Efficacy and Safety of Sirolimus in COVID-19 Infection

• Status: Recruiting
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandria University
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• Adults (˃18 years) COVID-19 positive patients (confirmed by PCR).

• Moderate infection ( pneumonia ± leucopenia or lymphopenia ).

Exclusion Criteria:

• Severe or life threatening COVID infection: Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours. Life threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure .

• Pregnant or lactating females.

• Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.

• Allergy or hypersensitivity to sirolimus.

• Taking immunosuppressive drugs.

• Glomerular filtration rate (GFR) < 30 ml/min by CKD-EPI equation.

• liver cirrhosis .

• Decompensated heart failure.

• known active tuberculosis (TB) or history of incompletely treated TB.

• Uncontrolled systemic bacterial or fungal infections.

• Drugs that may affect sirolimus level: antifungals, diltiazem, verapamil, nicardipine, phenytoin, phenobarbital, rifampicin, carbamazepine.