Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

• This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases.

• This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank.

The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.

An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).

Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University

Criteria

Inclusion Criteria:

• Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation hospital.

• Admitted to acute care facility.

• Must have severe or immediately life-threatening COVID-19:

Severe disease is defined as:

• dyspnea,

• respiratory frequency ≥ 30/min,

• blood oxygen saturation ≤ 93%,

• partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or

• lung infiltrates > 50% within 24 to 48 hours (CT finding)

Life-threatening disease is defined as:

• respiratory failure,

• septic shock, and/or

• multiple organ dysfunction or failure

Exclusion Criteria:

• Pregnancy

• Autoimmune disorder

• Participated in a CP trial in the past 6 months