Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Dec 9;40(6):289-295.
doi: 10.1016/j.eimc.2020.10.023. Online ahead of print.

Efficacy and safety of hydroxychloroquine in healthcare professionals with mild SARS-CoV-2 infection: Prospective, non-randomized trial

[Article in English, Spanish]
Antonia Agusti  1 , Elena Guillen  1 , Alfonso Ayora  2 , Andres Anton  3 , Cristina Aguilera  1 , Xavier Vidal  1 , Cristina Andres  3 , Manuel Alonso  2 , Meritxell Espuga  2 , Juliana Esperalba  3 , Mª Queralt Gorgas  4 , Benito Almirante  5 , Esteban Ribera  6
Affiliations

Efficacy and safety of hydroxychloroquine in healthcare professionals with mild SARS-CoV-2 infection: Prospective, non-randomized trial

[Article in English, Spanish]
Antonia Agusti et al. Enferm Infecc Microbiol Clin (Engl Ed). .

Abstract
in English, Spanish

Objectives: To assess the efficacy and safety of hydroxychloroquine (HCQ) compared with no treatment in healthcare workers with mild SARS-CoV-2 infection.

Methods: Prospective, non-randomized study. All health professionals with confirmed COVID-19 between April 7 and May 6, 2020, non-requiring initial hospitalization were asked to participate. Patients who accepted treatment were given HCQ for five days (loading dose of 400mg q12h the first day followed by200mg q12h). Control group included patients with contraindications for HCQ or who rejected treatment. Study outcomes were negative conversion and viral dynamics of SARS-CoV-2, symptoms duration and disease progression.

Result: Overall, 142 patients were enrolled: 87 in treatment group and 55 in control group. The median age was 37 years and 75% were female, with few comorbidities. There were no significant differences in time to negative conversion of PCR between both groups. The only significant difference in the probability of negative conversion of PCR was observed at day 21 (18.7%, 95%CI 2.0-35.4). The decrease of SARS-CoV-2 viral load during follow-up was similar in both groups. A non significant reduction in duration of some symptoms in HCQ group was observed. Two patients with HCQ and 4 without treatment developed pneumonia. No patients required admission to the Intensive Care Unit or died. About 50% of patients presented mild side effects of HCQ, mainly diarrhea.

Conclusions: Our study failed to show a substantial benefit of HCQ in viral dynamics and in resolution of clinical symptoms in health care workers with mild COVID-19.

Objetivos: Evaluar la eficacia y seguridad de hidroxicloroquina (HCQ), en comparación con la ausencia de tratamiento en los profesionales sanitarios con infección leve por SARS-CoV-2.

Métodos: Estudio prospectivo y no aleatorio. Se solicitó su participación a todos los profesionales sanitarios con diagnóstico confirmado de COVID-19, entre el 7 de abril y el 6 de mayo de 2020, que no requirieron hospitalización inicial. Los pacientes que aceptaron el tratamiento recibieron HCQ durante cinco días (dosis de carga de 400 mg cada 12 h el primer día, y a continuación 200 mg cada 12 h). El grupo control incluyó pacientes con contraindicaciones de HCQ, o que rechazaron el tratamiento. Los resultados del estudio fueron conversión negativa y dinámica viral de SARS-CoV-2, duración de los síntomas y progresión de la enfermedad.

Resultados: En total se incluyeron 142 pacientes: 87 en el grupo de tratamiento, y 55 en el grupo control. La edad media fue de 37 años, y el 75% fueron mujeres, con pocas comorbilidades. No existieron diferencias significativas en cuanto al tiempo transcurrido hasta la conversión negativa de la PCR entre ambos grupos. La única diferencia significativa en cuanto a la probabilidad de negativización de la PCR se observó el día 21 (18,7%, IC 95% 2-35,4). El descenso de la carga viral de SARS-CoV-2 durante el seguimiento fue similar en ambos grupos. Se observó una reducción no significativa de la duración de algunos síntomas en el grupo HCQ. Dos pacientes con HCQ y cuatro sin tratamiento desarrollaron neumonía. Ningún paciente requirió ingreso en la Unidad de Cuidados Intensivos, ni hubo fallecidos. Cerca del 50% de los pacientes presentó efectos secundarios leves de HCQ, principalmente diarrea.

Conclusiones: Nuestro estudio no reflejó un beneficio sustancial de HCQ, en cuanto a dinámica viral y resolución de los síntomas clínicos en los profesionales sanitarios con infección leve por COVID-19.

Keywords: COVID-19; Healthcare workers; Hidroxicloroquina; Hydroxychloroquine; Infección por SARS-CoV-2; Outpatients; Pacientes externos; SARS-CoV-2 infection; Trabajadores sanitarios.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flow diagram of trial participants. *Absolute contraindications included: 2 patients with history of hypersensibility to hydroxichloroquine, 3 patients with retinopathy, 3 patients with psoriasis and 1 miastenia gravis.**Relative contraindications included: 2 patients with right blockage of bundle branch and 1 atopic dermatitis.
Fig. 2
Fig. 2
Kaplan–Meier curves of time to negative conversion of PCR test in HCQ group and in control group.
Fig. 3
Fig. 3
Viral dynamics: Normalized viral loads of the nasopharyngeal swab samples at different times of disease onset from patients treated with HCQ and patients without treatment, estimated with the Δ Ct method (CtN1 Cthuman RNase P). Note that higher viral loads are inversely related to Ct values.
See this image and copyright information in PMC

References

    1. Plantone D., Koudriavtseva T. Current and future use of chloroquine and hydroxychloroquine in infectious, immune, neoplastic, and neurological diseases: a mini-review. Clin Drug Investig. 2018;38:653–671. - PubMed
    1. Liu J., Cao R., Xu M., Wang X., Zhang H., Hu H., et al. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020;6:16. - PMC - PubMed
    1. Kumar R., Gupta N., Kodan P., Mittal A., Soneja M., Wig N. Battling COVID-19: using old weapons for a new enemy. Trop Dis Travel Med Vac. 2020;6:6. - PMC - PubMed
    1. Yao X., Ye F., Zhang M., Cui C., Huang B., Niu P., et al. In vitro antiviral activity and projection of optimized dosing design of hydroxychloroquine for the treatment of severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Clin Infect Dis. 2020;71:732–739. - PMC - PubMed
    1. Hernandez A.V., Roman Y.M., Pasupuleti V., Barboza J.J., White C.M. Hydroxychloroquine or chloroquine for treatment or prophylaxis of COVID-19: a living systematic review. Ann Intern Med. 2020;173:287–296. - PubMed

LinkOut - more resources