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This work was supported by funds from ISGlobal and Hospital Clinic's International Health's department. Laboratorios Rubio has partially contributed to the funding of this project and with hydroxychloroquine doses (Dolquine (R)). The funding body did not participate on the study design and collection, analysis, data interpretation or manuscript writing.

Analysis of institutional authors

Gonzalez-Redondo E.AuthorBarilaro GAuthorMoreno LAuthorGarcia FAuthorMuñoz JAuthor

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Article

Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial

Publicated to:Trials. 22 (1): 808- - 2021-11-15 22(1), DOI: 10.1186/s13063-021-05758-9

Authors: Grau-Pujol, Berta; Camprubi-Ferrer, Daniel; Marti-Soler, Helena; Fernandez-Pardos, Marc; Carreras-Abad, Clara; Velasco-de Andres, Maria; Ferrer, Elisabet; Muelas-Fernandez, Magdalena; Jullien, Sophie; Barilaro, Giuseppe; Ajanovic, Sara; Vera, Isabel; Moreno, Laura; Gonzalez-Redondo, Eva; Cortes-Serra, Nuria; Roldan, Montserrat; Artes-de Arcos, Ana; Mur, Isabel; Domingo, Pere; Garcia, Felipe; Guinovart, Caterina; Munoz, Jose

Affiliations

Ctr Invest Saude Manhica CISM, Maputo, Mozambique - Author
Hosp Santa Creu & Sant Pau, Infect Dis Unit, Inst Invest Biomed St Pau, Barcelona 08025, Spain - Author
Mundo Sano Fdn, Buenos Aires, DF, Argentina - Author
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain - Author
Univ Barcelona, Hosp Clin, IDIBAPS, AIDS Res Grp,Retrovirol & Viral Immunopathol, Barcelona, Spain - Author
Univ Barcelona, Hosp Clin, Infect Dis Dept, IDIBAPS, Barcelona, Spain - Author
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Abstract

Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate the efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period. Methods: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400 mg of hydroxychloroquine daily for the first four consecutive days and subsequently, 400 mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets. Results: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo arm. Given the national epidemic incidence decay, only one participant in each group was diagnosed with COVID-19. The trial was stopped due to futility and our study design was deemed underpowered to evaluate any benefit regarding PrEP efficacy. Both groups showed a similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), p=0.041). Conclusions: Although the efficacy of PrEP with hydroxychloroquine for preventing COVID-19 could not be evaluated, our study showed that PrEP with hydroxychloroquine at low doses is safe.

Keywords

controlcovid-19health-care workerspre-exposure prophylaxispreventionrheumatoid-arthritissars-cov-2Abdominal painAdultArthralgiaArticleAssaigs clínics de medicamentsChillClinical articleControlControlled studyCoronavirus disease 2019CoughingCovid-19Covid-19 drug treatmentDiarrheaDouble blind procedureDouble-blind methodDrug efficacyDrug safetyDrug testingDysgeusiaDyspneaEpidemicFemaleFeverFollow upGastrointestinal symptomHeadacheHealth care personnelHealth-care workersHumanHumansHydroxychloroquineIncidenceLow drug doseMalaiseMaleMedical personnelMedicina preventivaNasopharyngeal swabNauseaOdynophagiaPatient participationPersonal sanitariPlaceboPolymerase chain reactionPre-exposure prophylaxisPreventionPreventive medicinePruritusRandomized controlled trialRashRhinorrheaRisk factorRisk reductionSample sizeSars-cov-2Screening testSevere acute respiratory syndrome coronavirus 2Sore throatSpainSweat gland diseaseSystemic-lupus-erythematosusTreatment outcomeVisual disorder

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Trials due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2021, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Medicine (Miscellaneous).

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 9.38, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions Jun 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-06-13, the following number of citations:

  • WoS: 12
  • Scopus: 13
  • Europe PMC: 18
  • OpenCitations: 16

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-06-13:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 90.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 90 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 19.5.
  • The number of mentions on the social network X (formerly Twitter): 5 (Altmetric).
  • The number of mentions in news outlets: 2 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
  • Assignment of a Handle/URN as an identifier within the deposit in the Institutional Repository: http://hdl.handle.net/2445/185968

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Argentina; Mozambique.

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: Last Author (Muñoz García, José Esteban).