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Convalescent Plasma to Limit SARS-CoV-2 Associated Complications

NCT04373460 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1225

Last updated 2023-06-02

Study results available
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Summary

To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.

Conditions

  • SARS-CoV 2

Interventions

BIOLOGICAL

SARS-CoV-2 convalescent plasma

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

BIOLOGICAL

Plasma from a volunteer donor

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.

Sponsors & Collaborators

  • State of Maryland

    collaborator OTHER_GOV

  • Bloomberg Philanthropies

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • David J Sullivan, MD · The Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2022-01-14
Completion
2022-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04373460 on ClinicalTrials.gov