What side effects are associated with this type of intervention?

Common treatments for COVID-19 that involve antioxidants and glutathione replenishment, such as N-acetylcysteine (NAC), have been associated with several side effects. NAC can cause nausea, vomiting, and allergic reactions. Other antioxidant therapies, like vitamin C, have shown potential benefits but also present conflicting data regarding their impact on mortality and symptom duration. Overall, while these treatments may offer some benefits, their side effects and efficacy are still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, focusing on different mechanisms of action. Remdesivir, an antiviral drug, was one of the first to receive approval. Monoclonal antibodies, such as bamlanivimab and casirivimab/imdevimab, were also authorized for emergency use, although their efficacy varies with different SARS-CoV-2 variants. While N-acetylcysteine (NAC) is being studied for its potential benefits in COVID-19 due to its antioxidant properties and ability to replenish glutathione, it has not yet received FDA approval specifically for COVID-19 treatment. Other antioxidant therapies and micronutrient supplements are still under investigation, and their clinical efficacy remains to be conclusively determined.

What other types of research exist?

Promising alternatives to N-acetylcysteine (NAC) for COVID-19 patients include agents with strong antioxidant properties and those that can replenish glutathione. Potential candidates include glutathione itself, vitamin C (ascorbic acid), and selenium. These agents have been studied for their ability to reduce oxidative stress and support immune function. Additionally, emerging treatments such as melatonin, which has antioxidant and anti-inflammatory properties, and quercetin, a flavonoid with antiviral and antioxidant effects, are being explored for their potential benefits in COVID-19 management.

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Mucolytic Agent

NAC for COVID-19 (NACinCOVID2 Trial)

Phase 2

Waitlist Available

Research Sponsored by Cambridge Health Alliance

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks starting the day after enrollment

Summary

This trial is testing if taking an NAC supplement can make COVID-19 symptoms less severe and shorter in adults who have tested positive but are not hospitalized.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of NAC may include nausea, vomiting, rash, and headache. The placebo is unlikely to cause any direct side effects since it doesn't contain an active drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks starting the day after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks starting the day after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks starting the day after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Symptom duration

Symptom severity

Secondary study objectives

Need for higher level of care/hospitalization

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NACExperimental Treatment1 Intervention

Group receiving intervention/study drug NAC

Group II: PlaceboPlacebo Group1 Intervention

Group receiving placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

N-acetylcysteine

2008

Completed Phase 4

~1290

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

N-acetylcysteine (NAC) works primarily as an antioxidant and a precursor to glutathione, a critical molecule in the body's defense against oxidative stress. By replenishing glutathione levels, NAC helps reduce oxidative damage and inflammation, which are significant contributors to the severity of COVID-19. This mechanism is crucial for COVID-19 patients because the virus can induce a hyperinflammatory state and oxidative stress, leading to severe respiratory and systemic complications. Other treatments with similar antioxidant and anti-inflammatory properties aim to mitigate these effects, thereby potentially reducing the severity and duration of symptoms.

Participation of nitrogen oxide and its metabolites in the genesis of hyperimmune inflammation in COVID-19.Use of N-Acetylcysteine at high doses as an oral treatment for patients hospitalized with COVID-19.Reaction Cycles of Halogen Species in the Immune Defense: Implications for Human Health and Diseases and the Pathology and Treatment of COVID-19.