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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04693026

Enrollment

150

Registered

2021-01-05

Start date

2020-09-10

Completion date

2021-03-05

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Covid-19 ARDS

Keywords

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

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.

Interventions

DRUGRemdesivir

Remdesivir 100 IV Infusion as a lyophilized powder

DRUGBaricitinib

Baricitinib oral tablet form

DRUGTocilizumab

Tocilizumab IV Infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to Clinical Improvement (TTCI)	Following randomization 30 days	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

Measure	Time frame	Description
Mortality Rate	Following randomization 30 days.	Mortality Rate on Days during hospitalization
Duration of ICU stay	Following randomization 30 days.	Duration of ICU Stay in days.
Duration total hospital stay	Following randomization 30 days.	Duration of hospital stay in days.
Rate of daily Supplemental Oxygen Use	Following randomization 30 days.	Rate of daily Supplemental Oxygen Use by the patient
Time to Clinical Failure	Following randomization 30 days.	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)

Countries

Bangladesh

Contacts

Primary ContactAbu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

dr_mohiuddinchy@yahoo.com008801817711079

Backup ContactAkter Kamal, MD, PhD

kamalaktar@yahoo.com008801817233991

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026