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

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ClinicalTrials.gov Identifier: NCT04401527
Recruitment Status : Withdrawn (No recruitment)
First Posted : May 26, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hope Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
COVID-19 Acute Respiratory Distress Syndrome Acute Respiratory Failure Drug: Sodium Nitrite Drug: Normal Saline Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study
Actual Study Start Date : July 22, 2020
Actual Primary Completion Date : August 15, 2020
Actual Study Completion Date : August 15, 2020


Arm Intervention/treatment
Active Comparator: Sodium Nitrite
Hope Pharmaceuticals' Sodium Nitrite Injection administered by continuous intravenous infusion.
Drug: Sodium Nitrite
Continuous intravenous infusion of Sodium Nitrite Injection
Other Name: Hope Pharmaceuticals Sodium Nitrite Injection USP 30 mg/mL

Placebo Comparator: Placebo
0.9% Sodium Chloride Injection, USP (normal saline) administered by continuous intravenous infusion.
Drug: Normal Saline
Continuous intravenous infusion of Normal Saline
Other Name: Placebo




Primary Outcome Measures :
  1. Survival with Unassisted Breathing [ Time Frame: Day 28 ]
    Proportion of study subjects who are alive and free of respiratory failure at Day 28


Secondary Outcome Measures :
  1. Survival without Mechanical Ventilation [ Time Frame: Day 28 ]
    Number of days alive without mechanical ventilation from start of study through Day 28

  2. Survival without Intensive Care [ Time Frame: Day 28 ]
    Number of days alive and not in the intensive care unit from start of study through Day 28.

  3. Survival without Hospitalization [ Time Frame: Day 28 ]
    Number of days alive and not in hospital from start of study through Day 28.

  4. Survival without ECMO [ Time Frame: Day 28 ]
    Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.

  5. Survival [ Time Frame: Day 28 ]
    Alive on Day 28


Other Outcome Measures:
  1. Lung Status [ Time Frame: Day 14 ]
    Oxygenation index (PaO2/FIO2) at Day 14

  2. Kidney Status (1) [ Time Frame: Day 14 ]
    Blood urea nitrogen (BUN) at Day 14

  3. Kidney Status (2) [ Time Frame: Day 14 ]
    Creatinine at Day 14

  4. Liver Status [ Time Frame: Day 14 ]
    Liver function tests (ALT and AST) at Day 14



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401527


Locations
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United States, Florida
Participating Research Facility
Tampa, Florida, United States, 33606
United States, Texas
Participating Research Facility
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Hope Pharmaceuticals
Investigators
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Study Director: Hope Pharmaceuticals Medical Director Hope Pharmaceuticals
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Responsible Party: Hope Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04401527    
Other Study ID Numbers: SN02-01
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hope Pharmaceuticals:
COVID-19
Acute Respiratory Distress Syndrome
Acute Respiratory Failure
ARDS
Respiratory Failure
Intubation
Mechanical Ventilation
Intubated
Mechanical Ventilator
ECMO
Sodium Nitrite
Nitrite
Nitric Oxide
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries