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

NCT04421508 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2023-02-21

Study results available
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Summary

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.

Conditions

  • COVID-19
  • Coronavirus
  • Coronavirus Infection

Interventions

COMBINATION_PRODUCT

INOpulse

Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

COMBINATION_PRODUCT

Placebo

Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

Sponsors & Collaborators

  • Bellerophon Pulse Technologies

    lead INDUSTRY

Principal Investigators

  • Ashika Ahmed, MD · Bellerophon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-12
Primary Completion
2020-12-28
Completion
2021-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04421508 on ClinicalTrials.gov