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NCT05074121 Clinical Trial

NAC for Attenuation of COVID-19 Symptomatology

Covid19 Clinical Trial

— NACinCOVID2  

Official title:
N-acetylcysteine for Attenuation of COVID Symptomatology

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05074121
Other study ID #
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 31, 2024
Est. completion date February 1, 2025

Study information
Verified date August 2023
Source Cambridge Health Alliance
Contact Melisa Lai-Becker, MD
Phone 617-394-7424
Email melaibecker@cha.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date February 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - positive COVID test <= 7 days of enrollment Exclusion Criteria: - pregnant - already hospitalized due to COVID

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• N-acetylcysteine
N-acetylcysteine
Other:
• Placebo
Placebo

Locations
Country Name City State
United States Cambridge Health Alliance Everett Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Cambridge Health Alliance Alturix, The Thoracic Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom severity Severity of symptoms 24 weeks starting the day after enrollment
Primary Symptom duration Length in days of symptoms 24 weeks starting the day after enrollment
Secondary Need for higher level of care/hospitalization Comparison between groups of rates of hospitalization 24 weeks starting the day after enrollment
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