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

M Abdur Rahim Medical College and Hospital

Status and phase: Unknown; Phase 3

Conditions: Covid19; Covid-19 ARDS

Treatments: Drug: Remdesivir; Drug: Tocilizumab; Drug: Baricitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04693026

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

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group A: Remdesivir + Baricitinib treatment group

Experimental group

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

Treatment:

Drug: Remdesivir

Drug: Baricitinib

Group B: Remdesivir + Tocilizumab treatment group

Active Comparator group

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

Treatment:

Drug: Tocilizumab

Drug: Remdesivir