Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite

Inclusion Criteria:

1. 18 years of age or older;

2. Diagnosed COVID-19 disease with confirmed SARS-coV-2 viral infection;

3. Able to sign the informed consent form (ICF) or next of kin/legal guardian able to
sign informed consent;

4. Randomization within 24 hours of intubation and mechanical ventilation due to
respiratory failure from COVID-19 infection;

5. Absolute lymphocyte count > 800 / mm3;

6. Women of childbearing potential (WCBP) must have a negative urine or serum (if anuric)
pregnancy test at screening;

7. WCBP must agree to abstain from sex or use an adequate method of contraception from
the time of informed consent through Day 28;

8. Males must abstain from sex with WCBP or use an adequate method of contraception from
the time of informed consent through Day 28.

Exclusion Criteria:

1. Methemoglobinemia > 2%;

2. Hypotension with systemic blood pressure < 90/60 mm Hg, or uncontrolled hypotension
despite vasopressor support;

3. History of sickle cell disease, thalassemia, G6PD deficiency, lung transplant, or
allergy to sodium nitrite;

4. Hemoglobin < 8 gm/dL;

5. Renal impairment with creatinine clearance < 60 mL/min/1.73m2;

6. Treatment within the past 48 hours with allopurinol (a medication that could interfere
with nitrite metabolism);

7. Treatment within the past 24 hours with organic nitrates such as nitroglycerin,
isosorbide mononitrate, isosorbide dinitrate, sodium nitroprusside, and inhaled nitric
oxide;

8. Treatment within the past 24 hours with lidocaine, prilocaine, benzocaine, and
dapsone;

9. Requiring extracorporeal membrane oxygenation (ECMO);

10. Subjects with bacterial or fungal infections except for mild cutaneous infections or
sinus infections;

11. Subjects who are pregnant or lactating;

12. Any condition that, in the opinion of the Investigator, places the subject at
unacceptable risk if he/she were to participate in the study;

13. Clinically relevant serious co-morbid medical conditions including, but not limited
to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension,
uncontrolled cardiac arrhythmias, uncontrolled chronic obstructive or chronic
restrictive pulmonary disease, active central nervous system (CNS) disease
uncontrolled by standard of care, known positive status for human immunodeficiency
virus (HIV) (except if HIV subject has undetectable viral load and a CD4 count of ≥
500 cells/µL), and/or active hepatitis B or C, cirrhosis, or uncontrolled psychiatric
illness/social situations that would limit compliance with study requirements;

14. Treatment within 30 days or 5 half-lives of that agent (whichever is shorter) before
the first study drug dose using another investigational drug. Notwithstanding,
prospective subjects who receive any of the following drugs or treatments before the
first study drug dose or during this study may be considered for participation in this
study: (1) a commercially available, FDA-approved drug or treatment used off-label for
the treatment of COVID-19, or (2) a drug or treatment that has FDA Emergency Use
Authorization for the treatment of COVID-19 patients;

15. Moribund or not expected to survive 48 hours.