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iNOPulse for COVID-19 (NO-COVER)

Primary Purpose

COVID-19, Hypoxemia, Hypoxemic Respiratory Failure

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Inhaled nitric oxide (iNO)

Nitrogen gas

Oxygen gas

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring hypoxemia, respiratory failure, COVID-19, inhaled nitric oxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

University of Miami Hospitals & Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iNOpulse Treatment Group

Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events

As assessed per treating physician's discretion.

Incidence of adverse events

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

Incidence of methemoglobinemia

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

Secondary Outcome Measures

Number of participants with progression of respiratory failure

Worsening respiratory status as defined by any one of the following: Implementation of High Flow Nasal Cannula (HFNC), non-rebreather mask, non-invasive ventilation, intubation and mechanical ventilation or need for intubation (in the event the patient is not intubated due to do not intubate (DNI) or do not resuscitate (DNR) status).

Time until resolution of hypoxemia

The number of days until hypoxemia is resolved as per treating physician assessment

Incidence of mortality

Incidence of death during hospitalization and after discharge up to 28 days

Duration of hospitalization

Number of days of hospitalization

Full Information

NCT ID

NCT04398290

First Posted

May 20, 2020

Last Updated

August 17, 2020

Sponsor

Roger Alvarez

Collaborators

Bellerophon Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04398290

Brief Title

iNOPulse for COVID-19

Acronym

NO-COVER

Official Title

Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Withdrawn

Why Stopped

IRB AND FDA REVIEWS DEFERRED

Study Start Date

December 1, 2020 (Anticipated)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

July 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Roger Alvarez

Collaborators

Bellerophon Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Hypoxemia, Hypoxemic Respiratory Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iNOpulse Treatment Group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Inhaled nitric oxide (iNO)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nitrogen gas

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxygen gas

Intervention Description

Supplemental oxygen administered via nasal cannula

Primary Outcome Measure Information:

Title

Incidence of treatment emergent adverse events

Description

As assessed per treating physician's discretion.

Time Frame

Up to 14 days

Title

Incidence of adverse events

Description

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

Time Frame

Up to 6 hours

Title

Incidence of methemoglobinemia

Description

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

Time Frame

Up to 14 days

Secondary Outcome Measure Information:

Title

Number of participants with progression of respiratory failure

Description

Time Frame

Up to 14 days

Title

Time until resolution of hypoxemia

Description

The number of days until hypoxemia is resolved as per treating physician assessment

Time Frame

Up to 14 days

Title

Incidence of mortality

Description

Incidence of death during hospitalization and after discharge up to 28 days

Time Frame

Up to 28 days

Title

Duration of hospitalization

Description

Number of days of hospitalization

Time Frame

Up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger A Alvarez, D.O.

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami Hospitals & Clinics

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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iNOPulse for COVID-19

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