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

NCT04401527 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: SN02-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19; Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Keywords

COVID-19; Acute Respiratory Distress Syndrome; Acute Respiratory Failure; ARDS; Respiratory Failure; Intubation; Mechanical Ventilation; Intubated; Mechanical Ventilator; ECMO; Sodium Nitrite; Nitrite; Nitric Oxide

Outcome Measures

Primary Outcomes (1)

• Survival with Unassisted Breathing

  Proportion of study subjects who are alive and free of respiratory failure at Day 28

  Day 28

Secondary Outcomes (5)

• Survival without Mechanical Ventilation

  Day 28

• Survival without Intensive Care

  Day 28

• Survival without Hospitalization

  Day 28

• Survival without ECMO

  Day 28

• Survival

  Day 28

Other Outcomes (4)

• Lung Status

  Day 14

• Kidney Status (1)

  Day 14

• Kidney Status (2)

  Day 14

Study Arms (2)

Sodium Nitrite

ACTIVE COMPARATOR

Hope Pharmaceuticals' Sodium Nitrite Injection administered by continuous intravenous infusion.

Drug: Sodium Nitrite

Placebo

PLACEBO COMPARATOR

0.9% Sodium Chloride Injection, USP (normal saline) administered by continuous intravenous infusion.

Drug: Normal Saline

Interventions

Sodium Nitrite DRUG

Continuous intravenous infusion of Sodium Nitrite Injection

Also known as: Hope Pharmaceuticals Sodium Nitrite Injection USP 30 mg/mL

Sodium Nitrite

Normal Saline DRUG

Continuous intravenous infusion of Normal Saline

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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/µL), 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.

Sponsors & Collaborators

• Hope Pharmaceuticals: lead

Study Sites (2)

Participating Research Facility

Tampa, Florida, 33606, United States

Location

Participating Research Facility

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Respiratory Insufficiency

Interventions

Sodium Nitrite; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Nitrites; Nitrous Acid; Nitrogen Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hope Pharmaceuticals Medical Director

  Hope Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 26, 2020
• Study Start: July 22, 2020
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (2)