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

April 25, 2022 updated by: Sara Mohamed Sherkawy, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Al Assema Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  1. Known allergy or hypersensitivity to NAC
  2. Pregnancy
  3. Critically ill or mechanically ventilated patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients not receiving N-acetylcysteine (NAC)
Active Comparator: N-acetylcysteine (NAC)
Patients receiving N-acetylcysteine (NAC)
Drug: N-acetylcysteine
Oral formulation: 600 mg sachets of N-acetylcysteine
Other Names:
  • Acetylcysteine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
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
from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Length of hospital stay
Time Frame: Through study completion ( average 9 months)
Duration of hospital stay for admitted patients
Through study completion ( average 9 months)
Need for mechanical ventilation
Time Frame: Through study completion ( average 9 months)
Whether a patient required mechanical ventilation (intubation) or not
Through study completion ( average 9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Misr International University

Investigators

  • Principal Investigator: Sara M. Sherkawy, B.S.P, Misr International University
  • Study Chair: Lamia El Wakeel, Professor, Ain Shams University
  • Study Director: Mona Schaalan, Professor, Misr International University
  • Study Director: Ayman Moharram, Professor, El Kasr El Einy Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Actual)

September 13, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

March 7, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-acetylcysteine in COVID 19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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