Evidence map›Paper›PMID 33525212›Full record

Trial reportActa bio-medica : Atenei Parmensis2020

Efficacy and safety of sofosbuvir/ ledipasvir in treatment of patients with COVID-19; A randomized clinical trial.

Hossein Khalili, Anahid Nourian, Zahra Ahmadinejad, Hamid Emadi Kouchak, Sirous Jafari, Sayed Ali Dehghan Manshadi, Mehrnaz Rasolinejad, Abbas Kebriaeezadeh

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Acta bio-medica : Atenei Parmensis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

21 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. 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 · 2022
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  4. 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
    Pooled it
  5. 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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  13. 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 · 2025
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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

8 authors.

Hossein KhaliliArray. khalilih@tums.ac.ir.
Anahid NourianTehran University of Medical Sciences, Tehran, Iran.. anahid.nouriam@gmail.com.
Zahra AhmadinejadTehran University of Medical Sciences, Tehran, Iran. ahmadiz@tums.ac.ir.
Hamid Emadi KouchakTehran University of Medical Sciences, Tehran, Iran. dr_emady@yahoo.com.
Sirous JafariTehran University of Medical Sciences, Tehran, Iran. jafari_sirous@yahoo.com.
Sayed Ali Dehghan ManshadiTehran University of Medical Sciences, Tehran, Iran. sealdema@yahoo.com.
Mehrnaz RasolinejadTehran University of Medical Sciences, Tehran, Iran. mehrnaz.rn@gmail.com.
Abbas KebriaeezadehTehran University of Medical Sciences, Tehran, Iran.. kebriaee@tums.ac.ir.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is no study regarding the use of SOF/LDP in treatment of COVID-19.  Objectives: In this study, the efficacy and safety of SOF/LDP were assessed in treatment of patients with mild to moderate COVID-19.

methodsAmong an open-label randomized clinical trial, 82 patients with mild to moderated COVID-19 were assigned to receive either SOF/LDP 400/100 mg daily plus the standard of care (SOF/LDP group, n=42) or the standard of care alone (control group, n=40) for 10 days. Time to clinical response, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were assessed.

resultsClinical response occurred in 91.46% of patients. Although rates of clinical response were comparable between the groups but it occurred faster in the SOF/LDP group than the control group (2 vs. 4 days respectively, P= 0.02). Supportive cares were provided in the medical wards for most patients but 17.07% of patients were transferred to ICU during the hospitalization course. However, durations of hospital and ICU stay were comparable between the groups.  14--day mortality rate was 7.14% and 7.5% in the SOF/ LDP and control groups respectively. No adverse effects leading to drug discontinuation occurred. Gastrointestinal events (nausea, vomiting and diarrhea) were the most common side effects (15.85%).

conclusionAdded to the standard of care, SOF/LDP accelerated time to the clinical response. However, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were not different. No significant adverse event was detected.  More randomized clinical trials with larger sample sizes are needed to confirm the efficacy and safety of SOF/LDP in the treatment of COVID-19.

Indexed as

COVID-19 Drug TreatmentAgedAntiviral AgentsBenzimidazolesDrug CombinationsFluorenesHumansMiddle AgedSeverity of Illness IndexSofosbuvirTreatment OutcomeAntiviral AgentsBenzimidazolesDrug CombinationsFluorenesledipasvir, sofosbuvir drug combinationSofosbuvir

Identifiers

PMID33525212
PMCPMC7927527

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.