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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID; Infectious Disease	Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP); Biological: Standard Plasma (FFP)	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: April 30, 2020
• Actual Primary Completion Date: April 1, 2021
• Actual Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Months and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

• Principal Investigator: Richard Kaufman, MD; Brigham and Women's Hospital

More Information

• Responsible Party: Kaufman, Richard Max,M.D., Principal Investigator, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT04361253
• Other Study ID Numbers: 2020P001215
• First Posted: April 24, 2020
• Last Update Posted: August 13, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• 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; Statistical Analysis Plan (SAP); 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.

• 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

Additional relevant MeSH terms:

Communicable Diseases; Infections; Disease Attributes; Pathologic Processes