Purpose

The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.

Condition

Eligibility

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

Inclusion Criteria

  • One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection - Has at least one study defined risk factor for severe COVID-19 illness - Clinical team deems stable for outpatient management without supplemental oxygen - CP available at the site at the time of enrollment - Duration of symptoms ≤ 7 days at ED presentation - Informed consent from subject

Exclusion Criteria

  • Age less than 18 years - Prisoner or ward of the state - Presumed unable to complete follow-up assessments - Prior adverse reaction(s) from blood product transfusion - Receipt of any blood product within the past 120 days - Treating clinical team unwilling to administer 300 ml fluid - Enrollment in another interventional trial for COVID-19 illness

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Convalescent Plasma
Participants receive 1 unit of convalescent plasma.
  • Biological: Convalescent Plasma
    SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.
Placebo Comparator
Placebo
Participants receive 1 unit of saline with multivitamin.
  • Biological: Saline
    Saline with multivitamin administered via intravenous (IV) infusion..

Recruiting Locations

More Details

NCT ID
NCT04355767
Status
Enrolling by invitation
Sponsor
Stanford University

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.