Inhaled Nitric Oxide for Preventing Progression in COVID-19 (NO-COVID-19)
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|ClinicalTrials.gov Identifier: NCT04388683|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2020
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Nitric Oxide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of COVID-19 Progression Through Early Administration of Inhaled Nitric Oxide.|
|Actual Study Start Date :||May 12, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Will receive study drug treatment.
Drug: Nitric Oxide
Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
No Intervention: Control
Will receive standard of care.
- Prevention of progressive systemic de-oxygenation, with escalation to higher levels of oxygen and ventilatory support or death, assessed using a 7-point severity scale. [ Time Frame: 28 days ]Prevention of progressive systemic de-oxygenation, with escalation to higher levels of oxygen and ventilatory support or death, assessed using a 7-point severity scale (See statistical methods). Between-group differences in the average maximum disease severity assessed through 28 days, through the following severity scores: a) increased liter oxygen flow, through a high flow nasal cannula; b) non-invasive ventilation; c) intubation or institution of ECMO; or d) death.
- Prevention of progression assessed by an alternate severity scale [ Time Frame: 28 days ]
- Time to reaching maximal severity score [ Time Frame: 28 days ]
- Proportion of patients in each stage at maximum severity [ Time Frame: 28 days ]
- PaO2/FIO2 or SaO2/FIO2 ratio, measured daily [ Time Frame: 28 days ]
- Length of hospital Stay (death assigned as worst case) [ Time Frame: 28 days ]
- Frequency of Intubation, ECMO, or need to intubate with "Do Not Resuscitate" order [ Time Frame: 28 days ]
- Mortality [ Time Frame: 28 days ]
- IL6 level [ Time Frame: 7 days ]
- TNF-alpha level [ Time Frame: 7 days ]
- Fibrinogen level [ Time Frame: 7 days ]
- CRP level [ Time Frame: 7 days ]
- Ferritin Level [ Time Frame: 7 days ]
- D-dimer level [ Time Frame: 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388683
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Marvin Konstam, MD||Tufts Medical Center|