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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-09

Study Completion Date

2022-04-01

Brief Summary

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

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Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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N-acetylcysteine (NAC)

Patients receiving N-acetylcysteine (NAC)

Group Type ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type DRUG

Oral formulation: 600 mg sachets of N-acetylcysteine

Control

Patients not receiving N-acetylcysteine (NAC)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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N-acetylcysteine

Oral formulation: 600 mg sachets of N-acetylcysteine

Intervention Type DRUG

Other Intervention Names

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Acetylcysteine

Eligibility Criteria

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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