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

M Abdur Rahim Medical College and Hospital205 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

205

Conditions

Covid19 Covid-19 ARDS

Interventions

RemdesivirDRUG

Remdesivir 100 IV Infusion as a lyophilized powder

TocilizumabDRUG

Actemra IV Infusion

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (4)

Chattogram General Hospital

Chittagong, Bangladesh

Cox's Bazar 250 Bed District Sadar Hospital

Cox’s Bāzār, Bangladesh

M. Abdur Rahim Medical College Hospital

Dinajpur, Bangladesh

M. Abdur Rahim Medical College Hospital

Dinajpur, Bangladesh

Outcomes

Primary Outcomes

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.