Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
77 participants
INTERVENTIONAL
2020-07-27
2021-03-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Remdesivir
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
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
Standard of care_1
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
Standard of care_2
Methylprednisolone 1-2mg/kg for 5-7 days
Interventions
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Remdesivir
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
Standard of care_1
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
Standard of care_2
Methylprednisolone 1-2mg/kg for 5-7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Hany Dabbous
Professor of Tropical Medicine Faculty of Medicine Ain Shams University
Principal Investigators
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Hany E Dabbous, M.D
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine Ain Shams University
Locations
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Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt
Countries
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Other Identifiers
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FMASU P56a/ 2020
Identifier Type: -
Identifier Source: org_study_id
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