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Trial record 1 of 1 for:    NCT04355767
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Convalescent Plasma in Outpatients With COVID-19 (C3PO)

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ClinicalTrials.gov Identifier: NCT04355767
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : June 26, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
Information provided by (Responsible Party):
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 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.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: Convalescent Plasma Biological: Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical-trial of COVID-19 Convalescent Plasma in Outpatients
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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..




Primary Outcome Measures :
  1. Number of patients with disease progression [ Time Frame: 15 days ]
    Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.


Secondary Outcome Measures :
  1. 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.

    • 8 = Death
    • 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy)
    • 6 = Hospitalized, intubated and mechanically ventilated
    • 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula
    • 4 = Hospitalized on supplemental oxygen by mask or nasal prongs
    • 3 = Hospitalized not on supplemental oxygen
    • 2 = Not hospitalized with limitation in activity (continued symptoms)
    • 1 = Not hospitalized without limitation in activity (no symptoms)

  2. Time to disease progression [ Time Frame: 15 days ]

    Time to disease progression 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 ED 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

  3. Number of Hospital-free days during the 30 days following randomization [ Time Frame: 30 days ]
  4. All-cause mortality [ Time Frame: Assessed at 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355767


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
Investigators
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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
Principal Investigator: Robert Silbergleit, MD University of Michigan
Principal Investigator: William Barsan, MD University of Michigan
Additional Information:
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04355767    
Other Study ID Numbers: C3PO
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data (IPD).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No