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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04361253|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID Infectious Disease||Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP) Biological: Standard Plasma (FFP)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361253
|Contact: Richard Kaufman, MDfirstname.lastname@example.org|
|Contact: Karina Oganezovaemail@example.com|
|Principal Investigator:||Richard Kaufman, MD||Brigham and Women's Hospital|