Inhaled Nitric Oxide for Preventing Progression in COVID-19

• Status: Terminated
• Trial end date: 2020-11-23
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in 42 hospitalized patients with COVID-19, at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age > 60 years, type II DM, hypertension, and obesity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: Bellerophon
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. Age 18-85 years.

2. Admitted to the hospital (med-surg or critical care) with dyspnea

3. Diagnosis of COVID-19 based on either

1. positive nasal or oral pharyngeal swab by PCR, or

2. highly probable clinical picture based on clinical and CXR/CT scan

4. Requiring oxygen supplementation OR O2 saturation on room air of ≤ 94%

5. At least 2 of the following 4 risk factors for clinical worsening:

1. Age >= 60 years

2. T2DM or pre-diabetes as evidenced by either treatment with a hypoglycemic agent or any documented HgA1c >= 5.6

3. Obesity, based on BMI >= 30 kg/m2

4. Hypertension, based on treatment with an antihypertensive medication or systolic or diastolic blood pressure measurement >= 140 or >= 90 mmHg, documented at enrollment or at any time within the prior 6 months.

Exclusion Criteria:

1. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 hours.

2. Receiving > 5L/min flow nasal O2 to maintain O2sat greater than or equal to 92%

3. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV)

4. Receiving iNO, a PDE5 inhibitor, oral or intravenous nitrates, nitroprusside, prilocaine, sulfonamides, or riociguat.

5. Other major pulmonary, cardiac, such as chronic obstructive lung disease or heart failure, or systemic illness or disease involvement with potential to represent the primary driver for clinical deterioration within the next 3 days.

6. History of group 1 pulmonary hypertension.

7. Pregnancy

8. Active breast feeding

9. Severe chronic kidney disease, either receiving renal replacement therapy or eGFR < 15 ml/min/m2

10. Acute kidney injury (AKI), evidenced by acute doubling of serum creatinine within previous 48 hours.

11. Clinically relevant spontaneous alteration of mental state

12. Inability to provide written informed consent.