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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Covid-19

Treatments: Drug: N-acetylcysteine; Other: Peripheral Blood

Study type: Interventional

Funder types: Other

Identifiers

NCT04374461

20-168

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

mechanically ventilated &/or managed in a critical-care

Experimental group

Description:

This arm is closed to accrual as of September 2020. 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. Patients will receive treatment for a maximum of 3 weeks or until one of the following: Arm A: * Transfer out of the critical-care unit * Extubation * Toxicity * Death

Treatment:

Other: Peripheral Blood

Drug: N-acetylcysteine

non-mechanically ventilated, non-critical-care

Experimental group

Description:

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. Patients will receive treatment for a maximum of 3 weeks or until one of the following: Arm B: * Discharge from hospital * Admission to a critical-care unit * Intubation * Toxicity * Death

Treatment:

Other: Peripheral Blood

Drug: N-acetylcysteine