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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354831
• Other study ID #: PRO00037712
• Status: Completed
• Phase: Phase 2
• Start date: May 11, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Froedtert Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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