Status:
TERMINATED
Inhaled Nitric Oxide for Preventing Progression in COVID-19
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Bellerophon
Conditions:
COVID-19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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, bas...
Detailed Description
Primary Objective: • To investigate the hypothesis that inhaled NO will reduce clinical worsening of hospitalized, high-risk patients with early COVID-19 to progressive systemic de-oxygenation, intub...
Eligibility Criteria
Inclusion
- Age 18-85 years.
- Admitted to the hospital (med-surg or critical care) with dyspnea
- Diagnosis of COVID-19 based on either
- positive nasal or oral pharyngeal swab by PCR, or
- highly probable clinical picture based on clinical and CXR/CT scan
- Requiring oxygen supplementation OR O2 saturation on room air of ≤ 94%
- At least 2 of the following 4 risk factors for clinical worsening:
- Age \>= 60 years
- T2DM or pre-diabetes as evidenced by either treatment with a hypoglycemic agent or any documented HgA1c \>= 5.6
- Obesity, based on BMI \>= 30 kg/m2
- 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
- Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 hours.
- Receiving \> 5L/min flow nasal O2 to maintain O2sat greater than or equal to 92%
- Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV)
- Receiving iNO, a PDE5 inhibitor, oral or intravenous nitrates, nitroprusside, prilocaine, sulfonamides, or riociguat.
- 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.
- History of group 1 pulmonary hypertension.
- Pregnancy
- Active breast feeding
- Severe chronic kidney disease, either receiving renal replacement therapy or eGFR \< 15 ml/min/m2
- Acute kidney injury (AKI), evidenced by acute doubling of serum creatinine within previous 48 hours.
- Clinically relevant spontaneous alteration of mental state
- Inability to provide written informed consent.
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04388683
Start Date
May 12 2020
End Date
November 23 2020
Last Update
April 19 2022
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111