COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04388683

Marvin Konstam

mkonstam@tuftsmedicalcenter.org

2020-05-14

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: age 18-85 years. admitted to the hospital (med-surg or critical care) with dyspnea diagnosis of covid-19 based on either positive nasal or oral pharyngeal swab by pcr, or highly probable clinical picture based on clinical and cxr/ct scan requiring oxygen supplementation or o2 saturation on room air of ≤ 94% at least 2 of the following 4 risk factors for clinical worsening: age >= 60 years t2dm or pre-diabetes as evidenced by either treatment with a hypoglycemic agent or any documented hga1c >= 5.6 obesity, based on bmi >= 30 kg/m2 hypertension, based on treatment with an antihypertensive medication or systolic or diastolic blood pressure measurement >= 140 or >= 90 mmhg, documented at enrollment or at any time within the prior 6 months.

intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 hours. receiving > 5l/min flow nasal o2 to maintain o2sat greater than or equal to 92% using high-flow nasal cannula (hfnc) or non-invasive ventilation (niv) receiving ino, a pde5 inhibitor, oral or intravenous nitrates, nitroprusside, prilocaine, sulfonamides, or riociguat. other major pulmonary, cardiac, such as chronic obstructive lung disease or heart failure, or systemic illness or disease involvement with potential to represent the primary driver for clinical deterioration within the next 3 days. history of group 1 pulmonary hypertension. pregnancy active breast feeding severe chronic kidney disease, either receiving renal replacement therapy or egfr < 15 ml/min/m2 acute kidney injury (aki), evidenced by acute doubling of serum creatinine within previous 48 hours. clinically relevant spontaneous alteration of mental state inability to provide written informed consent.

2

Tufts Medical Center

18

85

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

10

Number of Participants With Average Maximum Disease Severity Assessed Through 28 Days

None

Phase 2

[{"arm_notes": "", "treatment_id": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]