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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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||
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
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, MDfirstname.lastname@example.org|