Expanded Access to Convalescent Plasma for Treatment of COVID-19

• Conditions: COVID-19

• Registration Number: NCT04472572
• Lead Sponsor: Hackensack Meridian Health

Brief Summary

This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.

Detailed Description

This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following enrollment on the protocol and provision of informed consent, patients will be transfused with approximately 200-500 mL of ABO compatible convalescent plasma obtained from individuals who have recovered from documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2 titers. Safety information collected will include serious adverse events judged to be related to the administration of convalescent plasma. Other information to be collected retrospectively will include patient demographics, resource utilization (total length of stay, days in ICU, days intubated, and survival to discharge from the facility.

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age at least 18 years

2. Laboratory confirmed diagnosis of infection with SARS-CoV-2

3. Admitted to the hospital for the treatment of COVID-19 complications

4. Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease

5. Informed consent provided by the patient or healthcare proxy

6. Severe COVID-19 is defined by one or more of the following:

   • dyspnea
   • respiratory frequency ≥ 30/min
   • blood oxygen saturation ≤ 93%
   • partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
   • lung infiltrates > 50% within 24 to 48 hours

Life-threatening COVID-19 is defined as one or more of the following:

• respiratory failure/mechanical ventilation
• septic shock
• multiple organ dysfunction or failure

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States