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NACinCOVID2: NAC for Attenuation of COVID-19 Symptomatology

Sponsor
Cambridge Health Alliance (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05074121
Collaborator
The Thoracic Foundation (Other), Alturix (Other)
200
Enrollment
1
Location
2
Arms
10.1
Anticipated Duration (Months)
19.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Double-Blinded Placebo-ControlledRandomized Double-Blinded Placebo-Controlled
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Participants and study team members will be masked to whether a participant is receiving the study drug or placebo
Primary Purpose:
Treatment
Official Title:
N-acetylcysteine for Attenuation of COVID Symptomatology
Anticipated Study Start Date :
Mar 31, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: NAC

Group receiving intervention/study drug NAC

Drug: N-acetylcysteine
N-acetylcysteine
Other Names:
  • NAC
  • N-acetyl-cysteine
  • Acetylcysteine

    		•
    Placebo Comparator: Placebo

    Group receiving placebo

    Other: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Symptom severity [24 weeks starting the day after enrollment]

      Severity of symptoms

    2. Symptom duration [24 weeks starting the day after enrollment]

      Length in days of symptoms

    Secondary Outcome Measures

    1. Need for higher level of care/hospitalization [24 weeks starting the day after enrollment]

      Comparison between groups of rates of hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • positive COVID test <= 7 days of enrollment
    Exclusion Criteria:

    • pregnant

    • already hospitalized due to COVID

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cambridge Health Alliance Everett Massachusetts United States 02149

    Sponsors and Collaborators

    • Cambridge Health Alliance
    • The Thoracic Foundation
    • Alturix

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melisa Lai-Becker, Chief, CHA Everett Emergency Department; Director, CHA Division of Medical Toxicology, Cambridge Health Alliance
    ClinicalTrials.gov Identifier:
    NCT05074121
    Other Study ID Numbers:
      First Posted:
      Oct 12, 2021
      Last Update Posted:
      Jan 21, 2022
      Last Verified:
      Jan 1, 2022
      Individual Participant Data (IPD) Sharing Statement:
      Yes
      Plan to Share IPD:
      Yes
      Studies a U.S. FDA-regulated Drug Product:
      Yes
      Studies a U.S. FDA-regulated Device Product:
      No
      Product Manufactured in and Exported from the U.S.:
      No
      Keywords provided by Melisa Lai-Becker, Chief, CHA Everett Emergency Department; Director, CHA Division of Medical Toxicology, Cambridge Health Alliance
      acetylcysteine
      N-acetylcysteine
      N-acetyl-cysteine
      NAC
      glutathione
      Additional relevant MeSH terms:
      Infections
      Communicable Diseases
      COVID-19
      Respiratory Tract Infections
      Severe Acute Respiratory Syndrome
      Respiration Disorders
      Respiratory Tract Diseases
      Acetylcysteine
      N-monoacetylcystine

      Study Results

      No Results Posted as of Jan 21, 2022