Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group A: Remdesivir + Baricitinib treatment group 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
Remdesivir 100 IV Infusion as a lyophilized powder
Other Names:
Drug: Baricitinib
Baricitinib oral tablet form
|
Active Comparator: Group B: Remdesivir + Tocilizumab treatment group 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
Remdesivir 100 IV Infusion as a lyophilized powder
Other Names:
Drug: Tocilizumab
Tocilizumab IV Infusion
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | M. Abdur Rahim Medical College Hospital | Dinajpur | Bangladesh | 5200 |
Sponsors and Collaborators
- M Abdur Rahim Medical College and Hospital
- First affiliated Hospital Xi'an Jiaoting University
Investigators
- Study Chair: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, First Affiliated Hospital Xi'an Jiaotong University
- Study Director: Akter Kamal, MD, PhD, M Abdur Rahim Medical College and Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M.A.R.M.C.D./2020/2637