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Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19 (NACoV)

Primary Purpose

COVID-19

Status
Active
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
N-Acetylcysteine
Placebo
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 and ≤90 years. History of hospitalization for COVID-19 pneumonia, as documented by positive RT/PCR testing for SARS-Cov-2 infection (nasopharyngeal swab) and suggestive radiological findings at the chest CT scan. Resolution of SARS-CoV-2 infection as defined by negative RT/PCR testing (nasopharyngeal swab). Evidence of residual interstitial lung abnormalities (including any of the following: ground glass, reticulation, or consolidation with overall extent ≥5% of total lung volume) on chest high resolution CT scan (performed during screening or within 30 days from screening visit) AND One or more of the following: DLco ≤ 70 % of predicted value at screening Oxygen desaturation at 6-minute walk test (6MWT) ≥4% from baseline value at screening. Total Lung Capacity ≤ 80 % of predicted value at spirometry performed at screening Exertional dyspnea at screening, as defined by MMRC ≥1 Exclusion Criteria: Evidence of resting respiratory failure, as defined by PaO2 ≤60 mmHg (FiO2 21%) at blood gas analysis at screening. History of interstitial lung disease, or evidence of interstitial lung disease at screening that suggests any of the following: idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (Other than SARS-Cov-2 infection) and connective tissue diseases. History of other types of respiratory diseases, including disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study. Any other known disease, medical conditions or blood test abnormalities that in the opinion of the Investigator may put the patient at risk because of participation, interfere with study procedures or cause concern regarding the patient inability to participate in the study. Concomitant treatment with oral corticosteroids and/or other immunosuppressive drugs. Pregnancy status. Incapacity of providing valid informed consent.

Sites / Locations

  • Fondazione Policlinico Agostino Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-Acetylcysteine arm

Placebo arm

Arm Description

Subjects with recent history of COVID-19 infection randomized to receive N-Acetylcysteine.

Subjects with recent history of COVID-19 infection randomized to receive placebo.

Outcomes

Primary Outcome Measures

DLco
Change in percent predicted DLco at week 12 compared to baseline

Secondary Outcome Measures

DLco
Change in absolute (ml/min/mmHg) predicted DLco from baseline to week 12
St. George's Respiratory Questionnaire (SGRQ)
Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline to week 12.
Shortness of Breath Questionnaire (UCSD-SOBQ)
Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) score from baseline to week 12.
Change in Leicester Cough Questionnaire (LCQ)
Change in Leicester Cough Questionnaire (LCQ) from baseline to week 12.
Forced Vital Capacity (FVC)
Change in FVC (L) from baseline to week 12.
High-resolution computed tomography (HRCT)
Proportion of patients with improvement of interstitial changes on chest high-resolution computed tomography at 12 weeks, as defined by central radiological review.
Quantitative Lung Fibrosis
Change in Quantitative Lung Fibrosis (QLF) volume from baseline to week 12.

Full Information

First Posted
February 20, 2023
Last Updated
February 20, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05736887
Brief Title
Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19
Acronym
NACoV
Official Title
Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized, double-blind, parallel-arm, phase II, explorative study investigating the efficacy and safety of orally administered N-Acetylcysteine (NAC) versus placebo in patients with history of SARS-Cov-2 infection and residual respiratory impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-Acetylcysteine arm
Arm Type
Experimental
Arm Description
Subjects with recent history of COVID-19 infection randomized to receive N-Acetylcysteine.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Subjects with recent history of COVID-19 infection randomized to receive placebo.
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
N-Acetylcysteine in 600mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo in 600mg tablets
Primary Outcome Measure Information:
Title
DLco
Description
Change in percent predicted DLco at week 12 compared to baseline
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
DLco
Description
Change in absolute (ml/min/mmHg) predicted DLco from baseline to week 12
Time Frame
Week 12
Title
St. George's Respiratory Questionnaire (SGRQ)
Description
Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline to week 12.
Time Frame
Week 12
Title
Shortness of Breath Questionnaire (UCSD-SOBQ)
Description
Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) score from baseline to week 12.
Time Frame
Week 12
Title
Change in Leicester Cough Questionnaire (LCQ)
Description
Change in Leicester Cough Questionnaire (LCQ) from baseline to week 12.
Time Frame
Week 12
Title
Forced Vital Capacity (FVC)
Description
Change in FVC (L) from baseline to week 12.
Time Frame
Week 12
Title
High-resolution computed tomography (HRCT)
Description
Proportion of patients with improvement of interstitial changes on chest high-resolution computed tomography at 12 weeks, as defined by central radiological review.
Time Frame
Week 12
Title
Quantitative Lung Fibrosis
Description
Change in Quantitative Lung Fibrosis (QLF) volume from baseline to week 12.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 and ≤90 years. History of hospitalization for COVID-19 pneumonia, as documented by positive RT/PCR testing for SARS-Cov-2 infection (nasopharyngeal swab) and suggestive radiological findings at the chest CT scan. Resolution of SARS-CoV-2 infection as defined by negative RT/PCR testing (nasopharyngeal swab). Evidence of residual interstitial lung abnormalities (including any of the following: ground glass, reticulation, or consolidation with overall extent ≥5% of total lung volume) on chest high resolution CT scan (performed during screening or within 30 days from screening visit) AND One or more of the following: DLco ≤ 70 % of predicted value at screening Oxygen desaturation at 6-minute walk test (6MWT) ≥4% from baseline value at screening. Total Lung Capacity ≤ 80 % of predicted value at spirometry performed at screening Exertional dyspnea at screening, as defined by MMRC ≥1 Exclusion Criteria: Evidence of resting respiratory failure, as defined by PaO2 ≤60 mmHg (FiO2 21%) at blood gas analysis at screening. History of interstitial lung disease, or evidence of interstitial lung disease at screening that suggests any of the following: idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (Other than SARS-Cov-2 infection) and connective tissue diseases. History of other types of respiratory diseases, including disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study. Any other known disease, medical conditions or blood test abnormalities that in the opinion of the Investigator may put the patient at risk because of participation, interfere with study procedures or cause concern regarding the patient inability to participate in the study. Concomitant treatment with oral corticosteroids and/or other immunosuppressive drugs. Pregnancy status. Incapacity of providing valid informed consent.
Facility Information:
Facility Name
Fondazione Policlinico Agostino Gemelli IRCCS
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19

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