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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04693026
• Other study ID #: M.A.R.M.C.D./2020/2637
• Status: Recruiting
• Phase: Phase 3
• Start date: September 10, 2020
• Est. completion date: March 5, 2021

Study information

• Verified date: December 2020
• Source: M Abdur Rahim Medical College and Hospital
• Contact: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
• Phone: 008801817711079
• Email: dr_mohiuddinchy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 5, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19 ARDS
• Covid19

Intervention

Drug:
• Remdesivir
Remdesivir 100 IV Infusion as a lyophilized powder
• Baricitinib
Baricitinib oral tablet form
• Tocilizumab
Tocilizumab IV Infusion

Locations

Country	Name	City	State
Bangladesh	M. Abdur Rahim Medical College Hospital	Dinajpur

Sponsors (2)

Lead Sponsor	Collaborator
M Abdur Rahim Medical College and Hospital	First affiliated Hospital Xi'an Jiaoting University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Mortality Rate	Mortality Rate on Days during hospitalization	Following randomization 30 days.
Secondary	Duration of ICU stay	Duration of ICU Stay in days.	Following randomization 30 days.
Secondary	Duration total hospital stay	Duration of hospital stay in days.	Following randomization 30 days.
Secondary	Rate of daily Supplemental Oxygen Use	Rate of daily Supplemental Oxygen Use by the patient	Following randomization 30 days.
Secondary	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.