COVID-19Phase 2NCT04401527
Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite
A Phase 2 study testing Sodium Nitrite and Normal Saline in people with COVID-19 and Acute Respiratory Distress Syndrome, run by Hope Pharmaceuticals at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- What is being tested?
- Sodium Nitrite and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2020to 15 Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Participating Research Facility
Fort Worth, Texas, 76104
Participating Research Facility
Tampa, Florida, 33606
About this study
Official title: Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study
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.
Read the 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.
- Being tested
- Sodium Nitrite, Normal Saline
- 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
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NitriteDrug
Also called Hope Pharmaceuticals Sodium Nitrite Injection USP 30 mg/mL
Continuous intravenous infusion of Sodium Nitrite Injection
Normal SalineDrug
Also called Placebo
Continuous intravenous infusion of Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Sodium Nitrite | Active comparator | Hope Pharmaceuticals' Sodium Nitrite Injection administered by continuous intravenous infusion. Receives: Drug: Sodium Nitrite |
| Placebo | Placebo comparator | 0.9% Sodium Chloride Injection, USP (normal saline) administered by continuous intravenous infusion. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with Unassisted Breathing
Proportion of study subjects who are alive and free of respiratory failure at Day 28
Measured: Day 28
Secondary outcomes (5)
Survival without Mechanical Ventilation
Number of days alive without mechanical ventilation from start of study through Day 28
Measured: Day 28
Survival without Intensive Care
Number of days alive and not in the intensive care unit from start of study through Day 28.
Measured: Day 28
Survival without Hospitalization
Number of days alive and not in hospital from start of study through Day 28.
Measured: Day 28
Survival without ECMO
Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.
Measured: Day 28
Survival
Alive on Day 28
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start22 Jul 2020
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hope Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hope Pharmaceuticals Medical Director, Study director, Hope Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401527
- Sponsor's protocol ID
- SN02-01
- Status last verified
- Sep 2020
- First submitted
- 21 May 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study
- ClinicalTrials.gov ID
- NCT04401527
- Acronym / sponsor ID
- SN02-01
- Keywords
- COVID-19, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, ARDS, Respiratory Failure, Intubation, Mechanical Ventilation, Intubated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hope PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Nitrite | Active comparator | Drug: Sodium NitriteHope Pharmaceuticals' Sodium Nitrite Injection administered by continuous intravenous infusion. |
| Placebo | Placebo comparator | Drug: Normal Saline0.9% Sodium Chloride Injection, USP (normal saline) administered by continuous intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium NitriteAlso: Hope Pharmaceuticals Sodium Nitrite Injection USP 30 mg/mLContinuous intravenous infusion of Sodium Nitrite Injection | Drug | Sodium Nitrite |
| Normal SalineAlso: PlaceboContinuous intravenous infusion of Normal Saline | Drug | Placebo |
Primary outcome
Survival with Unassisted Breathing
Time frame: Day 28
Proportion of study subjects who are alive and free of respiratory failure at Day 28
5 secondary outcomes
Survival without Mechanical Ventilation
Time frame: Day 28
Survival without Intensive Care
Time frame: Day 28
Survival without Hospitalization
Time frame: Day 28
Survival without ECMO
Time frame: Day 28
Survival
Time frame: Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hope Pharmaceuticals Medical Director study director
Hope Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Nitrite and Normal Saline in people with COVID-19 and Acute Respiratory Distress Syndrome, run by Hope Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival with Unassisted Breathing (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.