Inflammatory Regulation Effect of NAC on COVID-19 Treatment

Phase 3

• Conditions: COVID-19
• Interventions: Drug: N-Acetyl cysteine; Drug: Placebo

• Registration Number: NCT04455243
• Lead Sponsor: Dr. Tariq Alhawassi

Brief Summary

Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Last Update Submitted: 2020-07-19
• Last Update Posted: 2020-07-21
• Study Start: 2020-08-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1180

Inclusion Criteria

• Adult above 18 years of age
• Admitted to the hospital With confirmed COVID-19 by RT-PCR test
• On oxygen supplement

Exclusion Criteria

• Active use of NAC
• Known NAC allergy
• In the opinion of the treating team, progression of death is imminent and inevitable within the next 24 hour, irrespective of provision treatment
• All patients enrolled in any other investigational drug studies in COVID-19.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	N-Acetyl cysteine	-
Control group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to Recovery	28 days	Day of recovery is defined as the first day on which of the following three categories from The Ordinal Scale on Covid-19 Clinical Improvement; 1. Not-Hospitalized, No limitation on activity.; 2. Not Hospitalized, with limitation on activity.; 3. Hospitalized, Not requiring supplemental Oxygen