Clinical trial NCT04438694: Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
Official title: Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: COVID19
Keywords: DONOR
RECIPIENT
CONVALESCENT PLASMA
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 67
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Duration of hospitalization/Recovery status
timeFrame: 2-3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospital
Study officials:
References: