Covid19, COVID-19 Lower Respiratory Infection, COVID-19 Pneumonia, COVID-19 Respiratory Infection, Oxidative Stress, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, SARS-CoV-2 Acute Respiratory Disease, SARS-CoV2 Infection
Conditions
Keywords
acetylcysteine, N-acetylcysteine, N-acetyl-cysteine, NAC, glutathione
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)
Interventions
DRUGN-acetylcysteine
N-acetylcysteine
OTHERPlacebo
Placebo
Sponsors
The Thoracic Foundation
Alturix
Cambridge Health Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants and study team members will be masked to whether a participant is receiving the study drug or placebo
Intervention model description
Randomized Double-Blinded Placebo-Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* positive COVID test \<= 7 days of enrollment
Exclusion criteria
* pregnant * already hospitalized due to COVID
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Need for higher level of care/hospitalization | 24 weeks starting the day after enrollment | Comparison between groups of rates of hospitalization |
Countries
United States
Contacts
Primary ContactMelisa Lai-Becker, MD
Backup ContactTom Seufert, MD
Outcome results
None listed