Convalescent Plasma in Outpatients With COVID-19

Covid19 Clinical Trial

— C3PO  

Official title:

Clinical-trial of COVID-19 Convalescent Plasma in Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355767
• Other study ID #: C3PO
• Secondary ID: 1OT2HL156812-01
• Status: Completed
• Phase: Phase 3
• Start date: August 11, 2020
• Est. completion date: March 29, 2021

Study information

• Verified date: October 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• Convalescent Plasma
SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of =1:160 administered via intravenous (IV) infusion.
• Saline
Saline with multivitamin administered via intravenous (IV) infusion..

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	University of Michigan University Hospital	Ann Arbor	Michigan
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Illinois Hospital	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	OSU Wexner Medical Center	Columbus	Ohio
United States	William P. Clements Jr. University Hospital	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
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	Duke University Hospital	Durham	North Carolina
United States	UF Health Shands Hospital	Gainesville	Florida
United States	Spectrum Health Hospitals Butterworth Hospital	Grand Rapids	Michigan
United States	Ben Taub General Hospital	Houston	Texas
United States	Memorial Hermann Texas Medical Center	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	UCSD Health La Jolla	La Jolla	California
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Jackson Memorial Hospital	Miami	Florida
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Valleywise Health Medical Center	Phoenix	Arizona
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Oregon Health & Science University Hospital	Portland	Oregon
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	UC Davis Medical Center	Sacramento	California
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	HealthPartners Methodist Hospital	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	University of Utah Healthcare	Salt Lake City	Utah
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Stanford University	Stanford	California
United States	Mercy St. Vincent Medical Center	Toledo	Ohio
United States	Harbor-UCLA Medical Center	Torrance	California
United States	William Beaumont Hospital-Troy	Troy	Michigan
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	Medical University of South Carolina, National Heart, Lung, and Blood Institute (NHLBI), Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network, University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

Korley FK, Durkalski-Mauldin V, Yeatts SD, Schulman K, Davenport RD, Dumont LJ, El Kassar N, Foster LD, Hah JM, Jaiswal S, Kaplan A, Lowell E, McDyer JF, Quinn J, Triulzi DJ, Van Huysen C, Stevenson VLW, Yadav K, Jones CW, Kea B, Burnett A, Reynolds JC, G — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Disease Progression (Intention-to-treat Population)	Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.	15 days
Primary	Number of Patients With Disease Progression (Per-protocol Population)	Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.	15 days
Secondary	Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization	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	30 days
Secondary	Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression	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	15 days
Secondary	Number of Hospital-free Days During the 30 Days Following Randomization		30 days
Secondary	All-cause Mortality		Assessed at 30 days

External Links

•   SIREN Network
•   Statistical Design and Analysis Plan for Sequential Parallel-Group RCT for COVID-19 (Harrell and Lindsell, 2020)