Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
511 participants
INTERVENTIONAL
2020-08-11
2021-03-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Convalescent Plasma
Participants receive 1 unit of convalescent plasma.
Convalescent Plasma
SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.
Placebo
Participants receive 1 unit of saline with multivitamin.
Saline
Saline with multivitamin administered via intravenous (IV) infusion..
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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..
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Strategies to Innovate EmeRgENcy Care Clinical Trials Network
NETWORK
University of Pittsburgh
OTHER
Medical University of South Carolina
OTHER
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clifton W Callaway, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Valerie Durkalski-Mauldin, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Frederick Korley, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Sharon Yeatts, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Robert Silbergleit, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
William Barsan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Kevin Schulman, MD
Role: STUDY_DIRECTOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chandler Regional Medical Center
Chandler, Arizona, United States
Valleywise Health Medical Center
Phoenix, Arizona, United States
UCSD Health La Jolla
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Stanford University
Stanford, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, 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
Spectrum Health Hospitals Butterworth Hospital
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital-Troy
Troy, Michigan, United States
HealthPartners Methodist Hospital
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
William P. Clements Jr. University Hospital
Dallas, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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, Greineder CF, Haas NL, Beiser DG, Silbergleit R, Barsan W, Callaway CW; SIREN-C3PO Investigators. Early Convalescent Plasma for High-Risk Outpatients with Covid-19. N Engl J Med. 2021 Nov 18;385(21):1951-1960. doi: 10.1056/NEJMoa2103784. Epub 2021 Aug 18.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Individual Participant Data Set
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
Statistical Design and Analysis Plan for Sequential Parallel-Group RCT for COVID-19 (Harrell and Lindsell, 2020)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C3PO
Identifier Type: -
Identifier Source: org_study_id