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Clinical Trial
. 2020 Nov 1;75(11):3379-3385.
doi: 10.1093/jac/dkaa334.

Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial

Anahita Sadeghi  1 , Ali Ali Asgari  1 , Alireza Norouzi  2 , Zahedin Kheiri  3 , Amir Anushirvani  1 , Mahnaz Montazeri  4 , Hadiseh Hosamirudsai  5 , Shirin Afhami  6 , Elham Akbarpour  1 , Rasoul Aliannejad  7 , Amir Reza Radmard  8 , Amir H Davarpanah  9 , Jacob Levi  10 , Hannah Wentzel  11 , Ambar Qavi  11 , Anna Garratt  12 , Bryony Simmons  13 , Andrew Hill  14 , Shahin Merat  1
Affiliations
Clinical Trial

Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial

Anahita Sadeghi et al. J Antimicrob Chemother. .

Abstract

Background: Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19.

Methods: This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2.

Results: Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4-8)] than the control group [8 days (IQR 5-13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray's P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported.

Conclusions: The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.

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Figures

Figure 1.
Figure 1.
Patient flow.
Figure 2.
Figure 2.
Cause-specific cumulative incidence function by treatment arm. SOF/DCV, sofosbuvir/daclatasvir.
See this image and copyright information in PMC

References

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