Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients
- Conditions
- Corona Virus Disease 19 (Covid19)Corona Virus InfectionSevere Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)
- Interventions
- Registration Number
- NCT04792021
- Lead Sponsor
- Ain Shams University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Adults aged more than 18 years
- Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included
- Known allergy or hypersensitivity to NAC
- Pregnancy
- Critically ill or mechanically ventilated patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description N-acetylcysteine (NAC) N-acetylcysteine Patients receiving N-acetylcysteine (NAC)
- Primary Outcome Measures
Name Time Method Change in TNF alfa level from baseline 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 Outcome Measures
Name Time Method Length of hospital stay Through study completion ( average 9 months) Duration of hospital stay for admitted patients
Need for mechanical ventilation Through study completion ( average 9 months) Whether a patient required mechanical ventilation (intubation) or not
Change in IL-6 level from baseline from enrollment till the end of treatment at 2 weeks or until hospital discharge or death The mean change in IL-6 level is used to assess NAC efficacy
Change in glutathione peroxidase level from baseline from enrollment till the end of treatment at 2 weeks or until hospital discharge or death The mean change in glutathione peroxidase is used to assess NAC efficacy
Trial Locations
- Locations (1)
Al Assema Hospital
🇪🇬Cairo, Egypt