Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.
Arab J Gastroenterol
; 23(3): 165-171, 2022 Aug.
Article
en En
| MEDLINE
| ID: mdl-35690556
ABSTRACT
BACKGROUND AND STUDY AIMS:
Currently, there is no therapy approved for COVID-19. We evaluated the efficacy and safety of sofosbuvir/ledipasvir and nitazoxanide for the treatment of patients with COVID-19 infection. PATIENTS ANDMETHODS:
A multicenter, open-label randomized controlled trial included one hundred and ninety patients with non-severe COVID-19 infection. Patients were randomized into three groups. All groups received standard care treatment (SCT). In addition, group 1 received sofosbuvir/ledipasvir, and group 2 received nitazoxanide. Follow-up by reverse-transcriptase polymerase chain reaction (RT-PCR) was done at intervals of 5, 8, 11, and 14 days. The primary endpoint was viral clearance.RESULTS:
Viral clearance was significantly higher in the sofosbuvir/ledipasvir and nitazoxanide groups compared to the SCT group in all follow-up intervals (p < 0.001). In the sofosbuvir/ledipasvir arm, 36.9% showed early viral clearance by day 5. By day 14, 83.1% of the sofosbuvir/ledipasvir group, 39.7% of the nitazoxanide group, and 19.4% of the SCT group tested negative for SARS-CoV-2. Sofosbuvir/ledipasvir and nitazoxanide treatment were the only significant factors in Cox regression of negative RT-PCR with the highest OR (17.88, 95% CI 6.66-47.98 and 2.59, 95% CI 1.11-6.07, respectively). No mortality or serious adverse events were recorded.CONCLUSION:
The addition of sofosbuvir/ledipasvir or nitazoxanide to the SCT results in an early and high viral clearance rate in mild and moderate patients with COVID-19. These drugs represent a safe and affordable treatment for COVID-19.Palabras clave
Texto completo:
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Bases de datos:
MEDLINE
Asunto principal:
Sofosbuvir
/
Tratamiento Farmacológico de COVID-19
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Revista:
Arab J Gastroenterol
Año:
2022
Tipo del documento:
Article
País de afiliación:
Egipto