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

• Conditions: COVID19

• Registration Number: NCT04338360
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

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

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (12)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic Health System in Albert Lea; 🇺🇸 Albert Lea, Minnesota, United States

Mayo Clinic Health System in Austin; 🇺🇸 Austin, Minnesota, United States

Mayo Clinic Health System in Cannon Falls; 🇺🇸 Cannon Falls, Minnesota, United States

Mayo Clinic Health System in Red Wing; 🇺🇸 Red Wing, Minnesota, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Health System - Eau Claire; 🇺🇸 Eau Claire, Wisconsin, United States

Mayo Clinic Health System - Franciscan Healthcare; 🇺🇸 La Crosse, Wisconsin, United States

Mayo Clinic Health System in Lake City; 🇺🇸 Lake City, Minnesota, United States

Mayo Clinic Health System in Mankato; 🇺🇸 Mankato, Minnesota, United States

Mayo Clinic Health System in Owatonna; 🇺🇸 Owatonna, Minnesota, United States