Efficacy and safety of sofosbuvir/ ledipasvir in treatment of patients with COVID-19; A randomized clinical trial.
| Autor: | Khalili H; Array. khalilih@tums.ac.ir., Nourian A; Tehran University of Medical Sciences, Tehran, Iran.. anahid.nouriam@gmail.com., Ahmadinejad Z; Tehran University of Medical Sciences, Tehran, Iran. ahmadiz@tums.ac.ir., Emadi Kouchak H; Tehran University of Medical Sciences, Tehran, Iran. dr_emady@yahoo.com., Jafari S; Tehran University of Medical Sciences, Tehran, Iran. jafari_sirous@yahoo.com., Dehghan Manshadi SA; Tehran University of Medical Sciences, Tehran, Iran. sealdema@yahoo.com., Rasolinejad M; Tehran University of Medical Sciences, Tehran, Iran. mehrnaz.rn@gmail.com., Kebriaeezadeh A; Tehran University of Medical Sciences, Tehran, Iran.. kebriaee@tums.ac.ir. |
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| Jazyk: | angličtina |
| Zdroj: | Acta bio-medica : Atenei Parmensis [Acta Biomed] 2020 Nov 10; Vol. 91 (4), pp. e2020102. Date of Electronic Publication: 2020 Nov 10. |
| DOI: | 10.23750/abm.v91i4.10877 |
| Abstrakt: | Background: There is no study regarding the use of SOF/LDP in treatment of COVID-19. Objectives: In this study, the efficacy and safety of SOF/LDP were assessed in treatment of patients with mild to moderate COVID-19. Methods: Among an open-label randomized clinical trial, 82 patients with mild to moderated COVID-19 were assigned to receive either SOF/LDP 400/100 mg daily plus the standard of care (SOF/LDP group, n=42) or the standard of care alone (control group, n=40) for 10 days. Time to clinical response, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were assessed. Results: Clinical response occurred in 91.46% of patients. Although rates of clinical response were comparable between the groups but it occurred faster in the SOF/LDP group than the control group (2 vs. 4 days respectively, P= 0.02). Supportive cares were provided in the medical wards for most patients but 17.07% of patients were transferred to ICU during the hospitalization course. However, durations of hospital and ICU stay were comparable between the groups. 14--day mortality rate was 7.14% and 7.5% in the SOF/ LDP and control groups respectively. No adverse effects leading to drug discontinuation occurred. Gastrointestinal events (nausea, vomiting and diarrhea) were the most common side effects (15.85%). Conclusion: Added to the standard of care, SOF/LDP accelerated time to the clinical response. However, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were not different. No significant adverse event was detected. More randomized clinical trials with larger sample sizes are needed to confirm the efficacy and safety of SOF/LDP in the treatment of COVID-19. |
| Databáze: | MEDLINE |
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