iNOPulse for COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-07-15

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 Hypoxemia Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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iNOpulse Treatment Group

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

Group Type EXPERIMENTAL

Inhaled nitric oxide (iNO)

Intervention Type DRUG

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

Oxygen gas

Intervention Type DRUG

Supplemental oxygen administered via nasal cannula

Placebo Group

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

Group Type ACTIVE_COMPARATOR

Nitrogen gas

Intervention Type DRUG

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

Oxygen gas

Intervention Type DRUG

Supplemental oxygen administered via nasal cannula

Interventions

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Inhaled nitric oxide (iNO)

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

Intervention Type DRUG

Nitrogen gas

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

Intervention Type DRUG

Oxygen gas

Supplemental oxygen administered via nasal cannula

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Participating in any other clinical trial for COVID-19
3. Pregnancy, or positive pregnancy test in a pre-dose examination.
4. Open tracheostomy.
5. Clinical contra-indication, as deemed by the PI or their designee.
6. 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.
7. Known history or clinical evidence of heart failure or left ventricular dysfunction (LVEF \< 45%).
8. Significant hemoptysis
9. Unable to provide informed consent (proxy consent is acceptable if available)
10. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No