Acute Respiratory Distress Syndrome Clinical Trial
— NoCovidOfficial title:
Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID-19: a Randomized Clinical Trial
Verified date | October 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Laboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen and/or detection of SARS-CoV-2 IgM/IgG antibodies. 2. Hospital admission with at least one of the following: 1. fever = 36.6 °C from axillary site; or = 37.2°C from oral site; or = 37.6°C from tympanic or rectal site. 2. Respiratory rate = 24 bpm 3. cough 3. 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 Criteria: 1. Tracheostomy 2. Therapy with high flow nasal cannula 3. Any clinical contraindications, as judged by the attending physician 4. Patients enrolled in another interventional study 5. Hospitalized and confirmed diagnosis of COVID-19 for more than 72 hours 6. Previous intubation for COVID-19 7. Patient not committed to full support (DNR, DNI or CMO) 8. Patient requiring oxygen at home for lung comorbidities 9. Primary cause of hopitalization not due to COVID-19 |
Country | Name | City | State |
---|---|---|---|
United States | Providence HealthCare Network | Anchorage | Alaska |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Louisiana State University Health Shreveport | Shreveport | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Negative conversion of COVID-19 RT-PCR from upper respiratory tract | Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or oropharyngeal swab. | 7 days | |
Primary | Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation | The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint. | 28 days | |
Secondary | Mortality | Proportion of deaths from all causes | 28 days | |
Secondary | Time to clinical recovery | Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 = 93% in room air or P/F = 300 mmHg). All these improvements must be sustained for 72 hours. | 28 days |
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