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

NCT ID: NCT04354831

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2021-02-10

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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICU Cohort

Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.

Group Type: EXPERIMENTAL

anti-SARS-CoV-2 convalescent plasma

Intervention Type: BIOLOGICAL

• 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

Non-ICU Cohort

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

Group Type: EXPERIMENTAL

anti-SARS-CoV-2 convalescent plasma

Intervention Type: BIOLOGICAL

• 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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Froedtert Hospital

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Mary Beth Graham, MD

Associate Chief, Professor Infectious Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Beth Graham

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Hospital

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO00037712

Identifier Type: -

Identifier Source: org_study_id