Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
Don Forthal, MD

Description

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.

Official Title

Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19

Details

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).

Keywords

Coronavirus Convalescence COVID-19 Coronavirus Infections Anti- SARS-CoV-2 Plasma SARS-CoV-2 non-immune Plasma High titer anti-SARS-CoV-2 plasma

Eligibility

You can join if…

Open to people ages 18 years and up

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

2.1 Living in the same household as, being an intimate partner of, or providing care in a non-healthcare setting (such as a home) for a person with symptomatic laboratory-confirmed COVID-19 infection without using recommended precautions for home care and home isolation.

2.2 HCP who have had prolonged close contact with patients with COVID-19 who were not wearing a face mask while HCP nose and mouth were exposed to material potentially infectious with the virus causing COVID-19.

2.3 Being present in the room for procedures that generate aerosols or during which respiratory secretions are likely to be poorly controlled (e.g., cardiopulmonary resuscitation, intubation, extubation, bronchoscopy, nebulizer therapy, sputum induction) on patients with COVID-19 when the healthcare providers' eyes, nose, or mouth were not protected.

You CAN'T join if...

  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 enrollment.

Locations

  • University of California, Irvine Health accepting new patients
    Orange California 92868 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Irvine

  • Don Forthal, MD
    Professor, Medicine. Authored (or co-authored) 106 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Johns Hopkins University
ID
NCT04323800
Phase
Phase 2
Study Type
Interventional
Last Updated