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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
Dr. Tariq Alhawassi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring NAC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 1, 2020
    Last Updated
    July 19, 2020
    Sponsor
    Dr. Tariq Alhawassi
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    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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