Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection

Phase 2

Terminated

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Best Supportive Care	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.
Convalescent Plasma	Convalescent Plasma	Fresh or frozen plasma will be infused one time to patients

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