Summary

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

Description

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.

Official Title

Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19

Details

The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 600 eligible subjects stratified 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.

Keywords

SARS-CoV 2 COVID-19 SARS-CoV-2 convalescent plasma Plasma from a volunteer donor

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥ 18 years of age
  • Competent and capable to provide informed consent
  • Positive RNA test for presence of SARS-CoV-2 in fluid collected by oropharyngeal or nasopharyngeal swab
  • Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F), cough, or other COVID associated symptoms like anosmia
  • ≤ 8 days since the first symptoms of COVID-19
  • ≤ 8 days since first positive SARS-CoV-2 RNA test
  • Able and willing to comply with protocol requirements listed in the informed consent

You CAN'T join if...

  • Hospitalized or expected to be hospitalized within 24 hours of enrollment
  • Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
  • History of prior reactions to transfusion blood products
  • Inability to complete therapy with the study product within 24 hours after enrollment
  • Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (off label like hydroxychloroquine, compassionate use or study trial related)

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
    Professor, Medicine. Authored (or co-authored) 108 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Johns Hopkins University
ID
NCT04373460
Phase
Phase 2
Study Type
Interventional
Last Updated