A Study of N-acetylcysteine in Patients With COVID-19 Infection

Covid-19 Clinical Trial

Official title:

Phase II Study of N-acetylcysteine in Severe or Critically Ill Patients With Refractory COVID-19 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04374461
• Other study ID #: 20-168
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator.

The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented COVID-19 infection (either performed on site or documented external report)

• Age = 18

Arm A:

• Admission to an intensive care unit at MSK (M-11) and/or receiving mechanical ventilation

• Absolute lymphocyte count = 1.0/mm3

• As the ALC of patients with lymphoid malignancies is unreliable, they may be enrolled at the discretion of the treating physician after review of their blood work.

Arm B:

• Arm B:Requiring 2L or more of supplemental oxygen by nasal cannula or higher to maintain SpO2 of 95%

Exclusion Criteria:

Arm B:

• requiring mechanical ventilation or admission to an intensive care unit at MSK (M11)

Related Conditions & MeSH terms

• Covid-19

Intervention

Drug:
• N-acetylcysteine
Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician. Treatment interruptions for up to 48 hours are permissible if there is a clinical indication to hold the study drug. Patients can restart drug if they have been off drug for less than 48 hours. Patients are also eligible to restart N-acetylcysteine treatment on the same treatment arm without reconsent if they are within the 30 day followup period after their prior course of treatment on this protocol.

Other:
• Peripheral Blood
A total of 16mL of research whole blood will be collected in CPT tubes at baseline, Cycle 2 Day 1 (or as close as feasible, when still coordinating sample collection across patients in a critical-care unit), and at end of study.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement		1 year
Primary	Arm B: number of patients who are discharged from the hospital due to clinical improvement		1 year

External Links

•   Memorial Sloan Kettering Cancer Center