Inflammatory Regulation Effect of NAC on COVID-19 Treatment (INFECT-19)
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ClinicalTrials.gov Identifier: NCT04455243 |
Recruitment Status : Unknown
Verified July 2020 by Dr. Tariq Alhawassi, King Saud University.
Recruitment status was: Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: N-Acetyl cysteine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19 |
Estimated Study Start Date : | August 1, 2020 |
Estimated Primary Completion Date : | August 30, 2021 |
Estimated Study Completion Date : | August 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention group |
Drug: N-Acetyl cysteine
150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)
Other Name: NAC |
Placebo Comparator: Control group |
Drug: Placebo
Matching placebo administered in the same schedule and volume as NAC |
- Time to Recovery [ Time Frame: 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
- Not-Hospitalized, No limitation on activity.
- Not Hospitalized, with limitation on activity.
- Hospitalized, Not requiring supplemental Oxygen

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455243
Contact: Baian Alabdulbaqi, MD | +966114670011 | balabdulbaqi@ksu.edu.sa |
Responsible Party: | Dr. Tariq Alhawassi, Chairman of Clinical Trial Support Unit, King Saud University |
ClinicalTrials.gov Identifier: | NCT04455243 |
Other Study ID Numbers: |
E-20-4934 |
First Posted: | July 2, 2020 Key Record Dates |
Last Update Posted: | July 21, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | IPD data will be shared. However, the exact sharing plans on what or when is not yet decided. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
NAC |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |