Clinical Trial for Assessment of Anti-SARS-CoV-2 Serum for Early Treatment of COVID-19 Cases
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cancer
- Cardiovascular Diseases
- Chemotherapy
- Chronic Obstructive Pulmonary Disease
- COVID-19
- Diabetes Mellitus
- Immunosuppression
- Other Complication of Kidney Transplant
- Renal Disease
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model 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.Masking: Double (Participant, Investigator)Masking Description: Stage C of this study was designed as double-blind to avoid the bias introduction in the efficacy and adverse events evaluation. The clinical care team, the responsible professional for administering the serum and the participant will not know which product under investigation will be administered. Only the pharmacists or nurses responsible for the randomization of the study, separation and blinding of the product under investigation will have access to unblinded information. The allocation of the product under investigation will only be revealed after the completion of the participants' following up and database closing to guarantee a long-term safety evaluation of the product. The sponsor's operational team will also remain blind. If necessary, independent scientists not involved with the clinical or laboratory evaluation of the participants, who analyze the unblinded data of laboratory results.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 receive...
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 .
Tracking Information
- NCT #
- NCT04834089
- Collaborators
- Not Provided
- Investigators
- Study Director: Ricardo Palacios, MD, PhD Butantan Institute
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