Mild to moderate COVID-19 COVID-19, favipiravir, fluvoxamine, SARS-CoV-2, treatment
Conditions
Interventions
Fluvoxamine 100 mg per day for 10 days for mild-to-moderate COVID-19 treatment.,Standard treatment for mild-to-moderate COVID-19 treatment.
Treatment,Treatment
Fluvoxamine treatment,Standard treatment
Sponsors
Chulabhorn Royal Academy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Confirmed SARS-COV-2 infected cases by Reverse Transcriptase-Polymerase Chain Reaction who were treated with outpatients, home isolation 2. Mild to moderate illness COVID-19 3. Participants accept informed consent 4. Age >/= 18 year-old
Exclusion criteria
Exclusion criteria: 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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical non-deterioration Day 5 Proportion of Clinical non-deterioration | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory marker change 0, 2, 5, 14 days inflammatory marker change from baseline,Radiologic change Day 0, 5 Non-worsening chest X-ray infiltration,Changing of virological end-point Day 0, 5 ,14 Ct value change from baseline, negative PCR rate,Adverse events anytime descriptive of grading of AE reports,Resolution of symptoms 0, 2, 5, 14 Proportion of resolution | — |
Countries
Thailand
Contacts
Public ContactTaweegrit Siripongboonsitti
Chulabhorn Hospital, Chulabhorn Royal Academy
Outcome results
None listed