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

NCT04354831 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PRO00037712
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of Admission After Plasma Infusion

  Length of admission for COVID through study follow-up period

• Length of ICU Stay After Convalescent Plasma Infusion

  Length of admission in the ICU for COVID through study follow-up period

Study Arms (2)

ICU Cohort

EXPERIMENTAL

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

Non-ICU Cohort

EXPERIMENTAL

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

Interventions

anti-SARS-CoV-2 convalescent plasma 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

ICU Cohort; Non-ICU Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Froedtert Hospital: collaborator

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Limitations: The plan was to infuse high titer plasma. All units were screened for SARS-CoV-2 antibody and were positive, but our blood bank was not able to provide specific titer information for each unit. We planned to monitor patients for up to 60 days post infusion, but once discharged pandemic concerns prevented follow-up. Caveats: Inpatients were followed for duration of hospitalization, sometimes exceeding 60 days.

Results Point of Contact

• Title: Mary Beth Graham, MD
• Organization: Medical College of Wisconsin

mbgraham@mcw.edu

414-955-0500

Study Officials

• Mary Beth Graham

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief, Professor Infectious Disease

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

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 21, 2020
• Study Start: May 11, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: April 10, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)