NAC for Attenuation of COVID-19 Symptomatology

Phase 2

Not yet recruiting

• Conditions: Covid19; COVID-19 Lower Respiratory Infection; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Oxidative Stress; COVID-19 Pneumonia; SARS-CoV-2 Acute Respiratory Disease; COVID-19 Respiratory Infection; SARS-CoV2 Infection
• Interventions: Other: Placebo; Drug: N-acetylcysteine

• Registration Number: NCT05074121
• Lead Sponsor: Cambridge Health Alliance

Brief 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.

Detailed 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)

Study Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07
• Study Start: 2024-03-31
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• positive COVID test <= 7 days of enrollment

Exclusion Criteria

• pregnant
• already hospitalized due to COVID

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Group receiving placebo
NAC	N-acetylcysteine	Group receiving intervention/study drug NAC

Primary Outcome Measures

Name	Time	Method
Symptom severity	24 weeks starting the day after enrollment	Severity of symptoms
Symptom duration	24 weeks starting the day after enrollment	Length in days of symptoms

Secondary Outcome Measures

Name	Time	Method
Need for higher level of care/hospitalization	24 weeks starting the day after enrollment	Comparison between groups of rates of hospitalization

Trial Locations

Locations (1)

Cambridge Health Alliance; 🇺🇸 Everett, Massachusetts, United States