COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04536363

Alonso Vera Torres, MD

Alonso.Vera@fsfb.org.co

2020-09-02

Unknown

RCT

Randomized

Parallel

Open label

unclear

Treatment

inclusion criteria: - patient older than 18 years of age - covid19 diagnosis: - rt pcr for covid-19 positive in respiratory tract sample (nasopharyngeal swab, sputum, bronchoalveolar lavage) - at least 2 of the following symptoms: cough, odynophagia, dyspnea, asthenia, adynamia, gastrointestinal symptoms. - findings compatible with viral pneumonia on chest tomography or chest radiography. - risk of respiratory deterioration given by at least 1 of the following: - hypoxemia: pao2 <60 mmhg, sao2 <90% or supplemental o2 requirement to maintain sao2> 90% - call score ≥ 9 points - fr> 30 / min - pao2 / fio2 less than 200 - intubated patients without deterioration of other organs (without acute kidney injury, without elevated transaminases). - progression of radiological findings of pneumonia. - patients with moderate or severe oxygenation disorder, with diaphragm of 200-100 and <100 respectively, who require supplemental oxygen at high flow (non-rebreathing mask or high flow cannula). - complete record of medical history, allergies, and medical conditions that preclude the use of prostaglandin e1 analogs have been ruled out. - voluntary participation in the study, demonstrating fullness through informed consent.

allergy or sensitivity to peg1 analog or components arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean arterial pressure less than 65mm of mercury or bp requirement <80/50 mmhg or tam 60 mmhg with norepinephrine requirement greater than 0.1 mcg / kg / min severe hypertension defined as systolic blood pressure greater than or equal to 180 mm of mercury and / or diastolic blood pressure greater than or equal to 110 mm of mercury bradycardia defined as heart rate less than 60 beats per minute previous events of priapism or penile anatomical changes sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism hemorrhagic diathesis active peptic ulcer, trauma, or recent brain hemorrhage. abnormal pulmonary venous return with obstruction pregnancy: a pregnancy test will be performed upon admission of the patient to the study (if applicable). heart failure with nyha functional class> 1 hemodynamically relevant arrhythmia: that generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output mitral and / or aortic stenosis and / or insufficiency of either unstable angina acute myocardial infarction in the last 6 months ischemic or hemorrhagic cerebrovascular event in the last 6 months child b or c or decompensated liver cirrhosis chronic kidney disease in renal replacement therapy serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study

2

Alonso Vera Torres

18

100

None

Severe disease at enrollment

6: Severe disease at enrollment

284

Mortality

None

Phase 2

[{"arm_notes": "", "treatment_id": 1031, "treatment_name": "Prostaglandin e1", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]