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

COVID-19 Clinical Trial

Official title:

Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04401527
• Other study ID #: SN02-01
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 22, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: September 2020
• Source: Hope Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• COVID-19
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Drug:
• Sodium Nitrite
Continuous intravenous infusion of Sodium Nitrite Injection
• Normal Saline
Continuous intravenous infusion of Normal Saline

Locations

Country	Name	City	State
United States	Participating Research Facility	Fort Worth	Texas
United States	Participating Research Facility	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hope Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung Status	Oxygenation index (PaO2/FIO2) at Day 14	Day 14
Other	Kidney Status (1)	Blood urea nitrogen (BUN) at Day 14	Day 14
Other	Kidney Status (2)	Creatinine at Day 14	Day 14
Other	Liver Status	Liver function tests (ALT and AST) at Day 14	Day 14
Primary	Survival with Unassisted Breathing	Proportion of study subjects who are alive and free of respiratory failure at Day 28	Day 28
Secondary	Survival without Mechanical Ventilation	Number of days alive without mechanical ventilation from start of study through Day 28	Day 28
Secondary	Survival without Intensive Care	Number of days alive and not in the intensive care unit from start of study through Day 28.	Day 28
Secondary	Survival without Hospitalization	Number of days alive and not in hospital from start of study through Day 28.	Day 28
Secondary	Survival without ECMO	Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.	Day 28
Secondary	Survival	Alive on Day 28	Day 28