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CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients

NCT04364737 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 941

Last updated 2023-01-26

Study results available
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Summary

This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.

Conditions

  • COVID-19
  • Coronavirus
  • Coronavirus Infection

Interventions

BIOLOGICAL

Convalescent Plasma

SARS-CoV-2 convalescent plasma (1-2 units; \~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate

OTHER

Saline solution

Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Albert Einstein College of Medicine

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • The University of Texas Health Science Center at Tyler

    collaborator OTHER

  • University of Miami

    collaborator OTHER

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Mila B Ortigoza, MD, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2021-03-29
Completion
2022-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04364737 on ClinicalTrials.gov