– 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.
Full Title of Study: “Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: April 29, 2021
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.
- Biological: Convalescent Plasma
- Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
- Other: Best Supportive Care
- Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
Arms, Groups and Cohorts
- Experimental: Convalescent Plasma
- Fresh or frozen plasma will be infused one time to patients
- Active Comparator: Best Supportive Care
- Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
Clinical Trial Outcome Measures
- Hospitalization Rate
- Time Frame: 10 Days
- The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
- Time to Symptoms Resolution
- Time Frame: 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
- Time Frame: 2 Months
- Overall survival (OS) will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.
- Rate of Virologic Clearance by Nasopharyngeal Swab at 2 and 4 Weeks
- Time Frame: 2 and 4 Weeks
- Rate of Nasopharyngeal Swab Positivity in Donors
- Time Frame: 2 Months
- Rate of Donor Titers Level
- 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
Participating in This Clinical Trial
Donor Eligibility Criteria:
- Age 18-60 – A history of a positive nasopharyngeal swab for COVID-19 or a history of positive antibody titer test. – At least 14 days from resolution of COVID-19-associated symptoms including fevers. – A negative nasopharyngeal swab (or similar test) for COVID-19 – anti-SARS-CoV2 titers >1:500 – Adequate venous access for apheresis – Meets donor eligibility criteria in accordance to Hackensack University Medical Center (HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at the JTCC, and all regulatory agencies as describes in SOP 800 01. – Required testing of the donor and product must be performed in accordance to FDA regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30) Recipient Eligibility Criteria: – Patient age >30 years old, newly diagnosed with a COVID-19 infection with onset of first symptoms < 96 hours. – And least one other high-risk feature: 1. Age > 65 2. BMI 30 or above 3. Hypertension, defined as SBP above 140 or DBP above 90, or requiring medication for control. 4. Coronary artery disease (history, not ECG changes only) 5. Congestive heart failure 6. Peripheral vascular disease (includes aortic aneurysm >= 6 cm) 7. Cerebrovascular disease (history of CVA or TIA) 8. Dementia 9. Chronic pulmonary disease 10. Liver disease (such as portal hypertension, chronic hepatitis) 11. Diabetes (excludes diet-controlled alone) 12. Moderate or severe renal disease defined as having a GFR < 60 mL/min 13. Cancer (exclude if > 5 year in remission) 14. AIDS (not just HIV positive) Recipient exclusion criteria:
- History of severe transfusion reaction to plasma products – Need for oxygen supplementation – Positive test for COVID-19 antibodies – Chemotherapy-induced neutropenia (ANC < 0.5 x 103/mcL) – Immunosuppressive medications except for prednisone (or steroid equivalent) > 10 mg daily. – Performance status < 50 by KPS – Pneumonia by radiographic evaluation
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Hackensack Meridian Health
- United States Department of Defense
- Provider of Information About this Clinical Study
- Overall Official(s)
- Michele L Donato, MD, Principal Investigator, Hackensack Meridian Health
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