The study researchers think that a medication called N-acetylcysteine can help fight theCOVID-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 infectionwill get better, which could allow the patient to be moved out of the critical care unitor go off a ventilator, or prevent them from moving into a critical care unit or going ona ventilator.The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat theliver side effects resulting from an overdose of the anti-inflammatory medicationTylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in thelungs 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-19infections.
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.
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)
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Santosha Vardhana, MD, PhD, Principal Investigator
Memorial Sloan Kettering Cancer Center