Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

Mayo Clinic

Status

Conditions: COVID19

Treatments: Biological: COVID-19 convalescent plasma

Study type: Expanded Access

Funder types: Other

Identifiers

NCT04338360

20-003312

Details and patient eligibility

About

This expanded access program will provide access to investigational convalescent plasma for patients in acute care facilities 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age at least 18 years
• Laboratory confirmed diagnosis of infection with SARS-CoV-2
• Admitted to an acute care facility for the treatment of COVID-19 complications
• 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
• Informed consent provided by the patient or healthcare proxy

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
• septic shock
• multiple organ dysfunction or failure

Exclusion criteria

• None