NAC for Attenuation of COVID-19 Symptomatology

NCT ID: NCT05074121

Last Updated: 2023-08-07

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

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-02-01

Brief Summary

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The objective of this study is to determine whether oral NAC is effective at attenuating COVID-19 disease symptom severity and duration of symptoms.

Detailed Description

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STUDY DESIGN: Randomized double-blinded placebo-controlled trial

ELIGIBILITY

Inclusion criteria:

* age 18 years and older
* participants will need daily access to use of a smartphone for at least six weeks from time of enrollment
* Positive COVID-19 test within 10 days of date of enrollment
* not already hospitalized for treatment of COVID

Exclusion criteria:

* pregnant
* already hospitalized for treatment of COVID

PROTOCOL

* 50:50 randomization: half of participants will take NAC, half will take placebo
* Participants will take NAC/placebo following this outpatient protocol:
* 2400 mg x 1 PO then
* 1200 mg PO BID x 14 days
* Participants will complete an online symptom-tracker for six weeks (daily for three weeks, weekly for three weeks)

Conditions

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Covid19 COVID-19 Pneumonia COVID-19 Respiratory Infection COVID-19 Lower Respiratory Infection SARS-CoV2 Infection SARS-CoV-2 Acute Respiratory Disease SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Double-Blinded Placebo-Controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Participants and study team members will be masked to whether a participant is receiving the study drug or placebo

Study Groups

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NAC

Group receiving intervention/study drug NAC

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

N-acetylcysteine

Placebo

Group receiving placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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N-acetylcysteine

N-acetylcysteine

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Other Intervention Names

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NAC N-acetyl-cysteine Acetylcysteine

Eligibility Criteria

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Inclusion Criteria

* positive COVID test \<= 7 days of enrollment

Exclusion Criteria

* pregnant
* already hospitalized due to COVID
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Thoracic Foundation

UNKNOWN

Sponsor Role collaborator

Alturix

UNKNOWN

Sponsor Role collaborator

Cambridge Health Alliance

OTHER

Sponsor Role lead

Responsible Party

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Melisa Lai-Becker

Chief, CHA Everett Emergency Department; Director, CHA Division of Medical Toxicology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cambridge Health Alliance

Everett, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Melisa Lai-Becker, MD

Role: CONTACT

617-394-7424

Tom Seufert, MD

Role: CONTACT

Facility Contacts

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Melisa Lai-Becker, MD

Role: primary

Tom Seufert, MD

Role: backup

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