Skip to main content
OpenTrials
Completed

NCT Number: NCT04792021

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Corona Virus Disease 19 (Covid19) COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2) Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Al Assema Hospital

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Drug

Oral formulation: 600 mg sachets of N-acetylcysteine

Other names: Acetylcysteine

Primary outcomes

  1. 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

  1. Change in IL-6 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 IL-6 level is used to assess NAC efficacy

  2. Change in glutathione peroxidase 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 glutathione peroxidase is used to assess NAC efficacy

  3. Length of hospital stay

    Time frame: Through study completion ( average 9 months)

    Duration of hospital stay for admitted patients

  4. Need for mechanical ventilation

    Time frame: Through study completion ( average 9 months)

    Whether a patient required mechanical ventilation (intubation) or not

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Misr International University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.