Convalescent Plasma in Outpatients With COVID-19 (C3PO)

Stanford University

Status and phase: Completed; Phase 3

Conditions: Covid19

Treatments: Biological: Convalescent Plasma; Biological: Saline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04355767

C3PO

1OT2HL156812-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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511 participants in 2 patient groups, including a placebo group

Convalescent Plasma

Experimental group

Description:

Participants receive 1 unit of convalescent plasma.

Treatment:

Biological: Convalescent Plasma

Placebo

Placebo Comparator group

Description:

Participants receive 1 unit of saline with multivitamin.

Treatment:

Biological: Saline