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

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥ 18 years or older 2. Hospitalized as an in-patient with positive COVID-19 test by PCR 3. 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 4. Patient / HCPOA must agree to storage of blood specimens for future testing. 5. 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. 6. Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.

Exclusion Criteria

  1. FCBP with positive pregnancy test (mandatory) 2. Breastfeeding females 3. Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies . 4. Mechanical ventilation for > 14 days 5. Days from symptom onset >21 days 6. Expected survival < 72 hours 7. Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI 8. 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 .

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ICU Cohort 		Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
  • Biological: anti-SARS-CoV-2 convalescent plasma
    - SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) - Study drug will be administered as a single intravenous infusion
Experimental
Non-ICU Cohort 		Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
  • Biological: anti-SARS-CoV-2 convalescent plasma
    - SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) - Study drug will be administered as a single intravenous infusion

Recruiting Locations

More Details

NCT ID
NCT04354831
Status
Completed
Sponsor
Medical College of Wisconsin

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.