Status:
UNKNOWN
Efficacy and Safety of Sirolimus in COVID-19 Infection
Lead Sponsor:
Alexandria University
Conditions:
COVID 19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Detailed Description
In early December 2019, several pneumonia cases of unknown origin were observed in Wuhan (China). A novel enveloped RNA β coronavirus was isolated and named severe acute respiratory syndrome coronavir...
Eligibility Criteria
Inclusion
- Adults (˃18 years) COVID-19 positive patients (confirmed by PCR).
- Moderate infection ( pneumonia ± leucopenia or lymphopenia ).
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04461340
Start Date
August 15 2020
End Date
November 30 2020
Last Update
September 9 2020
Active Locations (1)
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1
Faculty of Medicine, Alexandria university, Egypt
Alexandria, Egypt, 21526