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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19, Covid-19 ARDS

Intervention / Treatment
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* Drug: Remdesivir
* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Remdesivir + Tocilizumab treatment group<br>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. | Drug: Remdesivir<br>* Remdesivir 100 IV Infusion as a lyophilized powder<br>Drug: Tocilizumab<br>* Actemra IV Infusion<br>* Other names: Actemra IV Infusion;|
| No Intervention: Group B: Control group<br>Treatment as given without Remdesivir and Tocilizumab. | |

What is the study measuring?
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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 |
| --- | --- | --- |
| Duration of ICU Stay | Duration of ICU Stay in Days | Following randomization 30 days. | 
| Mortality Rate | Mortality Rate on Days during hospitalization | Following randomization 30 days. | 
| Time to Recovery | Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed | Following randomization 30 days. | 
| Hospital stay | 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) | Following randomization 30 days. | 
| Rate of daily Supplemental Oxygen Use | Rate of daily Supplemental Oxygen Use by the patient | 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 or Withdrawal (whichever occurs first) | Following randomization 30 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID 19, Remdesivir, Ticilizumab, COVID-19 ARDS