Inflammatory Regulation Effect of NAC on COVID-19 Treatment
INFECT-19
Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19
1 other identifier
interventional
1,180
0 countries
N/A
Brief Summary
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Aug 2020
Typical duration for phase_3 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedJuly 21, 2020
July 1, 2020
1.1 years
July 1, 2020
July 19, 2020
Conditions
Keywords
Outcome Measures
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
28 days
Study Arms (2)
Intervention group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)
Eligibility Criteria
You may qualify if:
- Adult above 18 years of age
- Admitted to the hospital With confirmed COVID-19 by RT-PCR test
- On oxygen supplement
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chairman of Clinical Trial Support Unit
Study Record Dates
First Submitted
July 1, 2020
First Posted
July 2, 2020
Study Start
August 1, 2020
Primary Completion
August 30, 2021
Study Completion
August 30, 2021
Last Updated
July 21, 2020
Record last verified: 2020-07