NCT04693026

Brief Summary

This study was designed to evaluate the efficacy of Remdesivir and Baricitinib combination therapy for the treatment of severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to compare the outcome of the "Remdesivir + Baricitinib" combination against "Remdesivir + Tocilizumab" therapy and find the best option for the management of ARDS in COVID-19 patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

December 30, 2020

Last Update Submit

December 31, 2020

Conditions

Covid19Covid-19 ARDS

Keywords

COVID 19Covid-19 ARDSTocilizumabRemdicivirBaricitinib

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mortality Rate

    Following randomization 30 days.

  • Duration of ICU stay

    Following randomization 30 days.

  • Duration total hospital stay

    Following randomization 30 days.

  • Rate of daily Supplemental Oxygen Use

    Following randomization 30 days.

  • Time to Clinical Failure

    Following randomization 30 days.

Study Arms (2)

Group A: Remdesivir + Baricitinib treatment group

EXPERIMENTAL

Remdesivir (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. \+ Baricitinib (oral tablet form): Baricitinib tablets 4 mg/day for 2 to 4weeks

Drug: RemdesivirDrug: Baricitinib

Group B: Remdesivir + Tocilizumab treatment group

ACTIVE COMPARATOR

Remdesivir (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 (Injectable solution): Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart.

Drug: RemdesivirDrug: Tocilizumab

Interventions

RemdesivirDRUG

Remdesivir 100 IV Infusion as a lyophilized powder

Also known as: Ninavir
Group A: Remdesivir + Baricitinib treatment groupGroup B: Remdesivir + Tocilizumab treatment group
BaricitinibDRUG

Baricitinib oral tablet form

Group A: Remdesivir + Baricitinib treatment group
TocilizumabDRUG

Tocilizumab IV Infusion

Group B: Remdesivir + Tocilizumab treatment group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Severe COVID-19 patients require hospitalization under HDU/ICU. The SARSCoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. Abdur Rahim Medical College Hospital

Dinajpur, 5200, Bangladesh

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

remdesivirbaricitinibtocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY CHAIR

  • Akter Kamal, MD, PhD

    M Abdur Rahim Medical College and Hospital

    STUDY DIRECTOR

Central Study Contacts

Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

CONTACT

008801817711079dr_mohiuddinchy@yahoo.com

Akter Kamal, MD, PhD

CONTACT

008801817233991kamalaktar@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

December 30, 2020

First Posted

January 5, 2021

Study Start

September 10, 2020

Primary Completion

February 15, 2021

Study Completion

March 5, 2021

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)