COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04398290

Roger A Alvarez, D.O.

rogeralvarez@med.miami.edu

2020-05-21

Withdrawn

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age 18 or above proven covid-19 viral infection. non-confirmed highly suspicious suspects may be enrolled. presence of radiographic findings compatible with pneumonia/pneumonitis. patients requiring at least 3 l/m oxygen via nasal canula to maintain o2 above 92%. female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). willing and able to comply with treatment schedule and study procedures.

patient with severe hypoxemia who are unable to maintain an oxygen saturation (spo2) > 88% on a maximum supplemental oxygen of 6 l/m by nasal cannula and a non-rebreather facemask. participating in any other clinical trial for covid-19 pregnancy, or positive pregnancy test in a pre-dose examination. open tracheostomy. clinical contra-indication, as deemed by the pi or their designee. use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as intravenous lidocaine, or topical benzocaine or dapsone at screening. known history or clinical evidence of heart failure or left ventricular dysfunction (lvef < 45%). significant hemoptysis unable to provide informed consent (proxy consent is acceptable if available) any of the following conditions at time of possible enrollment: fulminant liver failure, acute coronary syndrome , renal failure requiring dialysis, bacteremia, shock, cardiac arrest, cardiac arrhythmia requiring acute treatment, delirium / encephalopathy, severe disseminated intravascular coagulation, gastrointestinal hemorrhage, hypoglycemia, pneumothorax, rhabdomyolysis / myositis, seizures, or acute stroke

2

Roger Alvarez

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

Incidence of treatment emergent adverse events;Incidence of methemoglobinemia;Incidence of adverse events

None

Phase 2

[{"arm_notes": "", "treatment_id": 652, "treatment_name": "Inhaled nitric oxide (ino)", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 893, "treatment_name": "Nitrogen gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}]