Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients

NCT ID: NCT04693026

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2021-03-05

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19 Covid-19 ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group B: Remdesivir + Tocilizumab treatment group

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.

Group Type ACTIVE_COMPARATOR

Remdesivir

Intervention Type DRUG

Remdesivir 100 IV Infusion as a lyophilized powder

Tocilizumab

Intervention Type DRUG

Tocilizumab IV Infusion

Group A: Remdesivir + Baricitinib treatment group

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

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

Remdesivir 100 IV Infusion as a lyophilized powder

Baricitinib

Intervention Type DRUG

Baricitinib oral tablet form

Interventions

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Remdesivir

Remdesivir 100 IV Infusion as a lyophilized powder

Intervention Type DRUG

Baricitinib

Baricitinib oral tablet form

Intervention Type DRUG

Tocilizumab

Tocilizumab IV Infusion

Intervention Type DRUG

Other Intervention Names

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Ninavir

Eligibility Criteria

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Inclusion Criteria

Severe COVID-19 patients require hospitalization under HDU/ICU. The SARSCoV-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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First affiliated Hospital Xi'an Jiaoting University

UNKNOWN

Sponsor Role collaborator

M Abdur Rahim Medical College and Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Abu Taiub Mohammed Mohiuddin Chowdhury

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Akter Kamal, MD, PhD

Role: STUDY_DIRECTOR

M Abdur Rahim Medical College and Hospital

Locations

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M. Abdur Rahim Medical College Hospital

Dinajpur, , Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

Role: CONTACT

008801817711079

Akter Kamal, MD, PhD

Role: CONTACT

008801817233991

Facility Contacts

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Akter Kamal, MD, PhD

Role: primary

0088017233991

Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

Role: backup

008801817711079

Other Identifiers

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M.A.R.M.C.D./2020/2637

Identifier Type: -

Identifier Source: org_study_id

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