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

Corona Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792021
• Other study ID #: N-acetylcysteine in COVID 19
• Status: Completed
• Phase: Phase 3
• Start date: March 9, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2022
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Disease 19 (Covid19)
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Infections
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)
• Virus Diseases

Intervention

Drug:
• N-acetylcysteine
Oral formulation: 600 mg sachets of N-acetylcysteine

Locations

Country	Name	City	State
Egypt	Al Assema Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TNF alfa level from baseline	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	Change in IL-6 level from baseline	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
Secondary	Change in glutathione peroxidase level from baseline	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
Secondary	Length of hospital stay	Duration of hospital stay for admitted patients	Through study completion ( average 9 months)
Secondary	Need for mechanical ventilation	Whether a patient required mechanical ventilation (intubation) or not	Through study completion ( average 9 months)