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Convalescent Plasma for Early Treatment of COVID-19

NCT04390503 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2024-08-28

Study results available
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Summary

This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment. Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody ("anti-SARS-CoV-2 plasma") or control (albumin 5%). This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease.

Conditions

Interventions

BIOLOGICAL

Convalescent Plasma (anti-SARS-CoV-2 plasma)

Convalescent Plasma that contains antibody titers against SARS-CoV-2.

BIOLOGICAL

Control (albumin 5%)

Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.

Sponsors & Collaborators

  • Andrew Eisenberger

    lead OTHER

Principal Investigators

  • Jessica Justman, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2022-01-06
Completion
2022-01-06
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390503 on ClinicalTrials.gov