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A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19 (COViNOX)

B

Bellerophon Therapeutics

Status and phase

Terminated
Phase 3

Conditions

COVID-19
Coronavirus Infection
Coronavirus

Treatments

Combination Product: INOpulse
Combination Product: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04421508
PULSE-CVD19-001

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.

Full description

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed iNO compared to placebo in subjects with COVID-19 who are hospitalized and require supplemental oxygen without assisted ventilation. Subjects will be randomized to receive placebo or iNO125 mcg/kg ideal body weight (IBW)/hour 24 hours daily up to 14 days or until resolution or discharge.

Enrollment

191 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent

  • At least 18 years old

  • Subjects must be hospitalized and have the following:

    • proven or high suspicion of SARS-CoV-2 infection and,
    • requiring oxygen supplementation defined as:
    • SpO2 ≤ 92% regardless of supplemental oxygen (ie on room air or on oxygen), or
    • SpO2 ≥ 92% on supplemental O2 and in the opinion of the Investigator it is not safe to decrease or remove the supplemental oxygen
    • require supplemental oxygen of no more than 10 L/minute, and
    • radiologic suspected or proven COVID-19 pneumonitis (chest x-ray or CT scan)
  • Female subjects must have a negative pregnancy test

  • Willing and able to comply with the treatment schedule and study procedures

Exclusion criteria

  • Participating in another clinical trial of an investigational treatment for COVID-19
  • Methemoglobin > 3%
  • Evidence of severe multi organ failure
  • Use of assisted ventilation prior to initiation of iNO
  • Pregnancy or positive pregnancy test pre-dose
  • Open tracheostomy
  • Chronic use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine, nitroprusside, isosorbide, or dapsone at screening
  • History or clinical evidence of systolic heart failure, left ventricular dysfunction (LVEF <40%)
  • Subjects reporting massive hemoptysis associated with the current illness or with radiologically proven pulmonary embolus

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

191 participants in 2 patient groups

Inhaled Nitric Oxide (iNO)
Active Comparator group
Description:
Pulsed inhaled iNO 125 mcg/kg IBW/hour
Treatment:
Combination Product: INOpulse
Placebo
Sham Comparator group
Description:
Pulsed inhaled N2, 99.999% gas
Treatment:
Combination Product: Placebo

Trial documents
2

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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