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

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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

Study Description
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Brief Summary:
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: N-Acetyl cysteine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Drug: Placebo
Matching placebo administered in the same schedule and volume as NAC


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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


Contacts
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Contact: Baian Alabdulbaqi, MD +966114670011 balabdulbaqi@ksu.edu.sa

Sponsors and Collaborators
Dr. Tariq Alhawassi
More Information
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Responsible Party: Dr. Tariq Alhawassi, Chairman of Clinical Trial Support Unit, King Saud University
ClinicalTrials.gov Identifier: NCT04455243    
Other Study ID Numbers: E-20-4934
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Keywords provided by Dr. Tariq Alhawassi, King Saud University:
NAC
Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
 Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes