COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04711863

Yong Pil Chong, M.D., Ph.D.

drchong@amc.seoul.kr

2021-01-15

Suspended

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: men and women age 18 and older laboratory-confirmed sars-cov-2 patients who have mild to moderate symptoms related to covid-19 infection and are admitted to community treatment centers in seoul, korea has symptoms consistent with covid-19 with onset ≤7 days of randomization currently symptomatic with one or more of the following symptoms: fever, cough, myalgia, shortness of breath, nausea, anorexia, diarrhea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat, headache has laboratory-confirmed sars-cov-2 infection (positive rt-pcr test) ≤ 3 days of randomization able to provide informed consent

severe illness enough to require hospitalization or already meeting the study's primary endpoint for clinical deterioration patients who cannot take oral medication pregnancy or breastfeeding history of the psychiatric disorder including major depressive disorder patients who are taking or took selective serotonin reuptake inhibitors, serotonin and noradrenaline reuptake inhibitor, or tricyclic anti-depressants within 2 weeks patients who are taking an anti-epileptic drug patients who are taking co-prescribed drugs (as below) which are contraindicated by manufacturers due to drug-drug interaction alosetron, tizanidine, theophylline, clozapine, olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by cytochrome p450 1a2) donepezil, sertraline (sigma-1 receptor agonists) warfarin (increased risk of bleeding) phenytoin (rationale: fluvoxamine inhibits its metabolism) clopidogrel (fluvoxamine inhibits its metabolism from pro-drug to active drug which raises the risk of cardiovascular events) monoamine oxidase inhibitors (linezolid, rasagiline, selegiline), triptans (sumatriptan, naratriptan, almotriptan, frovatriptan, zolmitriptan, rizatriptan), lithium, tramadol (rationale: to prevent the possible development of serotonin syndrome) alprazolam, diazepam (fluvoxamine modestly inhibits the metabolism of these drugs): the patient could be enrolled in case of agreeing 25% dose reduction of these medications. already enrolled in another covid-19 medication trial medical comorbidities such as severe underlying lung disease (chronic obstructive pulmonary disease on home oxygen, interstitial lung disease, pulmonary hypertension), decompensated cirrhosis, chronic viral hepatitis, congestive heart failure (stage 3 or 4 per patient report and/or medical records), chronic kidney disease, or end-stage renal disease requiring renal replacement therapy immunocompromised (solid organ transplant, bone-marrow transplant, acquired immune deficiency syndrome, on biologics and/or high dose steroids [>20mg prednisone per day]) unable to provide informed consent (e.g., moderate-severe dementia diagnosis) unable to perform the study procedures (self-assessment of oxygen saturation, blood pressure, and temperature using self-monitoring equipment)

2

Asan Medical Center

18

85

Korea;Republic of

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

400

Clinical deterioration

None

Phase 2

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