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

• ClinicalTrials.gov Identifier: NCT04354831
• Recruitment Status: Active, not recruiting
• First Posted: April 21, 2020
• Last Update Posted: January 8, 2021
• Sponsor: Medical College of Wisconsin
• Collaborator: Froedtert Hospital
• Information provided by (Responsible Party): Mary Beth Graham, MD, Medical College of Wisconsin

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Biological: anti-SARS-CoV-2 convalescent plasma	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 131 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 11, 2020
• Estimated Primary Completion Date: May 1, 2022
• Estimated Study Completion Date: May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Overall Mortality within 60 days [ Time Frame: sixty days from infusion of plasma ]
   Overall mortality within 60 days

Secondary Outcome Measures :

1. Length of ICU stay during current admission for COVID [ Time Frame: Length of admission for COVID through study follow-up period, an average of 60 days ]
   length of admission for COVID

Eligibility Criteria

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

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 .

Contacts and Locations

Locations

United States, Wisconsin

Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

Froedtert Hospital

Investigators

• Principal Investigator: Mary Beth Graham; Medical College of Wisconsin

More Information

• Responsible Party: Mary Beth Graham, MD, Associate Chief, Professor Infectious Disease, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT04354831
• Other Study ID Numbers: PRO00037712
• First Posted: April 21, 2020
• Last Update Posted: January 8, 2021
• Last Verified: January 2021

• 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

Keywords provided by Mary Beth Graham, MD, Medical College of Wisconsin:

COVID-19

Additional relevant MeSH terms:

Infection