Evidence map›Paper›PMID 35690556›Full record

Trial reportArab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology2022

Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.

Mohammed A Medhat, Mohamed El-Kassas, Haidi Karam-Allah, Ahmed Al Shafie, Sherief Abd-Elsalam, Ehab Moustafa, Sahar M Hassany, Marwa Salama, Mohamed S Abd Elghafar, Hamdy Sayed and 10 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
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

20 authors at 6 institutions in 1 country.

Mohammed A MedhatTropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.
Mohamed El-KassasEndemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt. Electronic address: m_elkassas@hq.helwan.edu.eg.
Haidi Karam-AllahTropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.
Ahmed Al ShafieEndemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Sherief Abd-ElsalamTropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Ehab MoustafaTropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.
Sahar M HassanyTropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.
Marwa SalamaTropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Mohamed S Abd ElghafarAnesthesia, Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Hamdy SayedEndemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Mohamed BadrCritical Care Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Dalia T KamalClinical Pathology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.
Ahmed ShamseldeenCritical Care Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Ashima'a OssimiCritical Care Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Inas MoazEpidemiology and Preventive Medicine Department, National Liver Institute, Menoufia University, Menoufia, Egypt.
Hossam El-Deen EsmaelTropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.
Azza M Ezz EldinClinical Pathology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.
Sameera EzzatEpidemiology and Preventive Medicine Department, National Liver Institute, Menoufia University, Menoufia, Egypt.
Hossam AbdelghaffarSupreme Council of University Hospitals, Egypt.
Khaled AbdelghaffarMinistry of Higher Education and Scientific Research, Egypt.
Assiut University · EGHelwan University · EGTanta University · EGMenoufia University · EGMinistry of Higher Education · EGSupreme Council of Antiquities · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND STUDY

aimsCurrently, there is no therapy approved for COVID-19. We evaluated the efficacy and safety of sofosbuvir/ledipasvir and nitazoxanide for the treatment of patients with COVID-19 infection. PATIENTS AND

methodsA multicenter, open-label randomized controlled trial included one hundred and ninety patients with non-severe COVID-19 infection. Patients were randomized into three groups. All groups received standard care treatment (SCT). In addition, group 1 received sofosbuvir/ledipasvir, and group 2 received nitazoxanide. Follow-up by reverse-transcriptase polymerase chain reaction (RT-PCR) was done at intervals of 5, 8, 11, and 14 days. The primary endpoint was viral clearance.

resultsViral clearance was significantly higher in the sofosbuvir/ledipasvir and nitazoxanide groups compared to the SCT group in all follow-up intervals (p < 0.001). In the sofosbuvir/ledipasvir arm, 36.9% showed early viral clearance by day 5. By day 14, 83.1% of the sofosbuvir/ledipasvir group, 39.7% of the nitazoxanide group, and 19.4% of the SCT group tested negative for SARS-CoV-2. Sofosbuvir/ledipasvir and nitazoxanide treatment were the only significant factors in Cox regression of negative RT-PCR with the highest OR (17.88, 95% CI: 6.66-47.98 and 2.59, 95% CI: 1.11-6.07, respectively). No mortality or serious adverse events were recorded.

conclusionThe addition of sofosbuvir/ledipasvir or nitazoxanide to the SCT results in an early and high viral clearance rate in mild and moderate patients with COVID-19. These drugs represent a safe and affordable treatment for COVID-19.

Indexed as

COVID-19 Drug TreatmentSofosbuvirAntiviral AgentsBenzimidazolesDrug RepositioningDrug Therapy, CombinationFluorenesGenotypeHepacivirusHumansNitro CompoundsSARS-CoV-2ThiazolesTreatment OutcomeViral LoadAntiviral AgentsBenzimidazolesFluorenesledipasvirnitazoxanideNitro CompoundsSofosbuvirThiazolesAntiviralCOVID-19NitazoxanideSARS-CoV-2Sofosbuvir/ledipasvir

Identifiers

PMID35690556
PMCPMC9116423
OpenAlexW4229074134

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.