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Inflammatory Regulation Effect of NAC on COVID-19 Treatment

Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04455243
Acronym
INFECT-19
Enrollment
1180
Registered
2020-07-02
Start date
2020-08-01
Completion date
2021-08-30
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

NAC

Brief summary

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

Interventions

DRUGN-Acetyl cysteine

150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)

DRUGPlacebo

Matching placebo administered in the same schedule and volume as NAC

Sponsors

Dr. Tariq Alhawassi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to Recovery28 daysDay 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

Contacts

Primary ContactBaian Alabdulbaqi, MD
balabdulbaqi@ksu.edu.sa+966114670011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026