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

COVID-19 Clinical Trial

— NACoV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05736887
• Other study ID #: 499
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 24, 2022
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age =18 and =90 years.

2. 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.

3. Resolution of SARS-CoV-2 infection as defined by negative RT/PCR testing (nasopharyngeal swab).

4. 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:

1. Evidence of resting respiratory failure, as defined by PaO2 =60 mmHg (FiO2 21%) at blood gas analysis at screening.

2. 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.

3. 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.

4. 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.

5. Concomitant treatment with oral corticosteroids and/or other immunosuppressive drugs.

6. Pregnancy status.

7. Incapacity of providing valid informed consent.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• N-Acetylcysteine
N-Acetylcysteine in 600mg tablets
• Placebo
Placebo in 600mg tablets

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Agostino Gemelli IRCCS	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLco	Change in percent predicted DLco at week 12 compared to baseline	Week 12
Secondary	DLco	Change in absolute (ml/min/mmHg) predicted DLco from baseline to week 12	Week 12
Secondary	St. George's Respiratory Questionnaire (SGRQ)	Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline to week 12.	Week 12
Secondary	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.	Week 12
Secondary	Change in Leicester Cough Questionnaire (LCQ)	Change in Leicester Cough Questionnaire (LCQ) from baseline to week 12.	Week 12
Secondary	Forced Vital Capacity (FVC)	Change in FVC (L) from baseline to week 12.	Week 12
Secondary	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.	Week 12
Secondary	Quantitative Lung Fibrosis	Change in Quantitative Lung Fibrosis (QLF) volume from baseline to week 12.	Week 12