Status:
COMPLETED
Remdesivir Efficacy In Management Of COVID-19 Patients
Lead Sponsor:
Ain Shams University
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and As...
Detailed Description
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and As...
Eligibility Criteria
Inclusion
- Adult 18 -80 years old Must have laboratory confirmed COVID-19(A patient with laboratory confirmation (Positive RT-PCR) of COVID-19 infection, irrespective of clinical signs and symptoms according to Ain Shams University Hospitals Consensus Statement on Management of Adult COVID-19 Patients.
- 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
- Mild to moderately affected COVID 19 confirmed patients.
- pregnancy, lactation.
- known hepatic failure.
- Patient who is not likely to comply to study procedures.
- Creatine clearance \<30 ml/min.
- Elevated transaminases \> 5 fold ULN.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04853901
Start Date
July 27 2020
End Date
March 1 2021
Last Update
April 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11566