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

Phase 3
Completed
Conditions
Corona Virus Disease 19 (Covid19)
Corona Virus Infection
Severe 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
Inclusion Criteria
  1. Adults aged more than 18 years
  2. Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included
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Exclusion Criteria
  1. Known allergy or hypersensitivity to NAC
  2. Pregnancy
  3. Critically ill or mechanically ventilated patients
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
N-acetylcysteine (NAC)N-acetylcysteinePatients receiving N-acetylcysteine (NAC)
Primary Outcome Measures
NameTimeMethod
Change in TNF alfa level from baselinefrom 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
NameTimeMethod
Length of hospital stayThrough study completion ( average 9 months)

Duration of hospital stay for admitted patients

Need for mechanical ventilationThrough study completion ( average 9 months)

Whether a patient required mechanical ventilation (intubation) or not

Change in IL-6 level from baselinefrom 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 baselinefrom 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

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