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Inflammatory Regulation Effect of NAC on COVID-19 Treatment (INFECT-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04455243
Recruitment Status : Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Tariq Alhawassi, King Saud University

Tracking Information
First Submitted Date  ICMJE July 1, 2020
First Posted Date  ICMJE July 2, 2020
Last Update Posted Date July 21, 2020
Estimated Study Start Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
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
  1. Not-Hospitalized, No limitation on activity.
  2. Not Hospitalized, with limitation on activity.
  3. Hospitalized, Not requiring supplemental Oxygen
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inflammatory Regulation Effect of NAC on COVID-19 Treatment
Official Title  ICMJE Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19
Brief Summary Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Matching placebo administered in the same schedule and volume as NAC
Study Arms  ICMJE
  • Experimental: Intervention group
    Intervention: Drug: N-Acetyl cysteine
  • Placebo Comparator: Control group
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2020)
1180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Baian Alabdulbaqi, MD +966114670011 balabdulbaqi@ksu.edu.sa
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04455243
Other Study ID Numbers  ICMJE E-20-4934
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Dr. Tariq Alhawassi, King Saud University
Study Sponsor  ICMJE Dr. Tariq Alhawassi
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account King Saud University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP