COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56896

Amit Kumar

ganeshchauhan83@gmail.com

2021-07-14

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Diagnosed case of COVID-19 based on RT-PCR or typical CT chest findings. <br/ >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%. <br/ > <br/ >OR <br/ >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 â?? 93% on room air at sea level or respiratory rate of 24-30 per minute. <br/ > <br/ >2. Presentation within 7 days of onset of fever. <br/ > <br/ >3. Age 18 to 75 years <br/ > <br/ >4. Statin naïve patients (should not use statin for regular 15 days in last one year) <br/ > <br/ >5. Previously documented statin intolerance <br/ > <br/ >6. Unable to provide written informed consent form

1. Age < 18 years <br/ > <br/ >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 <90% on room air at sea level or respiratory frequency >30 breaths/min <br/ > <br/ >3. Patients already on statins for dyslipidemia or cardiovascular disorders <br/ > <br/ >4. Hypersensitivity to statins. <br/ > <br/ >5. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 2.5 times <br/ > <br/ >6. Pregnancy and lactating mothers. <br/ > <br/ >7. Concomitant treatment with the immunosuppressant cyclosporine or hepatitis C antivirals glecaprevir/pibrentasvir/tipranavir/ritonavir. <br/ >

2

MRU RIMS Ranchi

18

75

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

616

The primary outcome proportion of patients progress from mild/moderate to severe during hospitalTimepoint: at two weeks and four weeks

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 137, "treatment_name": "Atorvastatin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]