Convalescent Plasma in Outpatients With COVID-19

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 enroll 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

  • Covid19

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
Completed
Sponsor
Stanford University