Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ≥ 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

Exclusion Criteria

  • 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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SARS-CoV-2 convalescent plasma
SARS-CoV-2 convalescent plasma (1 cup; ~200-250 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
  • Biological: SARS-CoV-2 convalescent plasma
    Plasma collected by apheresis from a volunteer donor who has recovered from COVID-19 and who has SARS-CoV-2 antibody (titer ≥ 1:320 or current FDA standard titer)
    Other names:
    • Human coronavirus immune plasma (HCIP)
Active Comparator
Standard Control plasma
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.
  • Biological: Plasma from a volunteer donor
    Plasma collected from a volunteer donor prior to December 31, 2019

Recruiting Locations

University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Mary Ayad
713-704-5198
mary.ayad@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

David J Sullivan, MD
410-502-2522
dsulliv7@jhmi.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.