Status:
UNKNOWN
Plasma Rich Antibodies From Recovered Patients From COVID19
Lead Sponsor:
Ain Shams University
Conditions:
Coronavirus Disease (COVID-19)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Prospective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-...
Detailed Description
1. Selection of donor according to the eligibility criteria * Full medical history, concurrent medications, demographic data will be obtained. * Complete clinical assessment with special emphas...
Eligibility Criteria
Inclusion
- Adult 18 -80 years old
- Must have laboratory confirmed COVID-19
- 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 Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
Exclusion
- Patient with mild or moderate COVID-19
- Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04348877
Start Date
April 20 2020
End Date
December 1 2020
Last Update
April 20 2020
Active Locations (1)
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1
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11556