COVID-19 trials registries data warehouse

http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=17062

Dong Sik Jung

Not reported

2020-08-11

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

INCLUSION CRITERIA: 1. Male and female patients aged 19-85 years of age, inclusive, as of baseline/screening visit2. Confirmed coronavirus infection based on possessing at least one of the following etiologicalevidence: a. Positive real-time fluorescence polymerase chain reaction of the patient’s respiratory orblood specimens for COVID-19 nucleic acid b. Viral gene sequences in respiratory or blood specimens that are highly homologous toCOVID-19 c. Any other diagnostic test accepted by local regulatory authorities 3. Presence of severe pneumonia as evidenced by any of the following: a. Respiratory distress with RR &gt,=30 breaths/minuteb. SpO2 &lt,90&#37, on room air and at restc. PaO2/FiO2 =&lt, 250 mmHg (1mmHg = 0.133kPa) 4. Chest imaging (x-ray [XR] or computerized tomography [CT]) confirms severe pneumonia ANDshows evidence of inflammatory exudation or pleural effusion 5. Female patients of childbearing potential who are sexually active with a non-sterilized malepartner must use at least 1 highly effective method of contraception from the time of screeningand must agree to continue using such precautions for 90 days after the final dose of studydrug(s) 6. Non-sterilized males who are sexually active with a female partner of childbearing potential mustuse condom plus spermicide from day 1 through 90 days after receipt of the last dose of studydrug(s) Patients (or their legal designates), must have the capacity to understand, sign and date a voluntarywritten, informed consent form and any required authorization prior to initiation of any studyprocedure.

EXCLUSION CRITERIA: 1. Patients with vasodilatory shock, orthostatic hypotension, hypotension, or tachycardia atscreening or baseline 2. Patients experiencing cerebral hemorrhage or cerebral infarction at baseline3. Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption4. Patients taking drugs that increase risk of bleeding (e.g. anti-coagulants, anti-platelet)5. Patients taking droxidopa6. ALT/AST &gt, 5 times the upper limit of normal at baseline7. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR &lt, 30) at baseline8. Presence of other disease that may interfere with testing procedures or which in the judgementof the Investigator may interfere with trial participation or may put the patient at risk whenparticipating in this trial9. Pregnant and lactating women and those planning to get pregnant10. Known or suspected allergy to the trial drug or the relevant drugs given in the trial11. Patients who have participated in any other clinical trial/s, including a COVID-19 trial, within thepast 3 months12. The participant is, in the opinion of the PI, unlikely to comply with the clinical study protocol oris unsuitable for any other reason

2

Dong-A University Hospital

19

85

Democratic People's Republic of Korea

Severe disease at enrollment

6: Severe disease at enrollment

40

Effect on the rate of change of partial pressure of oxygen (PaO2) and PaO2/FiO2 ratio taken at baseline and measured twice daily up to 4 weeks of treatment in IP versus control group patients

Phase 2

[{"arm_notes": "", "treatment_id": 623, "treatment_name": "Ifenprodil", "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"}]