Evidence map›Paper›PMID 35953881›Full record

Trial reportThe Journal of antimicrobial chemotherapy2022

Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection.

Simiso Sokhela, Bronwyn Bosch, Andrew Hill, Bryony Simmons, Joana Woods, Hilary Johnstone, Godspower Akpomiemie, Leah Ellis, Andrew Owen, Carmen Perez Casas and 1 more

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. 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
    Review
  5. Article
  6. 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

11 authors at 4 institutions in 2 countries.

Simiso SokhelaEzintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.ORCID 0000-0002-2707-1533
Bronwyn BoschEzintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Andrew HillDepartment of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
Bryony SimmonsLSE Health, London School of Economics & Political Science, London, UK.
Joana WoodsEzintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Hilary JohnstoneHJ-Clinical Trial Consultancy, George, South Africa.
Godspower AkpomiemieEzintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Leah EllisImperial College London, School of Public Health, London, UK.
Andrew OwenDepartment of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.ORCID 0000-0002-9819-7651
Carmen Perez CasasUnitaid, Global Health Campus, Chem. du Pommier 40, 1218 Le Grand-Saconnex, Switzerland.
Willem Daniel Francois VenterEzintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.ORCID 0000-0002-4157-732X
University of the Witwatersrand · ZAUniversity of Liverpool · GBImperial College London · GBLondon School of Economics and Political Science · GB

Funding

RHI 2016-07-Wits
6 · The paper itself

Abstract

backgroundThe COVER trial evaluated whether nitazoxanide or sofosbuvir/daclatasvir could lower the risk of SARS-CoV-2 infection. Nitazoxanide was selected given its favourable pharmacokinetics and in vitro antiviral effects against SARS-CoV-2. Sofosbuvir/daclatasvir had shown favourable results in early clinical trials.

methodsIn this clinical trial in Johannesburg, South Africa, healthcare workers and others at high risk of infection were randomized to 24 weeks of either nitazoxanide or sofosbuvir/daclatasvir as prevention, or standard prevention advice only. Participants were evaluated every 4 weeks for COVID-19 symptoms and had antibody and PCR testing. The primary endpoint was positive SARS-CoV-2 PCR and/or serology ≥7 days after randomization, regardless of symptoms. A Poisson regression model was used to estimate the incidence rate ratios of confirmed SARS-CoV-2 between each experimental arm and control.

resultsBetween December 2020 and January 2022, 828 participants were enrolled. COVID-19 infections were confirmed in 100 participants on nitazoxanide (2234 per 1000 person-years; 95% CI 1837-2718), 87 on sofosbuvir/daclatasvir (2125 per 1000 person-years; 95% CI 1722-2622) and 111 in the control arm (1849 per 1000 person-years; 95% CI 1535-2227). There were no significant differences in the primary endpoint between the treatment arms, and the results met the criteria for futility. In the safety analysis, the frequency of grade 3 or 4 adverse events was low and similar across arms.

conclusionsIn this randomized trial, nitazoxanide and sofosbuvir/daclatasvir had no significant preventative effect on infection with SARS-CoV-2 among healthcare workers and others at high risk of infection.

Indexed as

COVID-19Antiviral AgentsCarbamatesHumansImidazolesNitro CompoundsPyrrolidinesSARS-CoV-2SofosbuvirSouth AfricaThiazolesTreatment OutcomeValineAntiviral AgentsCarbamatesdaclatasvirImidazolesnitazoxanideNitro CompoundsPyrrolidinesSofosbuvirThiazolesValine

Identifiers

PMID35953881
PMCPMC9384711
OpenAlexW4291163584

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.