Trial reportThe Journal of antimicrobial chemotherapy2021
Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial.
Trial report in The Journal of antimicrobial chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 10 of them syntheses that pooled 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.
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.
Who cites it
40 citing papers in PubMed, 10 syntheses or guidelines pooled it, 64 citations in OpenAlex.
- The relationship between viral clearance rates and disease progression in early symptomatic COVID-19: a systematic review and meta-regression analysis.The Journal of antimicrobial chemotherapy · 2024Pooled it
- Outpatient randomized controlled trials to reduce COVID-19 hospitalization: Systematic review and meta-analysis.Journal of medical virology · 2023Pooled it
- Prevalence, risk factors and treatments for post-COVID-19 breathlessness: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2022Pooled it
- Antiviral drug treatment for nonsevere COVID-19: a systematic review and network meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2022Pooled it
- Comparative effectiveness of pharmacological interventions on mortality and the average length of hospital stay of patients with COVID-19: a systematic review and meta-analysis of randomized controlled trials.Expert review of anti-infective therapy · 2022Pooled it
- Effect of sofosbuvir-based treatment on clinical outcomes of patients with COVID-19: a systematic review and meta-analysis of randomised controlled trials.International journal of antimicrobial agents · 2022Pooled it
- The Fragility of Statistically Significant Results in Randomized Clinical Trials for COVID-19.JAMA network open · 2022Pooled it
- Efficacy of antiviral therapies for COVID-19: a systematic review of randomized controlled trials.BMC infectious diseases · 2022Pooled it
- Characteristics of published/registered clinical trials on COVID-19 treatment: A systematic review.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2021Pooled it
- 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 · 2021Pooled it
- Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology · 2022Trial
- Efficacy and safety of sofosbuvir plus daclatasvir or ravidasvir in patients with COVID-19: A randomized controlled trial.Journal of medical virology · 2021Trial
- Antivirals in COVID-19: A Focus on Pediatric Cardiac Patients.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2025Review
- Identification of Candidate Inhibitors to SARS-CoV-2's Enzymes and Potential Disruptors of Its Structural Proteins' Interactions.Advanced biomedical research · 2025Article
- COVID-19 therapeutics.Clinical microbiology reviews · 2024Review
- Evaluating the Therapeutic Effect of Sofosbuvir in Outpatients with COVID-19: A Randomized Clinical Trial Study.Galen medical journal · 2024Article
- Hospitalization Endpoint in Clinical Trials of Outpatient Settings: using Anti-SARS-COV-2 Therapy as an Example.Clinical epidemiology · 2024Review
- Novel sofosbuvir derivatives against SARS-CoV-2 RNA-dependent RNA polymerase: an in silico perspective.Scientific reports · 2023Article
- An Update on SARS-CoV-2 Clinical Trial Results-What We Can Learn for the Next Pandemic.International journal of molecular sciences · 2023Review
- Roles of the ACE/Ang II/AT1R pathway, cytokine release, and alteration of tight junctions in COVID-19 pathogenesis.Tissue barriers · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEffective 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.
methodsThis 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.
resultsBetween 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.
conclusionsIn 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.
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Registered trials
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.