Inflammatory Regulation Effect of NAC on COVID-19 Treatment | NCT04455243

Studies
Inflammatory Regulation Effect of NAC on COVID-19 Treatment

NCT04455243

Sponsor

Dr. Tariq Alhawassi

Status

Unknown status

Last Update Posted

Jul 21, 2020Actual

Enrollment

1,180Estimated

Phase

Phase 3

Conditions

COVID-19

Interventions

N-Acetyl cysteine
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Estimated

Primary Completion Date

Aug 30, 2021Estimated

Completion Date

Aug 30, 2021Estimated

First Submitted Date

Jul 1, 2020

First Submission Date that Met QC Criteria

Jul 1, 2020

First Posted Date

Jul 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2020

Last Update Posted Date

Jul 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Tariq Alhawassi, Chairman of Clinical Trial Support Unit, King Saud UniversitySponsor-Investigator

Lead Sponsor

Dr. Tariq AlhawassiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental		Drug: N-Acetyl cysteine
Control group	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-Acetyl cysteine	Drug	150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Baian Alabdulbaqi, MD	Contact	+966114670011		balabdulbaqi@ksu.edu.sa

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD data will be shared. However, the exact sharing plans on what or when is not yet decided.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided