[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461078":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":30,"collaborators":34,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":25,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":66,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":73,"leadSponsor":75,"locationsCount":25},{"fullName":5,"class":6},"Lihir Medical Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined Regime of Fluoxetine, Prednisolone and Ivermectin","EXPERIMENTAL","Fluoxetine: 20mg tablet; 20 mg; once daily for 10 days; oral\n\nPrednisolone: 25 mg tablet; 25mg; once daily for 5 days; oral\n\nIvermectin: 3 mg tablet; 0.4 mg\u002Fkg; once daily for 5 days; oral",[13],"Drug: Combination regimen: Fluoxetine, Prednisolone, Ivermectin",{"label":15,"type":6,"description":16,"interventionNames":17},"Combination of Vitamin C and Albendazole","Vitamin C: 50 mg tablet; 1 tablet; Once daily for 10 days; Oral\n\nAlbendazole; 200 mg; 1 tablet; Once daily for 5 days; Oral\n\nVitamin C: 50 mg tablet; 0.13 tablet\u002Fkg\\*; Once daily for 5 days; Oral\n\n\\*Same number of tablets than for Ivermectin",[18],"Drug: Combination regimen: Albendazole, Vitamin C",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Combination regimen: Fluoxetine, Prednisolone, Ivermectin","Subjects will receive the following treatments:\n\nFluoxetine 20 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 09 days.\n\nPrednisolone 25 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 04 days.\n\nIvermectin 3 mg oral tablets: Tablets started right after randomization (Day 0; 400mcg\u002F kg dosing), administered once a day for 05 consecutive days.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Combination regimen: Albendazole, Vitamin C","Subjects will receive the following treatments:\n\nVitamin C 50 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 09 days.\n\nAlbendazole 200 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 04 days.\n\nVitamin C 50 mg oral tablets: Tablets started right after randomization (Day 0; 130mcg\u002F kg dosing), administered once a day for 05 consecutive days.",[15],{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Oriol Mitja","Community Health Program Director",[35,38],{"name":36,"class":37},"National Department of Health, Papua New Guinea","UNKNOWN",{"name":39,"class":6},"Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia","100461078","phase-2-use-of-a-combined-regimen-of-fluoxetine-prednisolone-and-ivermectin-in-the-treatment-of-mild-covid-19-to-prevent-disease-progression-progression-in-papua-new-guinea-100461078",false,"NCT05283954","Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea","Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression in Papua New Guinea: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n1. Adult male or female individuals of ≥18 years old.\n2. In women of childbearing potential, negative pregnancy test at inclusion\u002Fbaseline visit.\n3. 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\u002Fbaseline visit.\n4. Symptomatic with mild COVID-19 with symptoms onset date ≤ 7 days prior to inclusion\u002Fbaseline visit. Mild COVID-19, as defined per NIH: Individuals who have any of the common signs and\u002For symptoms of COVID-19 (i.e., fever, cough, sore throat, malaise, headache, muscle pain) without shortness of breath, dyspnoea, or abnormal chest imaging.\n5. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.\n6. Has understood the information provided and capable of giving informed consent.\n\nExclusion Criteria:\n\n1. If female, pregnant or breastfeeding, or planning a pregnancy during the study.\n2. Moderate COVID-19, as defined per NIH:\n\n   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.\n3. Severe or critical COVID-19, as defined per NIH:\n\n   1. Severe COVID-19: respiratory frequency \\>30 breaths per minute, SpO2 \\\u003C94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2\u002FFiO2) \\\u003C300 mmHg, or lung infiltrates \\>50%.\n   2. Critical COVID-19: respiratory failure, septic shock, and\u002For multiple organ dysfunction.\n4. History of previous confirmed SARS-CoV-2 infection.\n5. History of significantly abnormal liver function (Child Pugh C).\n6. History of chronic kidney disease (CKD) ≥ stage 4 or need of dialysis treatment.\n7. Any pre-existing condition that increases risk of thrombosis.\n8. History of allergic reactions to ivermectin, fluoxetine, prednisolone, or vitamins C, albendazole, any of its excipients.\n9. 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\u002For life-threatening events.\n\n   1. Phenytoin\n   2. Tricyclic antidepressants\n   3. Antipsychotics: phenothiazines (i.e., chlorpromazine) haloperidol and most atypical (i.e., amitriptyline, aripiprazole, brexpiprazole, risperidone).\n   4. Donepezil\n   5. Tamoxifen\n   6. Antiarrhytmics: propafenone, flecainide\n   7. Amphetamine\n10. Concomitant use of SSRIs, SNRIs, or tricyclic antidepressants, linezolid, or methylene blue (rationale: increased risk of serotonin syndrome or TCA overdose).\n11. Concomitant use of drugs that could prolong the QT interval:\n\n    1. Specific antipsychotics: ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol\n    2. Specific antibiotics: erythromycin, gatifloxacin, moxifloxacin, sparfloxacin\n    3. Class 1A antiarrhytmics: amiodarone, sotalol\n12. Concomitant use of donepezil (S1R agonist) or sertraline (S1R antagonist)\n13. Uncontrolled psychiatric disorders, or suicidal ideation.\n14. Inability to consent and\u002For comply with study protocol, in the opinion of the investigator.","ALL","18 Years","99 Years",{"count":51,"type":52},0,"ACTUAL","INTERVENTIONAL",[55,56],"PHASE2","PHASE3","The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. The overarching idea of the work proposed herein is to investigate the use of Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to evaluate a new indication for these widely available drugs. It is estimated to include 954 participants.",[59,60],"SARS-CoV2 Infection","COVID-19",[62,63,64],"Ivermectin","Fluoxetin","Prednisolone","WITHDRAWN","Lack of funding","2023-03-07",{"date":69,"type":52},"2023-03-09",{"date":71,"type":72},"2022-05-01","ESTIMATED",{"date":74,"type":72},"2022-07-30",{"name":32,"class":6}]