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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID19

Intervention / Treatment
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* Biological: Convalescent Plasma
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This study is a prospective, single-institution, single-arm, study using a historical control group for comparison. Open label, 2 arms: SOC and SOC+CP
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STANDARD OF COARE<br>Receiving SOC | Drug: Standard of Care<br>* Standard of Care drugs administered as per Cairo University ICU protocol<br>|
| Experimental: STANDARD CP DOSE Adm (Two infusions)<br>Two infusions 48 hours apart | Biological: Convalescent Plasma<br>* Convalescent Plasma<br>Drug: Standard of Care<br>* Standard of Care drugs administered as per Cairo University ICU protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization/Recovery status | Decrease of hospital days of safety until discharge | 2-3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DONOR, RECIPIENT, CONVALESCENT PLASMA