Convalescent Plasma in Outpatients With COVID-19

Phase 3

Completed

• Conditions: Covid19
• Interventions: Biological: Convalescent Plasma; Biological: Saline

• Registration Number: NCT04355767
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Study Start: 2020-08-11
• Primary Completion: 2021-03-29
• Study Completion: 2021-03-29
• Status Verified: 2021-10
• Results First Submitted: 2021-10-13
• Results First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Results First Posted: 2021-10-19
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Convalescent Plasma	Convalescent Plasma	Participants receive 1 unit of convalescent plasma.
Placebo	Saline	Participants receive 1 unit of saline with multivitamin.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Disease Progression (Per-protocol Population)	15 days	Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Number of Patients With Disease Progression (Intention-to-treat Population)	15 days	Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression	15 days	Assessed on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period.; COVID Outpatient Ordinal Outcomes Scale; * 1 = patient requires care in the hospital; * 2 = patient requires care in the emergency department or urgent care; * 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain); * 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness; * 5 = patient in their usual state of health
Number of Hospital-free Days During the 30 Days Following Randomization	30 days
All-cause Mortality	Assessed at 30 days
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization	30 days	This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.; * 1 = Not hospitalized without limitation in activity (no symptoms); * 2 = Not hospitalized with limitation in activity (continued symptoms); * 3 = Hospitalized not on supplemental oxygen; * 4 = Hospitalized on supplemental oxygen by mask or nasal prongs; * 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula; * 6 = Hospitalized, intubated and mechanically ventilated; * 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy); * 8 = Death

Trial Locations

Locations (53)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

University of New Mexico Hospital; 🇺🇸 Albuquerque, New Mexico, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Chandler Regional Medical Center; 🇺🇸 Chandler, Arizona, United States

William P. Clements Jr. University Hospital; 🇺🇸 Dallas, Texas, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Spectrum Health Hospitals Butterworth Hospital; 🇺🇸 Grand Rapids, Michigan, United States

Mercy St. Vincent Medical Center; 🇺🇸 Toledo, Ohio, United States

UF Health Shands Hospital; 🇺🇸 Gainesville, Florida, United States

SUNY Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States

HealthPartners Methodist Hospital; 🇺🇸 Saint Louis Park, Minnesota, United States

William Beaumont Hospital-Troy; 🇺🇸 Troy, Michigan, United States

Newton-Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Illinois Hospital; 🇺🇸 Chicago, Illinois, United States

OSU Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

UPMC Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

UCSD Health La Jolla; 🇺🇸 La Jolla, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States

Memorial Hermann Texas Medical Center; 🇺🇸 Houston, Texas, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Valleywise Health Medical Center; 🇺🇸 Phoenix, Arizona, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States

University of Michigan University Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Detroit Receiving Hospital; 🇺🇸 Detroit, Michigan, United States

Harper University Hospital; 🇺🇸 Detroit, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Sinai-Grace Hospital; 🇺🇸 Detroit, Michigan, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Utah Healthcare; 🇺🇸 Salt Lake City, Utah, United States

Oregon Health & Science University Hospital; 🇺🇸 Portland, Oregon, United States

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States