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Convalescent Plasma in Outpatients With COVID-19 (C3PO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355767
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2020
Last Update Posted : August 6, 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

Tracking Information
First Submitted Date  ICMJE April 17, 2020
First Posted Date  ICMJE April 21, 2020
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE July 31, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2020)
Time to disease progression [ Time Frame: 15 days ]
Progression of disease is defined as any of the following:
  • Patient admitted to the hospital
  • Patient seen in the emergency room (return visit after visit when enrollment takes place)
  • Patient reports increased symptoms of 2 levels on the COVID Outpatient Ordinal Outcomes Scale over a 24 hour period
  • Patient reports increased symptoms of 1 level on the COVID Outpatient Ordinal Outcomes Scale 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 rates 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 of breath)
  5. Patient in their usual state of health
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
  • 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)
  • 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
  • Number of Hospital-free days during the 30 days following randomization [ Time Frame: 30 days ]
  • All-cause mortality [ Time Frame: Assessed at 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2020)
Change in symptom severity over time [ Time Frame: 15 days ]
Categorical change in symptom severity rated on the 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 rates 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 of breath)
  5. Patient in their usual state of health
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convalescent Plasma in Outpatients With COVID-19
Official Title  ICMJE Clinical-trial of COVID-19 Convalescent Plasma in Outpatients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: Convalescent Plasma
    SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.
  • Biological: Saline
    Saline with multivitamin administered via intravenous (IV) infusion..
Study Arms  ICMJE
  • Experimental: Convalescent Plasma
    Participants receive 1 unit of convalescent plasma.
    Intervention: Biological: Convalescent Plasma
  • Placebo Comparator: Placebo
    Participants receive 1 unit of saline with multivitamin.
    Intervention: Biological: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 24, 2020)
600
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2020)
206
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04355767
Other Study ID Numbers  ICMJE C3PO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data (IPD).
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
Investigators  ICMJE
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
Study Director: Kevin Schulman, MD Stanford University
PRS Account Stanford University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP