Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial

Sponsor
M Abdur Rahim Medical College and Hospital
Study ID
NCT04678739
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Remdesivir — DRUG
    Remdesivir 100 IV Infusion as a lyophilized powder
  • Tocilizumab — DRUG
    Actemra IV Infusion

Study Details

This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.

Key Dates

Start date
Aug 15, 2020
Status verified
Mar 2021
Primary completion
Jan 30, 2021
Completion
Feb 10, 2021

Study Design

Enrollment
205 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Remdesivir + Tocilizumab treatment group
    Drug: Remdesivir Injectable solution Tocilizumab 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 I/V 8mg/Kg up to 800mg highest 12 hours apart.
  • No Intervention: Group B: Control group
    Treatment as given without Remdesivir and Tocilizumab.

Primary Outcome Measure

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

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