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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

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

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.

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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

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




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



Information from the National Library of Medicine

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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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354831


Locations
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United States, Wisconsin
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Froedtert Hospital
Investigators
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Principal Investigator: Mary Beth Graham Medical College of Wisconsin
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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    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021

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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:
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Infection