Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection
- Conditions
- COVID-19
- Registration Number
- NCT04456413
- Lead Sponsor
- Hackensack Meridian Health
- Brief Summary
* 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Hospitalization Rate 10 Days The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
- Secondary Outcome Measures
Name Time Method Time to Symptoms Resolution 2 Months 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.
Overall Survival Rate 2 Months Overall survival (OS) will be defined as Rate of death
Rate of Nasopharyngeal Swab Positivity in Donors 2 Months Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks 2 Weeks Rate of Donor Titers Level 2 Months Rate of Donor Titer Levels \>1:1000
Impact of Donor Titers Level on Efficacy 2 Months Patients' Anti-SARS-CoV2 Titer Assessment Pre-infusion for the Treatment Group, at 2 Weeks , 4 Weeks and 2 Months. Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months Rate of Virologic Clearance by Nasopharyngeal Swab at 4 Weeks 4 Weeks
Trial Locations
- Locations (1)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Hackensack University Medical Center🇺🇸Hackensack, New Jersey, United States