Dataset Information

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

ABSTRACT:

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, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1.

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.

SUBMITTER: Mobarak S

PROVIDER: S-EPMC8690191 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Mobarak Sara S Salasi Mehdi M Hormati Ahmad A Khodadadi Javad J Ziaee Masood M Abedi Farshid F Ebrahimzadeh Azadeh A Azarkar Zohreh Z Mansour-Ghanaei Fariborz F Joukar Farahnaz F Yeganeh Sara S Yaghubi Kalurazi Tofigh T Naghipour Mohammadreza M Mehrabi Zeinab Z Bahadori Amir Reza AR Yaghoubi Shoeleh S Moslemi Rohollah R Abbaspour Kasgari Hamideh H Fakheri Hafez H Moghimi Minoo M Shabani Amir Mohammad AM Nekoukar Zahra Z Babamahmoodi Farhang F Davoudi Badabi Ali Reza AR Davoodi Lotfollah L Hassaniazad Mehdi M Barahimi Elham E Tousi Abdolali A Sadeghi Anahita A Hosamirudsari Hadiseh H Ali Asgari Ali A Abdollahi Mohammad M Anushiravani Amir A Shabani Minoosh M Shokouhi Shervin S Khajavirad Nasim N Salehi Mohammadreza M Dehghan Manshadi Seyed Ali SA Mousavi Hashem H Zolfaghari Farnaz F Azimi Elmira E Zeinali Aida A Akbarpour Elham E Merat Dorsa D Eslami Gholamali G Mousaviasl Sajedeh S Sayar Sara S Radmanesh Esmat E Ebrahimzadeh Mona M Arizavi Zahra Z Jelvay Saeed S Salmanzadeh Shokrollah S Esmaeilian Hani H Mobarak Morteza M Karimi Jalal J Poormontaseri Zahra Z Hasooni Bahrini Nasrollah N Bonyadi Atefeh A Dehghani Fatemeh F Mirzaei Hadi H Noori Jangi Masoome M Pourmasoomi Hossein H Rezaie Keikhaie Lili L Afshari Mahdi M Nateghi Baygi Alireza A Nateghi Baygi Helia H Levi Jacob J McCann Kaitlyn K Wentzel Hannah H Simmons Bryony B Hill Andrew A Merat Shahin S

The Journal of antimicrobial chemotherapy 20220201 3

<h4>Background</h4>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.<h4>Methods</h4>This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Pati ...[more]

PMID: 34849957

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Project description:BackgroundKey findings from the World Health Organization Expert Meeting on Evaluation of Traditional Chinese Medicine (TCM) in treating coronavirus disease 2019 (COVID-19) reported that TCMs are beneficial, particularly for mild-to-moderate cases. The efficacy of Jinhua Qinggan granules (JHQG) in COVID-19 patients with mild symptoms has yet to be clearly defined.MethodsWe conducted a phase 2/3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with JHQG in mild, non-hospitalized, laboratory-confirmed COVID-19 patients. Participants were randomly assigned to receive 5 g/sacket of JHQG or placebo granules orally thrice daily for 10 days. The primary outcomes were the improvement in clinical symptoms and a proportion tested negative on viral polymerase chain reaction (PCR) after treatment. Secondary outcomes were the time to recover from clinical symptoms and changes in white blood cells (WBC) and acute phase reactants (C-reactive protein (CRP) and ferritin) on the 10th day after treatment initiation.ResultsA total of 300 patients were randomly assigned to receive JHQG (150 patients) and placebo (150 patients). Baseline characteristics were similar in the two groups. In the modified intention-to-treat analysis, JHQG showed greater clinical efficacy (82.67%) on the 10th day of the trial compared with the placebo group (10.74%; rate difference: 71.93%; 95% CI 64.09-79.76). The proportion of patients with a negative PCR after treatment was comparable (rate difference: -4.67%; 95% CI -15.76 to 6.42). In contrast, all changes in WBC, ferritin, and CRP levels showed a statistically significant decline in JHQG (P ≤ 0.044) after treatment, but not the latter in placebo (P = 0.077). The median time to recovery of COVID-19-related symptoms including cough, sputum, sore throat, dyspnea, headache, nasal obstruction, fatigue, and myalgia was shorter in the JHQG group compared to the placebo group (P < 0.001 for all). Three patients experienced mild-to-moderate adverse events (AEs) duringthe treatment period in the JHQG group. Findings were similar between the modified intention-to-treat and the per-protocol analysis that included only patients who reported 100% adherence to the assigned regimen.ConclusionBased on the time to recover from the COVID-19-related symptoms and AEs, it is concluded that JHQG is a safe and effective TCM for symptomatic relief of patients with mild COVID-19. A symptomatic improvement in the JHQG group patients was observed and JHQG use would have important public health implications in such patients.Clinical trial registrationThe Trial was prospectively registered on www.clinicaltrials.gov with registration number: NCT04723524.

Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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