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Plasma Therapy of COVID-19 in Severely Ill Patients

NCT04359810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2024-09-19

Study results available
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Summary

This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).

Conditions

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

Non-convalescent Plasma (control plasma)

Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)

Sponsors & Collaborators

  • New York Blood Center

    collaborator OTHER

  • Amazon, Inc.

    collaborator INDUSTRY

  • Max O'Donnell

    lead OTHER

Principal Investigators

  • Max O'Donnell, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-21
Primary Completion
2020-12-30
Completion
2020-12-30
FDA Drug
Yes

Countries

  • United States
  • 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 NCT04359810 on ClinicalTrials.gov