- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792021
Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients
Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections
Study Overview
Status
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:
- Markers of inflammation and oxidative stress
- Length of hospital stay
- Need for ventilation
- Mortality rate
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Al Assema Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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)
|
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Active Comparator: N-acetylcysteine (NAC)
Patients receiving N-acetylcysteine (NAC)
|
Oral formulation: 600 mg sachets of N-acetylcysteine
Other Names:
|
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
Sponsor
Collaborators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Severe Acute Respiratory Syndrome
- COVID-19
- Coronavirus Infections
- Infections
- Virus Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- N-acetylcysteine in COVID 19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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