COVID-19, the disease caused by the SARS-CoV-2 virus, began spreading in late 2019. Global health authorities quickly started tracking and studying the outbreak. By March 11, 2020, the World Health Organization declared a pandemic.
Researchers at Johns Hopkins University responded with two clinical trials of convalescent plasma at study sites across the US. The convalescent plasma used in these trials came from blood donations from individuals who had recovered from COVID-19. This plasma contained antibodies against SARS-CoV-2 and was tested against control plasma that didn’t have those antibodies.
This pair of randomized, controlled, double-blind, phase 2 trials evaluated whether convalescent plasma helped prevent infection or could be used as an effective early treatment option for COVID-19. Results from the early treatment study were published in The New England Journal of Medicine.
BIOS CTCC served as the clinical coordinating center for both studies. These trials were funded principally by the US Department of Defense with additional support from Bloomberg Philanthropies, State of Maryland, the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases, NIH National Center for Advancing Translational Sciences, Mental Wellness Foundation, Moriah Fund, Octapharma, HealthNetwork Foundation, and the Shear Family Foundation. The study sponsors did not contribute to the study design or the collection, analysis, and interpretation of data.
Outpatient COVID-19 Plasma Research Study for Prevention (CSSC-001)
The infection prevention study sought to discover if convalescent plasma could protect someone who had been recently exposed to the SARS-CoV-2 virus—such as a parent caring for a sick child or a health care worker not wearing personal protective equipment—who was not yet sick themselves.
This trial assessed the efficacy and safety of convalescent plasma as a preventive measure following exposure to COVID-19. About 180 adults with a high-risk exposure as defined by the Centers for Disease Control and Prevention were enrolled and randomized to receive either high-titer convalescent plasma or control plasma.
ClinicalTrials.gov Identifier: NCT04323800
Early Outpatient COVID-19 Plasma Treatment Research Study (CSSC-004)
The early treatment study enrolled individuals who had been recently diagnosed with COVID-19 and who had at least one symptom, but had not been admitted to the hospital.
This trial assessed the efficacy and safety of convalescent plasma to reduce the risk of hospitalization or death, the duration of symptoms, and duration of viral shedding through nasal and oral secretions. About 1200 participants were randomized to receive either convalescent or control plasma. Participants were adult outpatients with symptomatic COVID-19 who received plasma within 8 days of symptom onset. Results were published in The New England Journal of Medicine.
ClinicalTrials.gov Identifier: NCT04373460