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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corona Virus Disease 19 (Covid19) focused on measuring N-acetylcysteine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Al Assema Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

N-acetylcysteine (NAC)

Control

Arm Description

Patients receiving N-acetylcysteine (NAC)

Patients not receiving N-acetylcysteine (NAC)

Outcomes

Primary Outcome Measures

Change in TNF alfa level from baseline
The mean change in TNF alfa is used to assess NAC efficacy

Secondary Outcome Measures

Change in IL-6 level from baseline
The mean change in IL-6 level is used to assess NAC efficacy
Change in glutathione peroxidase level from baseline
The mean change in glutathione peroxidase is used to assess NAC efficacy
Length of hospital stay
Duration of hospital stay for admitted patients
Need for mechanical ventilation
Whether a patient required mechanical ventilation (intubation) or not

Full Information

First Posted
March 7, 2021
Last Updated
April 25, 2022
Sponsor
Ain Shams University
Collaborators
Misr International University
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1. Study Identification

Unique Protocol Identification Number
NCT04792021
Brief Title
Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients
Official Title
Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Misr International University

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Disease 19 (Covid19), Corona Virus Infection, Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)
Keywords
N-acetylcysteine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine (NAC)
Arm Type
Active Comparator
Arm Description
Patients receiving N-acetylcysteine (NAC)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients not receiving N-acetylcysteine (NAC)
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
Acetylcysteine
Intervention Description
Oral formulation: 600 mg sachets of N-acetylcysteine
Primary Outcome Measure Information:
Title
Change in TNF alfa level from baseline
Description
The mean change in TNF alfa is used to assess NAC efficacy
Time Frame
from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Secondary Outcome Measure Information:
Title
Change in IL-6 level from baseline
Description
The mean change in IL-6 level is used to assess NAC efficacy
Time Frame
from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Title
Change in glutathione peroxidase level from baseline
Description
The mean change in glutathione peroxidase is used to assess NAC efficacy
Time Frame
from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Title
Length of hospital stay
Description
Duration of hospital stay for admitted patients
Time Frame
Through study completion ( average 9 months)
Title
Need for mechanical ventilation
Description
Whether a patient required mechanical ventilation (intubation) or not
Time Frame
Through study completion ( average 9 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara M. Sherkawy, B.S.P
Organizational Affiliation
Misr International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lamia El Wakeel, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mona Schaalan, Professor
Organizational Affiliation
Misr International University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayman Moharram, Professor
Organizational Affiliation
El Kasr El Einy Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Al Assema Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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