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Convalescent Plasma to Stem Coronavirus (CSSC-001)

Johns Hopkins University logo

Johns Hopkins University

Status and phase

Completed
Phase 2

Conditions

Convalescence
Coronavirus

Treatments

Biological: Anti- SARS-CoV-2 Plasma
Biological: SARS-CoV-2 non-immune Plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04323800
IRB00245634

Details and patient eligibility

About

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.

Full description

This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  1. Subjects must be 18 years of age or older
  2. Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within 96 hours of randomization (and 120 hours of receipt of plasma)

Exclusion Criteria

  1. Receipt of any blood product in past 120 days.
  2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
  3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening.
  4. Laboratory evidence of COVID-19 infection at time of screening.
  5. History or known laboratory evidence of previous COVID-19 infection.
  6. History of prior reactions to transfusion blood products.
  7. Inability to complete therapy with the study product within 24 hours after randomization.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

180 participants in 2 patient groups

High titer anti-SARS-CoV-2 plasma
Experimental group
Description:
Participants with High titer anti-SARS-CoV-2 plasma.
Treatment:
Biological: Anti- SARS-CoV-2 Plasma
SARS-CoV-2 non-immune plasma
Active Comparator group
Description:
Participants with SARS-CoV-2 non-immune plasma.
Treatment:
Biological: SARS-CoV-2 non-immune Plasma

Trial documents
3

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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