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

Ain Shams University

Status and phase: Completed; Phase 3

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

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT04792021

N-acetylcysteine in COVID 19

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

N-acetylcysteine (NAC)

Active Comparator group

Description:

Patients receiving N-acetylcysteine (NAC)

Treatment:

Drug: N-acetylcysteine

Control

No Intervention group

Description:

Patients not receiving N-acetylcysteine (NAC)