Status:
COMPLETED
Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Xijing Hospital
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
SARS (Severe Acute Respiratory Syndrome)
Coronavirus
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Severe acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemi...
Detailed Description
Severe acute respiratory syndrome (SARS-CoV-2) due to novel Coronavirus (2019-nCoV) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxem...
Eligibility Criteria
Inclusion
- Inclusion criteria: (1) Adult patients, \>/= 18 year-old; (2) Patients admitted to the ICU; (3) Patients who are intubated and mechanically ventilated; (4) Confirmed diagnosis of SARS-CoV2 by positive rt-PCR.
- Exclusion criteria: (1) Patients intubated for more than 72 hours from initiation of the treatment gas; (2) Subjects enrolled in another interventional research study; (3) Physician of record opposed to enrolling the patient due to perceived safety concerns; or any condition that does not allow the protocol to be followed safely; (4) Subjects with past medical history of lung malignancy or pneumonectomy or lung transplant; (5) Subjects receiving a tidal volume \< 3 cc/kg of ideal body weight at the time of enrollment; (6) Subjects with severe burns involving more than 40% of Total Body Surface Area; (7) Subjects that have experienced cardiac arrest with CPR for longer than 30 minutes; (8) Subjects with a presumed severe deficit in cerebral function with fixed dilated pupil; (9) Subjects receiving renal replacement therapy at the time of enrollment; (10) Subjects who have an impaired ability to ventilate without assistance; (11) Subjects who have a history of malignancy or other irreversible disease/conditions with a 6-month mortality \> 50%; (12) Subjects not fully committed to full support at the time of enrollment; (13) Subject receiving inhaled nitric oxide gas prior to enrollment; (14) Subject's hospital admission unrelated to COVID-19.
Exclusion
Key Trial Info
Start Date :
March 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04306393
Start Date
March 21 2020
End Date
June 15 2022
Last Update
June 22 2022
Active Locations (5)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Louisiana State University Health Shreveport
Shreveport, Louisiana, United States, 71103
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215