Status:
UNKNOWN
Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
Lead Sponsor:
Cairo University
Conditions:
COVID19
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Autoimmune disorder
- Participated in a CP trial in the past 6 months
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04438694
Start Date
June 1 2020
End Date
December 31 2021
Last Update
September 29 2020
Active Locations (1)
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1
Cairo University Hospital
Cairo, Egypt