Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients

Phase 2

Completed

Brief Summary: This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

Detailed Description: This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.

Recruitment & Eligibility

Inclusion Criteria

Age ≥ 18 years or older
Hospitalized as an in-patient with positive COVID-19 test by PCR
Presence of respiratory symptoms with any of severe features as below:
- Respiratory Rate ≥ 24/min
- Oxygen Support >3L/min by nasal cannula
- New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
Patient / HCPOA must agree to storage of blood specimens for future testing.
Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.

Exclusion Criteria

FCBP with positive pregnancy test (mandatory)
Breastfeeding females
Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
Mechanical ventilation for > 14 days
Days from symptom onset >21 days
Expected survival < 72 hours
Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .

Arm && Interventions

Group	Intervention	Description
ICU Cohort	anti-SARS-CoV-2 convalescent plasma	Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
Non-ICU Cohort	anti-SARS-CoV-2 convalescent plasma	Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.

Primary Outcome Measures

Name	Time	Method
Overall Mortality	Duration of patient hospitalization, sometimes exceeding 60 days	Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion.

Secondary Outcome Measures

Name	Time	Method
Length of Admission After Plasma Infusion	Length of admission for COVID through study follow-up period	Length of admission after convalescent plasma infusion for all patients. All enrolled patients, whether they were in the ICU cohort or in the non-ICU cohort, were monitored from the time of consent until the time of hospital discharge. Hospital discharge includes those patients who left the hospital alive and those patients who died during their stay.
Length of ICU Stay After Convalescent Plasma Infusion	Length of admission in the ICU for COVID through study follow-up period	Length of ICU stay after plasma infusion for patients who were in the experimental ICU cohort