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| Name | Class |
|---|---|
| Beni-Suef University | OTHER |
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Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.
Aim of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days. |
|
| interventional | Experimental | Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group | Clinical cure will be assessed after 5-7 days from starting treatment based on:
| "through study completion, an average of 3 months" |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of adverse events. | The occurrence of adverse events will be recorded on a daily basis, with a focus on: bacterial or fungal infections, elevation of AST or ALT level > 3x the upper limit of normal range. | "through study completion, an average of 3 months" |
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Inclusion Criteria:
Hospitalized adult patients with pneumonia evidenced by chest CT scan.
Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
And at least one of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed E Abou warda, BSc | Contact | 00201007647696 | ahmed.essam@o6u.edu.eg | |
| Marian Boshra, PhD | Contact | 00201280571448 |
| Name | Affiliation | Role |
|---|---|---|
| Rania M Sarhan, PhD | Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-suef University | Recruiting | Banī Suwayf | 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 |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| D008722 | Methods |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lopinavir/ Ritonavir and Remdesivir combination | Drug | Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days |
|
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D008919 | Investigative Techniques |