NAC for Attenuation of COVID-19 Symptomatology (NACinCOVID2)

Cambridge Health Alliance

Status and phase: Not yet enrolling; Phase 2

Conditions: SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; COVID-19 Respiratory Infection; COVID-19 Pneumonia; SARS-CoV2 Infection; COVID-19 Lower Respiratory Infection; Covid19; Oxidative Stress; SARS-CoV-2 Acute Respiratory Disease

Treatments: Other: Placebo; Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifier

NCT05074121

Details and patient eligibility

About

The objective of this study is to determine whether oral NAC is effective at attenuating COVID-19 disease symptom severity and duration of symptoms.

Full 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)

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• positive COVID test <= 7 days of enrollment

Exclusion criteria

• pregnant
• already hospitalized due to COVID

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

NAC

Experimental group

Description:

Group receiving intervention/study drug NAC

Treatment:

Drug: N-acetylcysteine

Placebo

Placebo Comparator group

Description:

Group receiving placebo

Treatment:

Other: Placebo