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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
250mL HT-CCP x2 doses given sequentially.
250mL FFP or FP24 x2 doses given sequentially.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Modified WHO Ordinal Scale (MOS) score
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.
Time frame: Day 14
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