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Status unknownNCT04455243INFECT-19Updated Jul 21, 2020

Inflammatory Regulation Effect of NAC on COVID-19 Treatment

A Phase 3 interventional study of N-Acetyl cysteine and Placebo in COVID-19, sponsored by Dr. Tariq Alhawassi. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by Dr. Tariq Alhawassi · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
1,180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • COVID-19

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Keywords

  • NAC
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 1,180 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Dr. Tariq Alhawassi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,180 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Drug: N-Acetyl cysteine

  • Placebo comparator
    Control group

    Drug: Placebo

Interventions

  • DrugN-Acetyl cysteine

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

    Also known as: NAC

  • DrugPlacebo

    Matching placebo administered in the same schedule and volume as NAC

06

What researchers measure

Primary outcomes

  1. 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 1. Not-Hospitalized, No limitation on activity. 2. Not Hospitalized, with limitation on activity. 3. Hospitalized, Not requiring supplemental Oxygen

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — IPD data will be shared. However, the exact sharing plans on what or when is not yet decided.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04455243
Lead sponsor
Dr. Tariq Alhawassi
Responsible party
Dr. Tariq Alhawassi (Chairman of Clinical Trial Support Unit, King Saud University) — Sponsor-investigator
First posted
Jul 2, 2020
Start date
Aug 1, 2020 (estimated)
Primary completion
Aug 30, 2021 (estimated)
Completion
Aug 30, 2021 (estimated)
Last update
Jul 21, 2020

Study contacts

Baian Alabdulbaqi, MD
Contact
balabdulbaqi@ksu.edu.sa
+966114670011

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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