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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. Read our disclaimer for details. Identifier: NCT04455243
Recruitment Status : Unknown
Verified July 2020 by Dr. Tariq Alhawassi, King Saud University.
Recruitment status was:  Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 21, 2020
Information provided by (Responsible Party):
Dr. Tariq Alhawassi, King Saud University

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

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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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04455243

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Contact: Baian Alabdulbaqi, MD +966114670011

Sponsors and Collaborators
Dr. Tariq Alhawassi
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Responsible Party: Dr. Tariq Alhawassi, Chairman of Clinical Trial Support Unit, King Saud University 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:
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs