iNOPulse for COVID-19

NCT04398290 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 20200449
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.

Conditions

COVID-19; Hypoxemia; Hypoxemic Respiratory Failure

Keywords

hypoxemia; respiratory failure; COVID-19; inhaled nitric oxide

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment emergent adverse events

  As assessed per treating physician's discretion.

  Up to 14 days

• Incidence of adverse events

  Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.

  Up to 6 hours

• Incidence of methemoglobinemia

  Incidence of increase to \> 5% total methemoglobin as assessed by pulse oximetry.

  Up to 14 days

Secondary Outcomes (4)

• Number of participants with progression of respiratory failure

  Up to 14 days

• Time until resolution of hypoxemia

  Up to 14 days

• Incidence of mortality

  Up to 28 days

• Duration of hospitalization

  Up to 28 days

Study Arms (2)

iNOpulse Treatment Group

EXPERIMENTAL

Participants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days.

Drug: Inhaled nitric oxide (iNO); Drug: Oxygen gas

Placebo Group

ACTIVE COMPARATOR

Participants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days

Drug: Nitrogen gas; Drug: Oxygen gas

Interventions

Inhaled nitric oxide (iNO) DRUG

iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour

iNOpulse Treatment Group

Nitrogen gas DRUG

250 mcg/kg ideal body weight (IBW)/hour

Placebo Group

Oxygen gas DRUG

Supplemental oxygen administered via nasal cannula

Placebo Group; iNOpulse Treatment Group

Eligibility Criteria

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

You may qualify if:

• Age 18 or above
• Proven COVID-19 viral infection. Non-confirmed highly suspicious suspects may be enrolled.
• Presence of radiographic findings compatible with pneumonia/pneumonitis.
• Patients requiring at least 3 L/m oxygen via nasal canula to maintain O2 above 92%.
• Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine).
• Willing and able to comply with treatment schedule and study procedures.

You may not qualify if:

• Patient with severe hypoxemia who are unable to maintain an oxygen saturation (SpO2) \> 88% on a maximum supplemental oxygen of 6 L/m by nasal cannula and a non-rebreather facemask.
• Participating in any other clinical trial for COVID-19
• Pregnancy, or positive pregnancy test in a pre-dose examination.
• Open tracheostomy.
• Clinical contra-indication, as deemed by the PI or their designee.
• Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as intravenous lidocaine, or topical benzocaine or dapsone at screening.
• Known history or clinical evidence of heart failure or left ventricular dysfunction (LVEF \< 45%).
• Significant hemoptysis
• Unable to provide informed consent (proxy consent is acceptable if available)
• Any of the following conditions at time of possible enrollment: Fulminant Liver Failure, Acute Coronary Syndrome , Renal Failure requiring dialysis, Bacteremia, Shock, Cardiac arrest, Cardiac arrhythmia requiring acute treatment, Delirium / Encephalopathy, Severe Disseminated Intravascular Coagulation, Gastrointestinal hemorrhage, Hypoglycemia, Pneumothorax, Rhabdomyolysis / Myositis, Seizures, or Acute Stroke

Sponsors & Collaborators

• Roger Alvarez: lead
• Bellerophon Therapeutics: collaborator

Study Sites (1)

University of Miami Hospitals & Clinics

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

COVID-19; Hypoxia; Respiratory Insufficiency

Interventions

Nitrogen; nitrox

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; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Study Officials

• Roger A Alvarez, D.O.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine Pulmonary Vascular Diseases

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 21, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 15, 2021
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)