NAC for COVID-19

(NACinCOVID2 Trial)

Overseen By Tom Seufert, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cambridge Health Alliance

Disqualifiers: Pregnant, Already hospitalized

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether oral N-acetylcysteine (NAC) can reduce the severity and duration of COVID-19 symptoms. Participants will be divided into two groups: one will receive NAC, and the other a placebo (a harmless pill with no active ingredients). The trial seeks individuals who tested positive for COVID-19 within the last week but are not hospitalized due to the virus. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the NAC for COVID-19 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

Is there any evidence suggesting that N-acetylcysteine is likely to be safe for humans?

Research has shown that N-acetylcysteine (NAC) is likely safe for humans based on past studies. NAC is already used in other medical treatments and is generally well-tolerated. Some studies found that NAC can reduce inflammation markers in the blood, such as C-reactive protein (CRP) and D-dimer, in people with COVID-19. This is promising, but it doesn't guarantee effectiveness.

While some research suggests NAC might help with COVID-19, other studies have not shown significant improvement in patient outcomes. This mixed evidence indicates that while NAC is probably safe, its effectiveness for COVID-19 remains under investigation. Always consult a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

N-acetylcysteine (NAC) is unique because it offers a different approach to treating COVID-19 compared to standard options like antivirals and monoclonal antibodies. NAC works by replenishing glutathione, a powerful antioxidant, which helps reduce inflammation and oxidative stress in the body. This mechanism is different from typical treatments that target the virus directly. Researchers are excited about NAC because its antioxidant properties could potentially lessen the severity of COVID-19 symptoms and improve outcomes, offering a complementary strategy alongside existing treatments.

What evidence suggests that NAC might be an effective treatment for COVID-19?

Research suggests that N-acetylcysteine (NAC), which participants in this trial may receive, might help with COVID-19 symptoms. Some studies have shown that NAC can reduce signs of inflammation, such as C-reactive protein and D-dimer, in COVID-19 patients, potentially making the disease less severe. However, not all studies agree; some found no improvement in patients using NAC. While there is some hope, the results remain mixed, and further research is needed for confirmation. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who have tested positive for COVID-19 within the past 7 days. It's not suitable for pregnant women or those already hospitalized due to COVID.

Inclusion Criteria

Positive COVID test <= 7 days of enrollment

Exclusion Criteria

Pregnant

Already hospitalized due to COVID

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive NAC or placebo for 14 days

2 weeks

Daily online symptom-tracker for 3 weeks

Follow-up

Participants are monitored for symptom severity and duration, and need for hospitalization

24 weeks

Weekly online symptom-tracker for 3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• N-acetylcysteine
• Placebo

Trial Overview The study aims to see if taking N-acetylcysteine (NAC) orally can reduce the severity and length of COVID-19 symptoms compared to a placebo, which has no active ingredients.

How Is the Trial Designed?

Group I: NAC Experimental Treatment 1 Intervention

Group receiving intervention/study drug NAC

Group II: Placebo Placebo Group 1 Intervention

Group receiving placebo

N-acetylcysteine is already approved in United States, European Union for the following indications:

Approved in United States as N-acetylcysteine for:

• Acetaminophen overdose
• Chronic bronchitis
• Cystic fibrosis
• Mucolytic agent

Approved in European Union as N-acetylcysteine for:

• Paracetamol overdose
• Chronic bronchitis
• Cystic fibrosis
• Mucolytic agent

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

Alturix

Collaborator

Trials

1

Recruited

200+

The Thoracic Foundation

Collaborator

Trials

1

Recruited

200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9651994/

N-acetylcysteine for prevention and treatment of COVID-19 Accordingly, preliminary data indicates that NAC improves clinical outcomes in COVID-19 patients [8], [9], and may be considered as part of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024012106

Clinical efficacy of N-acetylcysteine for COVID-19 The administration of NAC did not improve the clinical outcomes of patients with COVID-19; its routine use is not recommended for patients with SARS-CoV-2 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04419025

Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10390689/

N-acetylcysteine reduces severity and mortality in COVID-19 ... This meta-analysis suggests that NAC may have a positive effect on COVID-19 outcomes, specifically, a significant decrease in CRP and D-dimer levels.

5. itjfs.com itjfs.com/index.php/ijfs/article/view/2787

N-acetylcysteine as a promising treatment for COVID-19 NAC-treated patients exhibited significant reduction in C-reactive protein and D-dimer levels, along with higher pO2/FiO2 ratios, minimal stay ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04374461

A Study of N-acetylcysteine in Patients With COVID-19 ... The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system ...