Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients

Study Overview
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Brief Summary
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The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine NAC in COVID 19 patients.

Detailed Description
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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: Markers of inflammation and oxidative stress Length of hospital stay Need for ventilation Mortality rate

Official Title
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Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections

Conditions
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Corona Virus Disease 19 (Covid19), Corona Virus Infection, Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)

Intervention / Treatment
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* Drug: N-acetylcysteine


Participation Criteria
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Eligibility Criteria
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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 Pregnancy Critically ill or mechanically ventilated patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel for the duration of the study. One arm is the intervention arm: those receiving N-acetylcysteine (NAC). One arm is the control group : those not receiving N-acetylcysteine (NAC).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-acetylcysteine (NAC)<br>Patients receiving N-acetylcysteine (NAC) | Drug: N-acetylcysteine<br>* Oral formulation: 600 mg sachets of N-acetylcysteine<br>* Other names: Acetylcysteine;|
| No Intervention: Control<br>Patients not receiving N-acetylcysteine (NAC) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TNF alfa level from baseline | The mean change in TNF alfa is used to assess NAC efficacy | from enrollment till the end of treatment at 2 weeks or until hospital discharge or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IL-6 level from baseline | The mean change in IL-6 level is used to assess NAC efficacy | from enrollment till the end of treatment at 2 weeks or until hospital discharge or death | 
| Change in glutathione peroxidase level from baseline | The mean change in glutathione peroxidase is used to assess NAC efficacy | from enrollment till the end of treatment at 2 weeks or until hospital discharge or death | 
| Length of hospital stay | Duration of hospital stay for admitted patients | Through study completion ( average 9 months) | 
| Need for mechanical ventilation | Whether a patient required mechanical ventilation (intubation) or not | Through study completion ( average 9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-acetylcysteine