Clinical trial NCT04678739: Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial
Official title: Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Covid-19 ARDS
Keywords: COVID 19
Remdesivir
Ticilizumab
COVID-19 ARDS
Lead sponsor: M Abdur Rahim Medical College and Hospital
Sponsor class: OTHER_GOV
Collaborators: name: First Affiliated Hospital Xi'an Jiaotong University
name: Cox's Bazar 250 Bed District Sadar Hospital
name: Chattogram General Hospital
First posted: 2020-12-22
Enrollment: 205
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to Clinical Improvement (TTCI)
timeFrame: Following randomization 30 days.
Secondary outcomes:
measure: Duration of ICU Stay
timeFrame: Following randomization 30 days.
measure: Mortality Rate
timeFrame: Following randomization 30 days.
measure: Time to Recovery
timeFrame: Following randomization 30 days.
measure: Hospital stay
timeFrame: Following randomization 30 days.
measure: Rate of daily Supplemental Oxygen Use
timeFrame: Following randomization 30 days.
measure: Time to Clinical Failure
timeFrame: Following randomization 30 days.
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chattogram General Hospital
city: Cox's Bazar
country: Bangladesh
facility: Cox's Bazar 250 Bed District Sadar Hospital
city: Dinajpur
country: Bangladesh
facility: M. Abdur Rahim Medical College Hospital
city: Dinajpur
country: Bangladesh
facility: M. Abdur Rahim Medical College Hospital
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
role: STUDY_CHAIR
affiliation: M Abdur Rahim Medical College Hospital
name: Akter Kamal, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Mohiuddin Chowdhury ATM, Kamal A, Abbas KU, Talukder S, Karim MR, Ali MA, Nuruzzaman M, Li Y, He S. Efficacy and Outcome of Remdesivir and Tocilizumab Combination Against Dexamethasone for the Treatment of Severe COVID-19: A Randomized Controlled Trial. Front Pharmacol. 2022 Apr 5;13:690726. doi: 10.3389/fphar.2022.690726. eCollection 2022.