tetano
Editor, Senior Moderator
J Antimicrob Chemother
. 2020 Dec 18;dkaa501.
doi: 10.1093/jac/dkaa501. Online ahead of print.
Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial
Fatemeh Roozbeh[SUP] 1 [/SUP], Majid Saeedi[SUP] 2 [/SUP], Reza Alizadeh-Navaei[SUP] 3 [/SUP], Akbar Hedayatizadeh-Omran[SUP] 3 [/SUP], Shahin Merat[SUP] 4 [/SUP], Hannah Wentzel[SUP] 5 [/SUP], Jacob Levi[SUP] 6 [/SUP], Andrew Hill[SUP] 7 [/SUP], Amir Shamshirian[SUP] 3 8 [/SUP]
Affiliations
Abstract
Introduction: Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection.
Methods: This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1.
Results: Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P < 0.001.
Conclusions: In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.
. 2020 Dec 18;dkaa501.
doi: 10.1093/jac/dkaa501. Online ahead of print.
Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial
Fatemeh Roozbeh[SUP] 1 [/SUP], Majid Saeedi[SUP] 2 [/SUP], Reza Alizadeh-Navaei[SUP] 3 [/SUP], Akbar Hedayatizadeh-Omran[SUP] 3 [/SUP], Shahin Merat[SUP] 4 [/SUP], Hannah Wentzel[SUP] 5 [/SUP], Jacob Levi[SUP] 6 [/SUP], Andrew Hill[SUP] 7 [/SUP], Amir Shamshirian[SUP] 3 8 [/SUP]
Affiliations
- PMID: 33338232
- DOI: 10.1093/jac/dkaa501
Abstract
Introduction: Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection.
Methods: This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1.
Results: Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P < 0.001.
Conclusions: In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.