COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20210615002

Taweegrit Siripongboonsitti

taweegrit.sir@pccms.ac.th

2021-06-15

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

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 - lithium - 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

4

Chulabhorn Royal Academy

18

100

Thailand

Mild disease at enrollment

1: Mild disease at enrollment

296

Clinical deterioration in mild COVID-19 day 5 VAS score;Clinical deterioration in moderate COVID-19 (pneumonia) day 5 VAS score

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1511, "treatment_name": "Favipiravir+fluvoxamine", "treatment_type": "Antivirals+central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1512, "treatment_name": "Dexamethasone+favipiravir+fluvoxamine", "treatment_type": "Corticosteroids+antivirals+central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1510, "treatment_name": "Dexamethasone+favipiravir", "treatment_type": "Corticosteroids+antivirals", "pharmacological_treatment": "Pharmacological treatment"}]