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A Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

anti-SARS-CoV-2 convalescent plasma

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

Froedtert Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ICU Cohort

Non-ICU Cohort

Arm Description

Patients who are in the ICU at the time of enrollment. Patients will receive 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.

Outcomes

Primary Outcome Measures

Overall Mortality within 60 days

Overall mortality within 60 days

Secondary Outcome Measures

Length of ICU stay during current admission for COVID

length of admission for COVID

Full Information

NCT ID

NCT04354831

First Posted

April 14, 2020

Last Updated

August 23, 2022

Sponsor

Medical College of Wisconsin

Collaborators

Froedtert Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04354831

Brief Title

A Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

Official Title

An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

May 11, 2020 (Actual)

Primary Completion Date

February 10, 2021 (Actual)

Study Completion Date

February 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

Collaborators

Froedtert Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ICU Cohort

Arm Type

Experimental

Arm Description

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

Arm Title

Non-ICU Cohort

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

anti-SARS-CoV-2 convalescent plasma

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Mortality within 60 days

Description

Overall mortality within 60 days

Time Frame

sixty days from infusion of plasma

Secondary Outcome Measure Information:

Title

Length of ICU stay during current admission for COVID

Description

length of admission for COVID

Time Frame

Length of admission for COVID through study follow-up period, an average of 60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 .

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Beth Graham

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Froedtert Hospital

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

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