Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B342- Coronavirus infection, unspecified
Conditions
Interventions
Intervention1: Atorvastatin 40mg: Atorvastatin 40mg/d for 15 days oral route along with standard treatment
Control Intervention1: Standard treatment: Standard treatment
Sponsors
MRU RIMS Ranchi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed case of COVID-19 based on RT-PCR or typical CT chest findings. Mild COVID-19: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test) and who have any of the various upper respiratory tract symptoms (e.g., cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) with or without fever but who do not have shortness of breath or hypoxia. Sp02 on room air more than 93%. OR Moderate COVID-19: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test), who show evidence of lower respiratory disease during clinical assessment or imaging, and who have an oxygen saturation (SpO2) 90 ââ?¬â?? 93% on room air at sea level or respiratory rate of 24-30 per minute. 2. Presentation within 7 days of onset of fever. 3. Age 18 to 75 years 4. Statin naÃ?¯ve patients (should not use statin for regular 15 days in last one year) 5. Previously documented statin intolerance 6. Unable to provide written informed consent form
Exclusion criteria
Exclusion criteria: 1. Age 2. Severe COVID-19 pneumonia: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test), who show evidence of lower respiratory disease during clinical assessment or imaging and who have SpO2 30 breaths/min 3. Patients already on statins for dyslipidemia or cardiovascular disorders 4. Hypersensitivity to statins. 5. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 2.5 times 6. Pregnancy and lactating mothers. 7. Concomitant treatment with the immunosuppressant cyclosporine or hepatitis C antivirals glecaprevir/pibrentasvir/tipranavir/ritonavir.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome proportion of patients progress from mild/moderate to severe during hospitalTimepoint: at two weeks and four weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are the difference between the two group The difference in requirement of invasive/ non-invasive mechanical ventilation Differences in the requirement of HNFC respiratory support Differences in the duration of hospital stay Timepoint: Day 30 | — |
Countries
India
Contacts
Public ContactAmit Kumar
Rajendra Institute of Medical Sciences
Outcome results
None listed