Remdesivir Efficacy In Management Of COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Remdesivir Efficacy In Management Of COVID-19 Patients

Conditions
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Covid19

Intervention / Treatment
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* Drug: Remdesivir
* Drug: Standard of care_1
* Drug: Standard of care_2


Participation Criteria
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Eligibility Criteria
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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, 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remdesivir<br>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<br>* Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days<br>* Other names: Veklury;|
| Active Comparator: Standard of care therapy<br>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<br>* Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days<br>* Other names: Plaquenil;Drug: Standard of care_2<br>* Methylprednisolone 1-2mg/kg for 5-7 days<br>* Other names: Steroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of viral clearance | Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart | 14 days |