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

Phase 3

Terminated

• Conditions: COVID; Infectious Disease
• Interventions: Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP); Biological: Standard Plasma (FFP)

• Registration Number: NCT04361253
• Lead Sponsor: Brigham and Women's Hospital

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 Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Study Start: 2020-04-30
• Primary Completion: 2021-04-01
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	High-Titer COVID-19 Convalescent Plasma (HT-CCP)	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.
Arm B	Standard Plasma (FFP)	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.)

Primary Outcome Measures

Name	Time	Method
Modified WHO Ordinal Scale (MOS) score	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States