High dose statin for mild/moderate COVID-19 patients

Phase 2

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B342- Coronavirus infection, unspecified

• Registration Number: CTRI/2021/07/034827
• Lead Sponsor: MRU RIMS Ranchi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 na�¯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

1.Age < 18 years

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified