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Convalescent Plasma to Stem Coronavirus (CSSC-001)

NCT04323800 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-04-26

Study results available
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Summary

Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

Conditions

  • Coronavirus
  • Convalescence

Interventions

BIOLOGICAL

Anti- SARS-CoV-2 Plasma

SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320

BIOLOGICAL

SARS-CoV-2 non-immune Plasma

Normal human plasma collected prior to December 2019

Sponsors & Collaborators

Principal Investigators

  • Shmuel Shoham, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2021-04-22
Completion
2021-06-22
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 NCT04323800 on ClinicalTrials.gov