A Phase 3 interventional study of Remdesivir and Standard of care_1 in Covid19, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment
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 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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 77 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Life-threatening disease is defined as:
Exclusion Criteria:
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
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 · Drug: Standard of care_2
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
Also known as: Veklury
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
Also known as: Plaquenil
Methylprednisolone 1-2mg/kg for 5-7 days
Also known as: Steroid
Evaluation of viral clearance
Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Ain Shams University