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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678739
• Other study ID #: M.A.R.M.C.D./2020/1985
• Status: Completed
• Phase: Phase 3
• Start date: August 15, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: March 2021
• Source: M Abdur Rahim Medical College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: February 10, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19 ARDS
• Covid19

Intervention

Drug:
• Remdesivir
Remdesivir 100 IV Infusion as a lyophilized powder
• Tocilizumab
Actemra IV Infusion

Locations

Country	Name	City	State
Bangladesh	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	M. Abdur Rahim Medical College Hospital	Dinajpur

Sponsors (4)

Lead Sponsor	Collaborator
M Abdur Rahim Medical College and Hospital	Chattogram General Hospital, Cox's Bazar 250 Bed District Sadar Hospital, First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Clinical Improvement (TTCI)	Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of	Following randomization 30 days.
Secondary	Duration of ICU Stay	Duration of ICU Stay in Days	Following randomization 30 days.
Secondary	Mortality Rate	Mortality Rate on Days during hospitalization	Following randomization 30 days.
Secondary	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.
Secondary	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	Following randomization 30 days.
Secondary	Rate of daily Supplemental Oxygen Use	Rate of daily Supplemental Oxygen Use by the patient	Following randomization 30 days.
Secondary	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.