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Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy ((ESCAPE))

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: NCT04361253
Recruitment Status : Terminated (Futility)
First Posted : April 24, 2020
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Kaufman, Richard Max,M.D., Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE April 23, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date August 13, 2021
Actual Study Start Date  ICMJE April 30, 2020
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
Modified WHO Ordinal Scale (MOS) score [ Time Frame: Day 14 ]
The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy
Official Title  ICMJE A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity
Brief Summary In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.
Detailed Description Investigators are doing this research to learn more about high-titer COVID-19 convalescent plasma (HT-CCP) transfusion as a possible treatment for people who have COVID-19, the coronavirus infection. "HT-CCP" is plasma that contains a high amount of antibodies that were made to fight off COVID-19 because it is donated by another person who has also been infected with coronavirus but has recovered, so their immune system has had enough time to make these antibodies. This study is being done to determine whether HT-CCP will help people with COVID-19 recover from their infection more quickly and lower their risk of having to go on a ventilator or reduce the time they need to stay on a ventilator. It is not yet known whether HT-CCP helps people with COVID-19, which is why the study needs to be randomized, meaning some subjects will be randomly selected to receive HT-CCP while others will be randomly selected to receive FFP.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID
  • Infectious Disease
Intervention  ICMJE
  • Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP)
    250mL HT-CCP x2 doses given sequentially.
  • Biological: Standard Plasma (FFP)
    250mL FFP or FP24 x2 doses given sequentially.
Study Arms  ICMJE
  • Experimental: Arm A
    Two units of apheresis HT-CCP, collected from the same donor whenever possible, will be administered sequentially over no greater than a 24-hour period to participants randomized to Arm A. Each unit of HT-CCP will be approximately 250 mL, for a total transfused volume of approximately 500 mL.
    Intervention: Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP)
  • Placebo Comparator: Arm B
    Two units of FFP or FP24 (each 200-275 mL, approximately 500 mL total) will be administered sequentially to participants randomized to Arm B. (FFP/FP24 unit volumes vary more than apheresis plasma units. Two FFP/FP24 units that are approximately 250 mL apiece will be provided.)
    Intervention: Biological: Standard Plasma (FFP)
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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 9, 2021)
45
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2020)
220
Actual Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age >1 year.
  2. Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
  3. Meets institutional criteria for admission to hospital for COVID-19.
  4. Admitted to ICU or non-ICU floor within 5 days of enrollment.
  5. PaO2/FiO2 >200 mmHg if intubated.
  6. Patient or LAR able to provide informed consent.

Exclusion Criteria:

  1. Previous treatment with convalescent plasma for COVID-19.
  2. Current use of investigational antiviral therapy targeting SARS-CoV-2.
  3. History of anaphylactic transfusion reaction.
  4. Clinical diagnosis of acute decompensated heart failure.
  5. Objection to blood transfusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months and older   (Child, 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 NCT04361253
Other Study ID Numbers  ICMJE 2020P001215
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Beginning 3 months after study publication. No end date.
Access Criteria: Proposals should be submitted to rmkaufman@bwh.harvard.edu.
Current Responsible Party Kaufman, Richard Max,M.D., Brigham and Women's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Brigham and Women's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Kaufman, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date August 2021

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