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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: anti-SARS-CoV-2 convalescent plasma

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.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Admission After Plasma Infusion	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 admission for COVID through study follow-up period
Length of ICU Stay After Convalescent Plasma Infusion	Length of ICU stay after plasma infusion for patients who were in the experimental ICU cohort	Length of admission in the ICU for COVID through study follow-up period

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Froedtert Hospital
• Investigators: Principal Investigator: Mary Beth Graham, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO00037712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No