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

NCT05736887 | Unknown Phase 2

• 1 other identifier: 499
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• DLco

  Change in percent predicted DLco at week 12 compared to baseline

  Week 12

Secondary Outcomes (7)

• DLco

  Week 12

• St. George's Respiratory Questionnaire (SGRQ)

  Week 12

• Shortness of Breath Questionnaire (UCSD-SOBQ)

  Week 12

• Change in Leicester Cough Questionnaire (LCQ)

  Week 12

• Forced Vital Capacity (FVC)

  Week 12

Study Arms (2)

N-Acetylcysteine arm

EXPERIMENTAL

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

Drug: N-Acetylcysteine

Placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

N-Acetylcysteine DRUG

N-Acetylcysteine in 600mg tablets

N-Acetylcysteine arm

Placebo DRUG

Placebo in 600mg tablets

Placebo arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 21, 2023
• Study Start: May 24, 2022
• Primary Completion: January 16, 2023
• Study Completion: June 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)