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

Phase 1

• Conditions: COVID19
• Interventions: Biological: Convalescent Plasma; Drug: Standard of Care

• Registration Number: NCT04438694
• Lead Sponsor: Cairo University

Brief 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).

Detailed Description

This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process .

The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-29
• Primary Completion: 2021-05-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STANDARD CP DOSE Adm (Two infusions)	Convalescent Plasma	Two infusions 48 hours apart
STANDARD CP DOSE Adm (Two infusions)	Standard of Care	Two infusions 48 hours apart
STANDARD OF COARE	Standard of Care	Receiving SOC

Primary Outcome Measures

Name	Time	Method
Duration of hospitalization/Recovery status	2-3 weeks	Decrease of hospital days of safety until discharge

Trial Locations

Locations (1)

Cairo University Hospital; 🇪🇬 Cairo, Egypt