Convalescent Plasma in Outpatients With COVID-19 (C3PO)

October 15, 2021 updated by: Stanford University

Clinical-trial of COVID-19 Convalescent Plasma in Outpatients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
511

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center
      • Phoenix, Arizona, United States, 85008
        • Valleywise Health Medical Center
    • California
      • La Jolla, California, United States, 92037
        • UCSD Health La Jolla
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90211
        • Cedars-Sinai Medical Center
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University Of Colorado Hospital
    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health Shands Hospital
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University Of Chicago Medical Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan University Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Harper University Hospital
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital
      • Detroit, Michigan, United States, 48235
        • Sinai-Grace Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospitals Butterworth Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital-Troy
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • HealthPartners Methodist Hospital
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Hospital
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Columbus, Ohio, United States, 43210
        • OSU Wexner Medical Center
      • Toledo, Ohio, United States, 43608
        • Mercy St. Vincent Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
    • Texas
      • Dallas, Texas, United States, 75235
        • William P. Clements Jr. University Hospital
      • Houston, Texas, United States, 77030
        • Memorial Hermann Texas Medical Center
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Healthcare
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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..

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Disease Progression (Intention-to-treat Population)
Time Frame: 15 days
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
15 days
Number of Patients With Disease Progression (Per-protocol Population)
Time Frame: 15 days
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Time Frame: 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
30 days
Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression
Time Frame: 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
15 days
Number of Hospital-free Days During the 30 Days Following Randomization
Time Frame: 30 days
30 days
All-cause Mortality
Time Frame: Assessed at 30 days
Assessed at 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of South Carolina
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clifton W Callaway, MD, PhD, University of Pittsburgh
  • Principal Investigator: Valerie Durkalski-Mauldin, PhD, Medical University of South Carolina
  • Principal Investigator: Frederick Korley, MD, PhD, University of Michigan
  • Principal Investigator: Sharon Yeatts, PhD, Medical University of South Carolina
  • Study Director: Kevin Schulman, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C3PO
  • 1OT2HL156812-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The complete de-identified patient data set will be shared.

IPD Sharing Time Frame

Data will be available indefinitely.

IPD Sharing Access Criteria

Data requests will be managed by National Heart, Lung, and Blood Institute (NHLBI).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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