Remdesivir Efficacy In Management Of COVID-19 Patients
Study Details
Study Description
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 Assiut University ) assigned hospitals for isolation.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
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 Assiut University ) assigned hospitals for isolation.
The included patients receive. Intervention group: Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days Control group: standard of care without Remdesivir
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Remdesivir Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days |
Drug: Remdesivir
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
Other Names:
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Active Comparator: Standard of care therapy Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days |
Drug: Standard of care_1
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
Other Names:
Drug: Standard of care_2
Methylprednisolone 1-2mg/kg for 5-7 days
Other Names:
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Outcome Measures
Primary Outcome Measures
- Evaluation of viral clearance [14 days]
Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart
Eligibility Criteria
Criteria
Inclusion Criteria:
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,
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Severe disease is defined as:
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Dyspnea,
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Respiratory frequency ≥ 30/min,
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Blood oxygen saturation ≤ 93%,
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Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
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Life-threatening disease is defined as:
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respiratory failure,
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septic shock, and/or
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multiple organ dysfunction or failure
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Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
Exclusion Criteria:
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Mild to moderately affected COVID 19 confirmed patients.
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pregnancy, lactation.
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known hepatic failure.
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Patient who is not likely to comply to study procedures.
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Creatine clearance <30 ml/min.
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Elevated transaminases > 5 fold ULN.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center | Cairo | Non-US | Egypt | 11566 |
Sponsors and Collaborators
- Ain Shams University
Investigators
- Principal Investigator: Hany E Dabbous, M.D, Faculty of Medicine Ain Shams University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FMASU P56a/ 2020