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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remdesivir | Experimental | 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 |
|
| Standard of care therapy | Active Comparator | Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of viral clearance | Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart | 14 days |
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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:
Life-threatening disease is defined as:
Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hany E Dabbous, M.D | Faculty of Medicine Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center | Cairo | Non-US | 11566 | Egypt |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000606551 | remdesivir |
| D006886 | Hydroxychloroquine |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Standard of care_1 | Drug | Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days |
|
|
| Standard of care_2 | Drug | Methylprednisolone 1-2mg/kg for 5-7 days |
|
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |