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.
Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP)
250mL HT-CCP x2 doses given sequentially.
Biological: Standard Plasma (FFP)
250mL FFP or FP24 x2 doses given sequentially.
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.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Richard Kaufman, MD, Principal Investigator
Brigham and Women's Hospital