NCT04834089

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

NCT04834089 ↗

Phase 1/2 Unknown 618 enrolled Butantan Institute
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2021-05
Primary completion
2022-05
Completion
2022-05

Drugs

EvaluationDrugModalityDoseRoute
Subject AntiSARS-CoV-2 Serum Protein / enzyme biologic 5 ml Intravenous
Subject AntiSARS-CoV-2 Serum Protein / enzyme biologic 10 ml Intravenous