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

Sponsor
M Abdur Rahim Medical College and Hospital
Study ID
NCT04693026
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remdesivir — DRUG
    Remdesivir 100 IV Infusion as a lyophilized powder
  • Baricitinib — DRUG
    Baricitinib oral tablet form
  • Tocilizumab — DRUG
    Tocilizumab IV Infusion

Study Details

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.

Key Dates

Start date
Sep 10, 2020
Status verified
Dec 2020
Primary completion
Feb 15, 2021
Completion
Mar 5, 2021

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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.

Primary Outcome Measure

Time to Clinical Improvement (TTCI) [ Time Frame: Following randomization 30 days ]

Central Contacts

Related Studies