Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus
COVID-19 Pneumonia
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring COVID-19, baricitinib, remdesivir, dexamethasone, diabetes mellitus, hospitalized
Eligibility Criteria
Inclusion Criteria:
Hospitalized diabetic adults with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) in any respiratory specimen within 10 days prior to randomization or *Hospitalized diabetic adults with typical features of COVID-19 for 10 days prior to randomization, not yet tested for SARS-CoV-2 infection by PCR in any respiratory specimen.
- RT-PCR for SARS-CoV-2 will be performed within 48 hours of enrollment and excluded from the study if found to be negative.
- 8-point ordinal scale "category 5" patients, but O2 requirement not more than 10L / min.
- The subject provides informed consent before initiating any study procedures and understands and agrees to comply with planned study procedures
Exclusion Criteria:
- Patients with evidence (clinical, hematological, microbiological or imaging ) of sepsis or any acute/subacute coinfection at the time of enrollment.
- Patients who have already received any of the study drugs prior to randomization.
- Patients with severe renal and/or hepatic impairment (eGFR <30 mL/min [EPI-CKD formula] or serum ALT more than 5 times normal upper limit, serum bilirubin > 2 mg/dl).
- Patients with known COPD.
- Patients with absolute neutrophil count <700 cells/microliter, 0.7 x 103/microliter.
- Patients with absolute lymphocyte count <200 cells/microliter, 0.20 x 103/microliter.
- Patients who are allergic to any of the study drugs.
- Patients with chronic infections, such as tuberculosis (TB), HIV infection etc.
- Immunosuppressed patients, such as taking cytotoxic/immunomodulating drugs or systemic steroid.
Sites / Locations
- Debidwar Upazila Health ComplexRecruiting
- BIRDEM General HospitalRecruiting
- Mugda Medical College and HospitalRecruiting
- Kurmitola General HospitalRecruiting
- Kurigram Adhunik Sadar HospitalRecruiting
- Rajshahi Medical College & HospitalRecruiting
- Dedicated Corona Isolation Hospital (DCIH)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Remdesivir plus Baricitinib
Remdesivir plus Dexamethasone
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 5-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 5 -day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.