Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections
Overview
- Phase
- Phase 3
- Intervention
- N-acetylcysteine
- Conditions
- Corona Virus Disease 19 (Covid19)
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in TNF alfa level from baseline
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine "NAC" in COVID 19 patients.
Detailed Description
This is a phase 3 trial enrolling subjects with newly diagnosed Corona virus disease 2019 ( COVID-19) infection who are classified as moderate cases and require hospitalization. Patients meeting eligibility criteria will be randomized either to receive oral N-acetylcysteine or not along with the institution treatment protocol . Treatment efficacy will be assessed using certain endpoints as follows: 1. Markers of inflammation and oxidative stress 2. Length of hospital stay 3. Need for ventilation 4. Mortality rate
Investigators
Sara Mohamed Sherkawy
Principal Investigator at the Faculty of pharmacy
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •Adults aged more than 18 years
- •Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included
Exclusion Criteria
- •Known allergy or hypersensitivity to NAC
- •Critically ill or mechanically ventilated patients
Arms & Interventions
N-acetylcysteine (NAC)
Patients receiving N-acetylcysteine (NAC)
Intervention: N-acetylcysteine
Outcomes
Primary Outcomes
Change in TNF alfa level from baseline
Time Frame: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
The mean change in TNF alfa is used to assess NAC efficacy
Secondary Outcomes
- Length of hospital stay(Through study completion ( average 9 months))
- Need for mechanical ventilation(Through study completion ( average 9 months))
- Change in IL-6 level from baseline(from enrollment till the end of treatment at 2 weeks or until hospital discharge or death)
- Change in glutathione peroxidase level from baseline(from enrollment till the end of treatment at 2 weeks or until hospital discharge or death)