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

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; Covid-19 ARDS
• Intervention / Treatment: Drug: Remdesivir; Drug: Baricitinib; Drug: Tocilizumab

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bangladesh
  • Dinajpur, Bangladesh, 5200
    • Recruiting
    • M. Abdur Rahim Medical College Hospital
    • Contact: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD; Phone Number: 008801817711079; Email: dr_mohiuddinchy@yahoo.com
    • Contact: Akter Kamal, MD, PhD; Phone Number: 0088017233991; Email: kamalaktar@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Ninavir; 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: Ninavir; Drug: Tocilizumab; Tocilizumab IV Infusion

What is the study measuring?

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.
Rate of daily Supplemental Oxygen Use	Rate of daily Supplemental Oxygen Use by the patient	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.
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.

Collaborators and Investigators

• Sponsor: M Abdur Rahim Medical College and Hospital
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Anticipated): February 15, 2021
• Study Completion (Anticipated): March 5, 2021

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: COVID 19; Tocilizumab; Baricitinib; Covid-19 ARDS; Remdicivir
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Remdesivir
• Other Study ID Numbers: M.A.R.M.C.D./2020/2637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No