* This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. * Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. * Subjects will be randomized to receiving convalescent plasma or best supportive care. * Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. * The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
Overall study design * This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. * Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. * Subjects will be randomized to receiving convalescent plasma or best supportive care. * Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. * The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study. A total of 306 subjects will be recruited, 153 for each arm. If a patient in the best supportive care arm requires hospitalization, the patient will be eligible to receive convalescent plasma if requested and/or deemed medically appropriate by the admitting physician. Overall study duration * The study begins when the first subject (donor or recipient) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient). * The expected duration of the study is approximately 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Hackensack University Medical Center
Hackensack, New Jersey, United States
Hospitalization Rate
The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
Time frame: 10 Days
Time to Symptoms Resolution
The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, or lost follow-up on the designed follow-up date, will be censored on that date.
Time frame: 2 Months
Overall Survival Rate
Overall survival (OS) will be defined as Rate of death
Time frame: 2 Months
Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks
Time frame: 2 Weeks
Rate of Nasopharyngeal Swab Positivity in Donors
Time frame: 2 Months
Rate of Donor Titers Level
Rate of Donor Titer Levels \>1:1000
Time frame: 2 Months
Impact of Donor Titers Level on Efficacy
Time frame: 2 Months
Patients' Anti-SARS-CoV2 Titer Assessment Pre-infusion for the Treatment Group, at 2 Weeks , 4 Weeks and 2 Months.
Time frame: Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months
Rate of Virologic Clearance by Nasopharyngeal Swab at 4 Weeks
Time frame: 4 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.