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NCT04455243 Clinical Trial

Inflammatory Regulation Effect of NAC on COVID-19 Treatment

COVID-19 Clinical Trial

— INFECT-19  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04455243
Other study ID # E-20-4934
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date August 1, 2020
Est. completion date August 30, 2021

Study information
Verified date July 2020
Source King Saud University
Contact Baian Alabdulbaqi, MD
Phone +966114670011
Email balabdulbaqi@ksu.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1180
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• N-Acetyl cysteine
150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)
• Placebo
Matching placebo administered in the same schedule and volume as NAC

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Dr. Tariq Alhawassi

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Recovery 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
Not-Hospitalized, No limitation on activity.
Not Hospitalized, with limitation on activity.
Hospitalized, Not requiring supplemental Oxygen		 28 days
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