COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05283954

Oriol Mitja

Not reported

2022-03-17

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: adult male or female individuals of ≥18 years old. in women of childbearing potential, negative pregnancy test at inclusion/baseline visit. has confirmed sars-cov-2 infection as determined by pcr, a validated naat (i.e., genexpert), or validated antigen rapid diagnostic test from nasopharyngeal swabs ≤5 days prior to inclusion/baseline visit. symptomatic with mild covid-19 with symptoms onset date ≤ 7 days prior to inclusion/baseline visit. mild covid-19, as defined per nih: individuals who have any of the common signs and/or symptoms of covid-19 (i.e., fever, cough, sore throat, malaise, headache, muscle pain) without shortness of breath, dyspnoea, or abnormal chest imaging. willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. has understood the information provided and capable of giving informed consent.

if female, pregnant or breastfeeding, or planning a pregnancy during the study. moderate covid-19, as defined per nih: a. moderate covid-19: individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (spo2) ≥94% on room air at sea level. severe or critical covid-19, as defined per nih: severe covid-19: respiratory frequency >30 breaths per minute, spo2 <94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <300 mmhg, or lung infiltrates >50%. critical covid-19: respiratory failure, septic shock, and/or multiple organ dysfunction. history of previous confirmed sars-cov-2 infection. history of significantly abnormal liver function (child pugh c). history of chronic kidney disease (ckd) ≥ stage 4 or need of dialysis treatment. any pre-existing condition that increases risk of thrombosis. history of allergic reactions to ivermectin, fluoxetine, prednisolone, or vitamins c, albendazole, any of its excipients. concomitant use of medications that are highly dependent of cyp 2d6 for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events. phenytoin tricyclic antidepressants antipsychotics: phenothiazines (i.e., chlorpromazine) haloperidol and most atypical (i.e., amitriptyline, aripiprazole, brexpiprazole, risperidone). donepezil tamoxifen antiarrhytmics: propafenone, flecainide amphetamine concomitant use of ssris, snris, or tricyclic antidepressants, linezolid, or methylene blue (rationale: increased risk of serotonin syndrome or tca overdose). concomitant use of drugs that could prolong the qt interval: specific antipsychotics: ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol specific antibiotics: erythromycin, gatifloxacin, moxifloxacin, sparfloxacin class 1a antiarrhytmics: amiodarone, sotalol concomitant use of donepezil (s1r agonist) or sertraline (s1r antagonist) uncontrolled psychiatric disorders, or suicidal ideation. inability to consent and/or comply with study protocol, in the opinion of the investigator.

2

Oriol Mitja

18

99

None

Mild disease at enrollment

1: Mild disease at enrollment

0

COVID-19 disease progression;SARS-CoV-2 viral load

None

Phase 2/Phase 3

[{"arm_notes": "nan", "treatment_id": 2389, "treatment_name": "Albendazole+vitamin c", "treatment_type": "Antiparasitics+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2387, "treatment_name": "Fluoxetine+ivermectin+prednisolone", "treatment_type": "Central nervous system agents+antiparasitics+corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]