Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial
- Registration Number
- NCT04678739
- Lead Sponsor
- M Abdur Rahim Medical College and Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
Severe COVID-19 patients require hospitalization under HDU/ICU. The SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Remdesivir + Tocilizumab treatment group Remdesivir 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. Group A: Remdesivir + Tocilizumab treatment group Tocilizumab 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Duration of ICU Stay Following randomization 30 days. Duration of ICU Stay in Days
Mortality Rate Following randomization 30 days. Mortality Rate on Days during hospitalization
Time to Recovery Following randomization 30 days. Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed
Hospital stay Following randomization 30 days. Time from Randomization to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or \</= 4L Supplemental Oxygen)
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 or Withdrawal (whichever occurs first)
Trial Locations
- Locations (3)
Chattogram General Hospital
🇧🇩Chittagong, Bangladesh
Cox's Bazar 250 Bed District Sadar Hospital
🇧🇩Cox's Bazar, Bangladesh
M. Abdur Rahim Medical College Hospital
🇧🇩Dinajpur, Bangladesh