Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients
- Conditions
- Covid19Covid-19 ARDS
- Interventions
- Registration Number
- NCT04693026
- Lead Sponsor
- M Abdur Rahim Medical College and Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Severe COVID-19 patients require hospitalization under HDU/ICU. The SARSCoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B: Remdesivir + Tocilizumab treatment group Remdesivir 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. Group A: Remdesivir + Baricitinib treatment group Remdesivir 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 A: Remdesivir + Baricitinib treatment group Baricitinib 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 Tocilizumab 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.
- Primary Outcome Measures
Name Time Method Time to Clinical Improvement (TTCI) Following randomization 30 days Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of \</= 2 Maintained for 24 Hours.
- Secondary Outcome Measures
Name Time Method Mortality Rate Following randomization 30 days. Mortality Rate on Days during hospitalization
Duration of ICU stay Following randomization 30 days. Duration of ICU Stay in days.
Duration total hospital stay Following randomization 30 days. Duration of hospital stay in days.
Rate of daily Supplemental Oxygen Use Following randomization 30 days. Rate of daily Supplemental Oxygen Use by the patient
Time to Clinical Failure Following randomization 30 days. 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)
Trial Locations
- Locations (1)
M. Abdur Rahim Medical College Hospital
🇧🇩Dinajpur, Bangladesh