NCT04834089

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

Phase I/II Clinical Trial for Dose Escalation and Safety Assessment and Clinical Response of Anti-SARS-CoV-2 Serum Produced by Instituto Butantan

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 618 (estimated)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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 .

Conditions

• Immunosuppression
• Cancer
• COVID-19
• Other Complication of Kidney Transplant
• Chemotherapy
• Renal Disease
• Diabetes Mellitus
• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2021-04-06
• Last updated: 2021-04-08

Locations

2 sites across 1 country: Brazil