Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)

被引：13

作者：

Mobarak, Sara ^{[1
]}

Salasi, Mehdi ^{[2
]}

Hormati, Ahmad ^{[3
,4
]}

Khodadadi, Javad ^{[5
]}

Ziaee, Masood ^{[6
]}

Abedi, Farshid ^{[6
]}

Ebrahimzadeh, Azadeh ^{[6
]}

Azarkar, Zohreh ^{[6
]}

Mansour-Ghanaei, Fariborz ^{[7
]}

Joukar, Farahnaz ^{[7
]}

Yeganeh, Sara ^{[8
]}

Yaghubi Kalurazi, Tofigh ^{[9
]}

Naghipour, Mohammadreza ^{[7
]}

Mehrabi, Zeinab ^{[10
]}

Bahadori, Amir Reza ^{[11
]}

Yaghoubi, Shoeleh ^{[10
]}

Moslemi, Rohollah ^{[12
]}

Abbaspour Kasgari, Hamideh ^{[13
]}

Fakheri, Hafez ^{[14
]}

Moghimi, Minoo ^{[13
]}

Shabani, Amir Mohammad ^{[13
]}

Nekoukar, Zahra ^{[13
]}

Babamahmoodi, Farhang

Davoudi Badabi, Ali Reza ^{[15
]}

Davoodi, Lotfollah ^{[15
]}

Hassaniazad, Mehdi ^{[16
]}

Barahimi, Elham ^{[16
]}

Tousi, Abdolali ^{[17
]}

Sadeghi, Anahita ^{[18
]}

Hosamirudsari, Hadiseh ^{[19
]}

Ali Asgari, Ali ^{[18
]}

Abdollahi, Mohammad ^{[18
]}

Anushiravani, Amir ^{[18
]}

Shabani, Minoosh ^{[20
]}

Shokouhi, Shervin ^{[20
]}

Khajavirad, Nasim ^{[21
]}

Salehi, Mohammadreza ^{[19
]}

Dehghan Manshadi, Seyed Ali ^{[19
]}

Mousavi, Hashem ^{[18
]}

Zolfaghari, Farnaz ^{[22
]}

Azimi, Elmira ^{[18
]}

Zeinali, Aida ^{[23
]}

Akbarpour, Elham ^{[18
]}

Merat, Dorsa ^{[18
]}

Eslami, Gholamali ^{[1
]}

Mousaviasl, Sajedeh ^{[1
]}

Sayar, Sara ^{[1
]}

Radmanesh, Esmat ^{[1
]}

Ebrahimzadeh, Mona ^{[1
]}

Arizavi, Zahra ^{[1
]}

机构：

[1] Abadan Univ Med Sci, Abadan, Iran

[2] Imam Khomeini Hosp Abadan Petr Hlth Org, Abadan, Iran

[3] Iran Univ Med Sci, Colorectal Res Ctr, Tehran, Iran

[4] Qom Univ Med Sci, Gastroenterol & Hepatol Dis Res Ctr, Qom, Iran

[5] Qom Univ Med Sci, Dept Infect Dis, Qom, Iran

[6] Birjand Univ Med Sci, Infect Dis Res Ctr, Birjand, Iran

[7] Guilan Univ Med Sci, Gastrointestinal & Liver Dis Res Ctr, Rasht, Iran

[8] Guilan Univ Med Sci, Caspian Digest Dis Res Ctr, Rasht, Iran

[9] Guilan Univ Med Sci, Dept Hlth Nutr & Infect Dis, Rasht, Iran

[10] Shiraz Univ Med Sci, Dept Infect Dis, Shiraz, Iran

[11] Shiraz Univ Med Sci, Student Res Comm, Shiraz, Iran

[12] Shiraz Univ Med Sci, Dept Clin Pharm, Shiraz, Iran

[13] Mazandaran Univ Med Sci, Dept Clin Pharm, Sari, Iran

[14] Mazandaran Univ Med Sci, Noncommunicable Dis Inst, Gut & Liver Res Ctr, Sari, Iran

[15] Mazandaran Univ Med Sci, Communicable Dis Inst, Antimicrobial Resistance Res Ctr, Sari, Iran

[16] Hormozgan Univ Med Sci, Infect & Trop Dis Res Ctr, Bandar Abbas, Iran

[17] Hormozgan Univ Med Sci, Student Res Comm, Bandar Abbas, Iran

[18] Univ Tehran Med Sci, Digest Dis Res Inst, Tehran, Iran

[19] Univ Tehran Med Sci, Dept Infect Dis, Tehran, Iran

[20] Shahid Beheshti Univ Med Sci, Loghman Hakim Hosp, Dept Infect Dis & Trop Med, Tehran, Iran

[21] Univ Tehran Med Sci, Dept Internal Med, Tehran, Iran

[22] Shahid Beheshti Univ Med Sci, Sch Med, Student Res Comm, Tehran, Iran

[23] Univ Tehran Med Sci, Dept Cardiol, Tehran, Iran

[24] Fasa Univ Med Sci, Dept Infect Dis, Fasa, Iran

[25] Zabol Univ Med Sci, Sch Med, Dept Biotechnol, Zabol, Iran

[26] Zabol Univ Med Sci, Sch Med, Dept Infect Dis, Zabol, Iran

[27] Zabol Univ Med Sci, Pediat Gastroenterol & Hepatol Res Ctr, Zabol, Iran

[28] Fanavaran Rojan Mohaghegh Darou Co, Dept Res & Dev, Tehran, Iran

[29] Univ Coll London Hosp, Dept Intens Care, London, England

[30] Imperial Coll London, Sch Publ Hlth, London, England

[31] Imperial Coll London, Dept Infect Dis, London, England

[32] Univ Liverpool, Dept Pharmacol & Therapeut, Liverpool, Merseyside, England

来源：

JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY | 2022年 / 77卷 / 03期

关键词：

OUTPATIENTS; SARS-COV-2; DRUGS;

D O I：

10.1093/jac/dkab433

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Background The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. Methods This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O-2 saturation Results Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95-1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77-1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. Conclusions We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.

引用

页码：758 / 766

页数：9

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