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

Primary Purpose

Covid19, Covid-19 ARDS

Status

Unknown status

Phase

Phase 3

Locations

Bangladesh

Study Type

Interventional

Intervention

Remdesivir

Baricitinib

Tocilizumab

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID 19, Covid-19 ARDS, Tocilizumab, Remdicivir, Baricitinib

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

M. Abdur Rahim Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: Remdesivir + Baricitinib treatment group

Group B: Remdesivir + Tocilizumab treatment group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality Rate

Mortality Rate on Days during hospitalization

Duration of ICU stay

Duration of ICU Stay in days.

Duration total hospital stay

Duration of hospital stay in days.

Rate of daily Supplemental Oxygen Use

Rate of daily Supplemental Oxygen Use by the patient

Time to Clinical Failure

Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first)

Full Information

NCT ID

NCT04693026

First Posted

December 30, 2020

Last Updated

December 31, 2020

Sponsor

M Abdur Rahim Medical College and Hospital

Collaborators

First affiliated Hospital Xi'an Jiaoting University

1. Study Identification

Unique Protocol Identification Number

NCT04693026

Brief Title

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

Official Title

Efficacy of Ramdicivir and Baricitinib Combination Therapy for the Treatment of COVID 19 ARDS

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 10, 2020 (Actual)

Primary Completion Date

February 15, 2021 (Anticipated)

Study Completion Date

March 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

M Abdur Rahim Medical College and Hospital

Collaborators

First affiliated Hospital Xi'an Jiaoting University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Covid-19 ARDS

Keywords

COVID 19, Covid-19 ARDS, Tocilizumab, Remdicivir, Baricitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: Remdesivir + Baricitinib treatment group

Arm Type

Experimental

Arm Description

Arm Title

Group B: Remdesivir + Tocilizumab treatment group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Remdesivir

Other Intervention Name(s)

Ninavir

Intervention Description

Remdesivir 100 IV Infusion as a lyophilized powder

Intervention Type

Drug

Intervention Name(s)

Baricitinib

Intervention Description

Baricitinib oral tablet form

Intervention Type

Drug

Intervention Name(s)

Tocilizumab

Intervention Description

Tocilizumab IV Infusion

Primary Outcome Measure Information:

Title

Time to Clinical Improvement (TTCI)

Description

Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of </= 2 Maintained for 24 Hours.

Time Frame

Following randomization 30 days

Secondary Outcome Measure Information:

Title

Mortality Rate

Description

Mortality Rate on Days during hospitalization

Time Frame