Covid19Phase 2NACinCOVID2NCT05074121
NAC for Attenuation of COVID-19 Symptomatology
A Phase 2 study testing N-acetylcysteine in people with Covid19 and COVID-19 Pneumonia, run by Cambridge Health Alliance at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2024to 1 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- positive COVID test <= 7 days of enrollment
Who cannot join
- pregnant
- already hospitalized due to COVID
Trial locations and contacts
1 site in 1 country.
Tom Seufert, MD contact
United States1 site
Cambridge Health Alliance
Everett, Massachusetts, 02149
Melisa Lai-Becker, MD, melaibecker@cha.harvard.edu
Tom Seufert, MD, tseufert@cha.harvard.edu
About this study
Official title: N-acetylcysteine for Attenuation of COVID Symptomatology
The objective of this study is to determine whether oral NAC is effective at attenuating COVID-19 disease symptom severity and duration of symptoms.
Read the 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)
- Conditions
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Lower Respiratory Infection, SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease
- Being tested
- N-acetylcysteine, Placebo
- Keywords
- acetylcysteine, N-acetylcysteine, N-acetyl-cysteine, NAC, glutathione
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Also called NAC, N-acetyl-cysteine, Acetylcysteine
N-acetylcysteine
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NAC | Experimental | Group receiving intervention/study drug NAC Receives: Drug: N-acetylcysteine |
| Placebo | Placebo comparator | Group receiving placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity
Severity of symptoms
Measured: 24 weeks starting the day after enrollment
Symptom duration
Length in days of symptoms
Measured: 24 weeks starting the day after enrollment
Secondary outcomes (1)
Need for higher level of care/hospitalization
Comparison between groups of rates of hospitalization
Measured: 24 weeks starting the day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start31 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double-Blinded Placebo-Controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- The Thoracic Foundation, Alturix
- Responsible party
- Principal investigator, Melisa Lai-Becker, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074121
- Acronym
- NACinCOVID2
- Status last verified
- Aug 2023
- First submitted
- 5 Oct 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data used for publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine for Attenuation of COVID Symptomatology
- ClinicalTrials.gov ID
- NCT05074121
- Acronym / sponsor ID
- NACinCOVID2
- Conditions
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Lower Respiratory Infection, SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease
- Keywords
- acetylcysteine, N-acetylcysteine, N-acetyl-cysteine, NAC, glutathione
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- The Thoracic Foundation, Alturix
- Study start
- 31 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Double-Blinded Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| NAC | Experimental | Drug: N-acetylcysteineGroup receiving intervention/study drug NAC |
| Placebo | Placebo comparator | Other: PlaceboGroup receiving placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- positive COVID test <= 7 days of enrollment
Key exclusion criteria (2 listed)
- pregnant
- already hospitalized due to COVID
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineAlso: NAC, N-acetyl-cysteine, AcetylcysteineN-acetylcysteine | Drug | NAC |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Symptom severity
Time frame: 24 weeks starting the day after enrollment
Severity of symptoms
Symptom duration
Time frame: 24 weeks starting the day after enrollment
Length in days of symptoms
1 secondary outcome
Need for higher level of care/hospitalization
Time frame: 24 weeks starting the day after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Yes. Study data used for publication
Related trials for Covid19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Seufert, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with Covid19 and COVID-19 Pneumonia, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melisa Lai-Becker, MD (617-394-7424, melaibecker@cha.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity (time frame: 24 weeks starting the day after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.