Evidence map›Paper›PMID 32812039›Full record

Trial reportThe Journal of antimicrobial chemotherapy2020

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, Ali Ali Asgari, Alireza Norouzi, Zahedin Kheiri, Amir Anushirvani, Mahnaz Montazeri, Hadiseh Hosamirudsai, Shirin Afhami, Elham Akbarpour, Rasoul Aliannejad and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 14 pooled it
3.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 14 syntheses or guidelines pooled it, 130 citations in OpenAlex.

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  5. Characteristics of published/registered clinical trials on COVID-19 treatment: A systematic review.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2021
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  7. Clinical efficacy of antiviral agents against coronavirus disease 2019: A systematic review of randomized controlled trials.Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi · 2021
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  10. Current evidence for COVID-19 therapies: a systematic literature review.European respiratory review : an official journal of the European Respiratory Society · 2021
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10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 10 institutions in 3 countries.

Anahita SadeghiLiver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Ali Ali AsgariLiver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Alireza NorouziGolestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Science, Gorgan, Iran.
Zahedin KheiriDepartment of Internal Medicine, Baharloo hospital, Tehran University of Medical Sciences, Tehran, Iran.
Amir AnushirvaniLiver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Mahnaz MontazeriDepartment of infectious diseases, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Hadiseh HosamirudsaiDepartment of Infectious Diseases, Baharloo Hospital, Tehran University of Medical Science, Tehran, Iran.
Shirin AfhamiDepartment of infectious diseases, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.
Elham AkbarpourLiver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Rasoul AliannejadDepartment of Pulmonary and Critical Care, Shariati Hospital, Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Amir Reza RadmardDepartment of Radiology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Amir H DavarpanahDepartment of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA.
Jacob LeviDepartment of Emergency Medicine, Homerton University Hospital, London, UK.
Hannah WentzelSchool of Public Health, Imperial College London, London, UK.
Ambar QaviSchool of Public Health, Imperial College London, London, UK.
Anna GarrattCardiff and Vale University Health Board, Cardiff, UK.
Bryony SimmonsDepartment of Infectious Disease, Imperial College London, London, UK.
Andrew HillDepartment of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
Shahin MeratLiver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Tehran University of Medical Sciences · IRImperial College London · GBShariati Hospital · IRUniversity of Tehran · IRCardiff and Vale University Health Board · GBEmory University · USGolestan University · IRHomerton University Hospital · GBSina Hospital · IRUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrently 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.

methodsThis 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.

resultsBetween 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.

conclusionsThe 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.

Indexed as

BetacoronavirusAdultAgedAntiviral AgentsCarbamatesCoronavirus InfectionsCOVID-19Drug Therapy, CombinationFemaleHumansImidazolesIranMaleMiddle AgedPandemicsPatient AdmissionAntiviral AgentsCarbamatesdaclatasvirImidazolesPyrrolidinesSofosbuvirValine

Identifiers

PMID32812039
PMCPMC7454592
OpenAlexW3067080207

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.