Remdesivir Efficacy In Management Of COVID-19 Patients
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|ClinicalTrials.gov Identifier: NCT04853901|
Recruitment Status : Completed
First Posted : April 22, 2021
Last Update Posted : April 22, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Remdesivir Drug: Standard of care_1 Drug: Standard of care_2||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remdesivir Efficacy In Management Of COVID-19 Patients|
|Actual Study Start Date :||July 27, 2020|
|Actual Primary Completion Date :||January 1, 2021|
|Actual Study Completion Date :||March 1, 2021|
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
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
Other Name: Veklury
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 Name: Plaquenil
Drug: Standard of care_2
Methylprednisolone 1-2mg/kg for 5-7 days
Other Name: Steroid
- Evaluation of viral clearance [ Time Frame: 14 days ]Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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:
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853901
|Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center|
|Cairo, Non-US, Egypt, 11566|
|Principal Investigator:||Hany E Dabbous, M.D||Faculty of Medicine Ain Shams University|
|Responsible Party:||Hany Dabbous, Professor of Tropical Medicine Faculty of Medicine Ain Shams University, Ain Shams University|
|Other Study ID Numbers:||
FMASU P56a/ 2020
|First Posted:||April 22, 2021 Key Record Dates|
|Last Update Posted:||April 22, 2021|
|Last Verified:||April 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action