Inflammatory Regulation Effect of NAC on COVID-19 Treatment

NCT ID: NCT04455243

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-30

Brief Summary

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

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

Group Type EXPERIMENTAL

N-Acetyl cysteine

Intervention Type DRUG

150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)

Control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo administered in the same schedule and volume as NAC

Interventions

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N-Acetyl cysteine

150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)

Intervention Type DRUG

Placebo

Matching placebo administered in the same schedule and volume as NAC

Intervention Type DRUG

Other Intervention Names

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NAC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Tariq Alhawassi

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tariq Alhawassi

Chairman of Clinical Trial Support Unit

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Baian Alabdulbaqi, MD

Role: CONTACT

+966114670011

Other Identifiers

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E-20-4934

Identifier Type: -

Identifier Source: org_study_id

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