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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04792021

Collaborator

Misr International University (Other)

Enrollment

Location

Arms

12.7

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Disease 19 (Covid19) Corona Virus Infection Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)	Drug: N-acetylcysteine	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 9, 2021

Actual Primary Completion Date :

Sep 13, 2021

Actual Study Completion Date :

Apr 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: N-acetylcysteine (NAC)

Patients receiving N-acetylcysteine (NAC)

Drug: N-acetylcysteine

Oral formulation: 600 mg sachets of N-acetylcysteine

Other Names:

Acetylcysteine

No Intervention: Control

Patients not receiving N-acetylcysteine (NAC)

Outcome Measures

Primary Outcome Measures

Change in TNF alfa level from baseline [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 Outcome Measures

Change in IL-6 level from baseline [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
Change in glutathione peroxidase level from baseline [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
Length of hospital stay [Through study completion ( average 9 months)]
Duration of hospital stay for admitted patients
Need for mechanical ventilation [Through study completion ( average 9 months)]
Whether a patient required mechanical ventilation (intubation) or not

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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