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

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Hope Pharmaceuticals
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Updated on 16 February 2024
See if I qualify
mechanical ventilation
intubation
covid-19
lung injury
SARS
respiratory failure
sodium nitrite injection
absolute lymphocyte count
ventilator-induced lung injury
ventilator induced lung injury
normal saline
acute respiratory syndrome (sars)
ventilator-associated lung injury

Summary

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.

Description

This Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation. The primary objective is to compare the two treatment groups with respect to the proportion of study subjects who are alive and free of respiratory failure at Day 28.

Details
Condition Pulmonary Disease, ADULT RESPIRATORY DISTRESS SYNDROME, Acute Respiratory Failure, Covid 19
Age 18years - 100years
Treatment Normal saline, Sodium Nitrite
Clinical Study IdentifierNCT04401527
SponsorHope Pharmaceuticals
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

18 years of age or older
Diagnosed COVID-19 disease with confirmed SARS-coV-2 viral infection
Able to sign the informed consent form (ICF) or next of kin/legal guardian able to sign informed consent
Randomization within 24 hours of intubation and mechanical ventilation due to respiratory failure from COVID-19 infection
Absolute lymphocyte count > 800 / mm3
Women of childbearing potential (WCBP) must have a negative urine or serum (if anuric) pregnancy test at screening
WCBP must agree to abstain from sex or use an adequate method of contraception from the time of informed consent through Day 28
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

Methemoglobinemia > 2%
Hypotension with systemic blood pressure < 90/60 mm Hg, or uncontrolled hypotension despite vasopressor support
History of sickle cell disease, thalassemia, G6PD deficiency, lung transplant, or allergy to sodium nitrite
Hemoglobin < 8 gm/dL
Renal impairment with creatinine clearance < 60 mL/min/1.73m2
Treatment within the past 48 hours with allopurinol (a medication that could interfere with nitrite metabolism)
Treatment within the past 24 hours with organic nitrates such as nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, sodium nitroprusside, and inhaled nitric oxide
Treatment within the past 24 hours with lidocaine, prilocaine, benzocaine, and dapsone
Requiring extracorporeal membrane oxygenation (ECMO)
Subjects with bacterial or fungal infections except for mild cutaneous infections or sinus infections
Subjects who are pregnant or lactating
Any condition that, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study
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/L), and/or active hepatitis B or C, cirrhosis, or uncontrolled psychiatric illness/social situations that would limit compliance with study requirements
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
Moribund or not expected to survive 48 hours
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mechanical ventilation
intubation
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lung injury
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respiratory failure
sodium nitrite injection
absolute lymphocyte count
ventilator-induced lung injury
ventilator induced lung injury
normal saline
acute respiratory syndrome (sars)
ventilator-associated lung injury

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