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

Purpose

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.

Conditions

  • COVID
  • Infectious Disease

Eligibility

Eligible Ages
Over 12 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP)
    250mL HT-CCP x2 doses given sequentially.
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.)
  • Biological: Standard Plasma (FFP)
    250mL FFP or FP24 x2 doses given sequentially.

Recruiting Locations

More Details

NCT ID
NCT04361253
Status
Terminated
Sponsor
Brigham and Women's Hospital

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.