Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Ramdicivir and Baricitinib Combination Therapy for the Treatment of COVID 19 ARDS

Conditions
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Covid19, Covid-19 ARDS

Intervention / Treatment
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* Drug: Remdesivir
* Drug: Baricitinib
* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Remdesivir + Baricitinib treatment group<br>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 | Drug: Remdesivir<br>* Remdesivir 100 IV Infusion as a lyophilized powder<br>* Other names: Ninavir;Drug: Baricitinib<br>* Baricitinib oral tablet form<br>|
| Active Comparator: Group B: Remdesivir + Tocilizumab treatment group<br>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. | Drug: Remdesivir<br>* Remdesivir 100 IV Infusion as a lyophilized powder<br>* Other names: Ninavir;Drug: Tocilizumab<br>* Tocilizumab IV Infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 </= 2 Maintained for 24 Hours. | Following randomization 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID 19, Covid-19 ARDS, Tocilizumab, Remdicivir, Baricitinib