Expanded Access to Convalescent Plasma for Treatment of COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19

Interventions

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Convalescent Plasma

Fresh or frozen plasma will be infused one time to patients with COVID-19 infection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No