Inflammatory Regulation Effect of NAC on COVID-19 Treatment (INFECT-19)
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
N-Acetyl cysteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring NAC
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04455243
Brief Title
Inflammatory Regulation Effect of NAC on COVID-19 Treatment
Acronym
INFECT-19
Official Title
Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Tariq Alhawassi
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
NAC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N-Acetyl cysteine
Other Intervention Name(s)
NAC
Intervention Description
150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered in the same schedule and volume as NAC
Primary Outcome Measure Information:
Title
Time to Recovery
Description
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
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baian Alabdulbaqi, MD
Phone
+966114670011
Email
balabdulbaqi@ksu.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD data will be shared. However, the exact sharing plans on what or when is not yet decided.
Learn more about this trial
Inflammatory Regulation Effect of NAC on COVID-19 Treatment
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