Status:
TERMINATED
Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of Alabama at Birmingham
Conditions:
Coronavirus Infections
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no p...
Detailed Description
To date, no targeted therapeutic treatments for the ongoing COVID-19 outbreak have been identified. Antiviral combined with adjuvant therapies are currently under investigation. The clinical spectrum ...
Eligibility Criteria
Inclusion
- Laboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen and/or detection of SARS-CoV-2 IgM/IgG antibodies.
- Hospital admission with at least one of the following:
- fever ≥ 36.6 °C from axillary site; or ≥ 37.2°C from oral site; or ≥ 37.6°C from tympanic or rectal site.
- Respiratory rate ≥ 24 bpm
- cough
- Spontaneous breathing with or without hypoxia of any degree. Gas exchange and ventilation maybe assisted by any continuous continuous airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O.
Exclusion
- Tracheostomy
- Therapy with high flow nasal cannula
- Any clinical contraindications, as judged by the attending physician
- Patients enrolled in another interventional study
- Hospitalized and confirmed diagnosis of COVID-19 for more than 72 hours
- Previous intubation for COVID-19
- Patient not committed to full support (DNR, DNI or CMO)
- Patient requiring oxygen at home for lung comorbidities
- Primary cause of hopitalization not due to COVID-19
Key Trial Info
Start Date :
March 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04305457
Start Date
March 21 2020
End Date
August 23 2023
Last Update
December 17 2025
Active Locations (3)
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1
Providence HealthCare Network
Anchorage, Alaska, United States, 99508
2
Louisiana State University Health Shreveport
Shreveport, Louisiana, United States, 71103
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2621