Asymptomatic COVID-19 Trial
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
Participants will be randomized into one of two treatment plans
1. Hydroxycholoquine sulfate in combination with Azithromycin Hydroxycholorquine as above, plus Azithromycine: 500 mg po for day 1and then 250 mg QD for 4 days
2. no active medication (placebo)
All participants will be followed for 2 months. The primary aim is to determine if there is any benefit (reduced likelihood for development of fever and other symptoms of COVID-19 ) to taking only Hydroxychloroquine sulfate, or to taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit to taking these medications for this population.
Ημερομηνίες
| Τελευταία επαλήθευση: | 04/30/2020 |
| Πρώτα υποβλήθηκε: | 05/01/2020 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 05/01/2020 |
| Δημοσιεύτηκε για πρώτη φορά: | 05/04/2020 |
| Υποβλήθηκε τελευταία ενημέρωση: | 05/01/2020 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 05/04/2020 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 05/04/2020 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 10/31/2020 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 03/31/2021 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Drug: Hydroxychloroquine & Azithromycin
Drug: Placebo
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Experimental: Hydroxychloroquine & Azithromycin Hydroxychloroquine sulfate 400 mg po BID for day one and then 400 mg QD for 4 days Azithromycin 500 mg po on day one, followed by 250 mg po QD X 4 days | Drug: Hydroxychloroquine & Azithromycin Drug - Hydroxychloroquine sulfate &Azithromycin |
| Placebo Comparator: Placebo Placebo for Hydroxychloroquine sulfate (2 pills bid day one and then 2 tablets QD for 4 days) Placebo for Azithromycin (2 pills on day one and followed by 1 pill po QD x 4 days) | Drug: Placebo Drug - placebo |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 20 Years Προς την 20 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: 1. Documented SARS-CoV-2 infection by qPCR assay without symptoms consistent with COVID-19 within 1 week of enrollment 2. Age ≥20 Exclusion Criteria: 1. Retinal eye disease 2. Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency 3. Known chronic kidney disease, stage 4 or 5 or receiving dialysis 4. Current use of: - Class 3 AAD - amiodarone, dronaderone, dofetilide, sotalol) - Class 1A AAD (procainamide, quinidine, disopyramide) - Flecainide - chlorpromazine - Cilostazol (Pletal) - Donepezil (Aricept) - Droperidol - Fluconazole - Methadone - Ondansetron(Zofran) - Thioridazine - Macrolides (clarithromycin, erythromycin) - Fluroquinolones (ciprofloxacin, levofloxacin, moxifloxacin) 5. Pregnancy or women who are breast feeding 6. Inability to tolerate oral medications 7. Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate 8. Allergy to adhesives 9. QTc interval > 450 mSEC for men and women 10. History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval 11. Non-English-speaking |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. The primary outcome is the rate of decline in viral load over the 10 days after randomization [10 days]
