TCTR20210615002已完成2 期
Effect of Combined Fluvoxamine with Favipiravir versus Favipiravir Monotherapy in Prevention of Clinical Deterioration among mild to moderate COVID-19 patients Monitoring by Telemedicine in Virtual Clinic: Open-label Randomized Controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 296
研究概览
简要总结
The combined fluvoxamine treatment did not add benefit in preventing deterioration in mild-to-moderate COVID-19 patients without the immunomodulatory effect observed, although it demonstrated low hospitalization rates, oxygen supplemental, intensive care needed, and zero mortality.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1) Thai people with age equal or more than 18-year-old
- •2) Confirmed COVID-19 with 1 or more of the following symptoms; fever, runny nose, cough, myalgia, sore throat, dyspnea, chest discomfort, or chest pain within 7 days after onset of illness
- •3) Asymptomatic COVID-19
- •4) Accept to perform chest CT
- •5) Communicable with staff in Thai
- •6) Accept the follow-up schedule
- •7) Nasopharyngeal swab or oropharyngeal swab detected ORF1 a/b gene E gene from SARS-CoV-2 PCR with Ct value less than 35
- •8) No meet WHO criteria for hospitalization
- •9) Accept the informed consent
排除标准
- •1)Respiratory tract symptoms compatible with a bacterial infection
- •2)Previous receiving anti-SARS-CoV-2 agents; an example of favipiravir, remdisevir, protease inhibitors within 24 hours
- •3)Complete coronavirus vaccination more than 2 weeks
- •4)History of favipiravir or fluvoxamine allergy
- •5)Need oxygen therapy
- •6)Previous use of immunosuppressive agents within 6 months; a corticosteroid, azathioprine, mycophenolate mofetil, cyclosporin, JAK inhibitor
- •7)Cannot home quarantine
- •8)Unable to receive enteral nutrition
- •9)Dyspnea or oxygen desaturation less than 95 on the initial day
- •10)Respiratory rate more than 30 per minute or BP less than 90/60 or alteration of consciousness (GCS less than 15)
- •11)Exercise-induced desaturation more than 3%
- •12)Multiorgan failure or respiratory failure
- •13)Chest CT presented infiltration of more than 50% of total lung volume (including pure GGOs) or presence of consolidation, crazy paving pattern, or ARDS pattern
- •14)Severe illness or critical illness followed Gandhi severity score
- •15)CURB-65 score more than 2, Pneumonia Severity Index more than 90
- •16)WHO clinical progression scale more than 5 or Brescia-COVID Respiratory Severity Scale (BCRSS) more than 2, or COVID-19 Severity Index more than 8, Quick COVID-19 Severity Index (qCSI) less than 1
- •17)Modified Centor score more than 2
- •18)Pregnancy or breastfeeding
- •19)Terminal illness; end-stage COPD, heart failure, end-stage renal disease, cirrhosis child C
- •20)Taking medication that had drug interaction with fluvoxamine
- •20.1) CYP1A2 substrate: agomelatine, tizanidine, aminophylline, theophylline, clozapine, caffeine, melatonin, propranolol
- •20.2) CYP2C19substrate
- •- cilostazol, melatonin
- •- fosphenytoin, phenytoin, voriconazole
- •- clopidogrel
- •- serotonergic drugs
- •- linezolid, rasagiline, selegiline
- •- antidepressants ex. sertraline, mirtazapine, amitriptyline
- •- triptans and ergots derivertives; sumatriptan, ergotamine
- •- opioids; morphine, tramadol
- •- thioridazine
- •- warfarin
- •- alprazolam, diazepam
- •- cyproheptadine
- •21)Taking the antibiotics, anti-inflammatory drug, NSAIDs, or herb within 48 hours
- •22)Depression or suicidal idea
- •23) Glaucoma
- •24) Receiving chemotherapy
- •25) Organ transplantation
- •26)Evidence of any respiratory viral infection other than coronavirus
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