Evidence map›Paper›PMID 36682681›Full record

Trial reportInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2023

Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ).

Susanna Naggie, Aaron Milstone, Mario Castro, Sean P Collins, Seetha Lakshmi, Deverick J Anderson, Lizbeth Cahuayme-Zuniga, Kisha Batey Turner, Lauren W Cohen, Judith Currier and 14 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04334148 (Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial), which is not on this map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT04334148 phase3completednot on this map

Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)

TypeinterventionalSponsorAdrian HernandezRan2020 to 2021Enrolled1,360ConditionsCOVID-19ArmsHydroxychloroquine, Placebo oral tablet
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 4 syntheses or guidelines pooled it, 15 citations in OpenAlex.

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  8. Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo-controlled randomized trial in healthcare workers.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023
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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

24 authors at 11 institutions in 1 country.

Susanna NaggieDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA. Electronic address: susanna.naggie@duke.edu.
Aaron MilstoneWilliamson Medical Center, Franklin, Tennessee, USA.
Mario CastroUniversity of Kansas Medical Center, Kansas City, Kansas, USA.
Sean P CollinsVanderbilt University Medical Center, Nashville, Tennessee, USA.
Seetha LakshmiUniversity of South Florida, Tampa, Florida, USA.
Deverick J AndersonDuke University Health System, Durham, North Carolina, USA.
Lizbeth Cahuayme-ZunigaBaylor Scott and White Health Medical Center, Temple, Texas, USA.
Kisha Batey TurnerVanderbilt University Medical Center, Nashville, Tennessee, USA.
Lauren W CohenDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Judith CurrierUniversity of California Los Angeles, Los Angeles, California, USA.
Elizabeth FrauloDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Anne FriedlandDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Jyotsna GargDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Anoop GeorgeTemple University, Philadelphia, Pennsylvania, USA.
Hillary MulderDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Rachel E OlsonDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Emily C O'BrienDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Russell L RothmanVanderbilt University Medical Center, Nashville, Tennessee, USA.
Elizabeth ShenkmanUniversity of Florida, Gainesville, Florida, USA.
Jack ShostakDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Christopher W WoodsDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Kevin J AnstromUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Adrian F HernandezDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
HERO Research Program
Duke University · USVanderbilt University Medical Center · USBaylor Scott & White Medical Center - Temple · USDuke University Health System · USTemple University · USUniversity of California, Los Angeles · USUniversity of Florida · USUniversity of Kansas Medical Center · USUniversity of North Carolina at Chapel Hill · USUniversity of South Florida · USWilliamson College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo determine whether hydroxychloroquine (HCQ) is safe and effective at preventing COVID-19 infections among health care workers (HCWs).

methodsIn a 1: 1 randomized, placebo-controlled, double-blind, parallel-group, superiority trial at 34 US clinical centers, 1360 HCWs at risk for COVID-19 infection were enrolled between April and November 2020. Participants were randomized to HCQ or matched placebo. The HCQ dosing included a loading dose of HCQ 600 mg twice on day 1, followed by 400 mg daily for 29 days. The primary outcome was a composite of confirmed or suspected COVID-19 clinical infection by day 30, defined as new-onset fever, cough, or dyspnea and either a positive SARS-CoV-2 polymerase chain reaction test (confirmed) or a lack of confirmatory testing due to local restrictions (suspected).

resultsStudy enrollment closed before full accrual due to recruitment challenges. The primary end point occurred in 41 (6.0%) participants receiving HCQ and 53 (7.8%) participants receiving placebo. No difference in the proportion of participants experiencing clinical infection (estimated difference of -1.8%, 95% confidence interval -4.6-0.9%, P = 0.20) was identified nor any significant safety issues.

conclusionOral HCQ taken as prescribed appeared safe among HCWs. No significant clinical benefits were observed. The study was not powered to detect a small but potentially important reduction in infection.

trial registrationNCT04334148.

Indexed as

COVID-19Pre-Exposure ProphylaxisCOVID-19 Drug TreatmentHealth PersonnelHumansHydroxychloroquineSARS-CoV-2Treatment OutcomeHydroxychloroquineCOVID-19Health care workersHydroxychloroquinePreventionTrial design

Identifiers

PMID36682681
PMCPMC9851717
OpenAlexW4317492964

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.