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| Name | Class |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
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This study was designed to evaluate the efficacy of Remdesivir and Baricitinib combination therapy for the treatment of severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to compare the outcome of the "Remdesivir + Baricitinib" combination against "Remdesivir + Tocilizumab" therapy and find the best option for the management of ARDS in COVID-19 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Remdesivir + Baricitinib treatment group | Experimental | Remdesivir (Injectable solution): A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization. + Baricitinib (oral tablet form): Baricitinib tablets 4 mg/day for 2 to 4weeks |
|
| Group B: Remdesivir + Tocilizumab treatment group | Active Comparator | Remdesivir (Injectable solution) A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization. + Tocilizumab (Injectable solution): Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Remdesivir 100 IV Infusion as a lyophilized powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Improvement (TTCI) | Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of \ | Following randomization 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | Mortality Rate on Days during hospitalization | Following randomization 30 days. |
| Duration of ICU stay | Duration of ICU Stay in days. |
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Inclusion Criteria:
Severe COVID-19 patients require hospitalization under HDU/ICU. The SARSCoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
Exclusion Criteria:
Participants with uncontrolled clinical status who were hospitalized from the before. Contraindication / possible drug interaction. Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/ renal/hepatic disease, AIDS, Pulmonary TB, pregnancy, Corpulmonale, and etc.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD | Contact | 008801817711079 | dr_mohiuddinchy@yahoo.com | |
| Akter Kamal, MD, PhD | Contact | 008801817233991 | kamalaktar@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Akter Kamal, MD, PhD | M Abdur Rahim Medical College and Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M. Abdur Rahim Medical College Hospital | Recruiting | Dinajpur | 5200 | Bangladesh |
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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 |
| C000596027 | baricitinib |
| C502936 | tocilizumab |
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| Baricitinib | Drug | Baricitinib oral tablet form |
|
| Tocilizumab | Drug | Tocilizumab IV Infusion |
|
| Following randomization 30 days. |
| Duration total hospital stay | Duration of hospital stay in days. | Following randomization 30 days. |
| Rate of daily Supplemental Oxygen Use | Rate of daily Supplemental Oxygen Use by the patient | Following randomization 30 days. |
| Time to Clinical Failure | Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first) | Following randomization 30 days. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |