EPICOS Clinical Trial for the Prevention of Infection in Healthcare Personnel

• Status: Active, not recruiting
• Trial end date: 2020-07-31
• Target enrollment: 4000
• Participant gender: All

Summary

Having healthcare professionals affected by SARS-CoV-2 is especially relevant for several reasons. Where incidence of COVID-19 is high, participation of healthcare workers is required to be able to attend the care needs present. Sick leave and the need for isolation during 14 days dwindles the already scarce human resources available to fight the epidemic. In addition, the healthcare professionals developing asymptomatic illness could inadvertently transmit the virus to the patients being attended, contributing in this way to maintaining the epidemic among the most vulnerable population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Effice Servicios Para la Investigacion S.L.
• Collaborator: Plan Nacional sobre el Sida PNS. Ministerio de Sanidad (Sponsor)
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Hydroxychloroquine; Tenofovir

Criteria

Inclusion Criteria:

• Participants that after receiving appropriate information on the study design, objectives, possible risks and acknowledging that they have the right to withdraw from the study consent at any time sing the informed consent for participation in the study.

• Male or female aged 18-65 years.

• Health care workers in public or private hospitals in Spain in an areas of risk of SARS-CoV-2 transmission.

• Not previous diagnosis of SARS-CoV-2 (COVID-19) infection plus no symptoms of SARS-CoV-2 (COVID-19) since 1st of March 2020 until the date of enrolment in the study.

• Understand the aim of the study and have not been on any previous active pre exposure prophylaxis treatment against SARS-CoV-2 (COVID-19) since 1st of March 2020 until the date of enrolment in the study. This include PrEP for HIV.

• Negative PCR rapid test for SARS-CoV-2 (COVID-19) at enrolment.

• Participant willing and able to give informed consent for participation in the study

• Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause.

• Women of reproductive age and their partners should commit to use and highly effective contraceptive method (such sterilisation, double barrier, hormonal contraception), during the study period and until 6 months after the last dose of treatment.

Exclusion Criteria:

• HIV infection

• Active hepatitis B infection. Infección activa por virus de la hepatitis B

• Renal failure with estimated glomerular filtration rate (GFR) < 60 ml/min) and patients on Hemodialysis.

• Osteoporosis

• Myasthenia gravis

• Pre-existent maculopathy.

• Retinitis pigmentosa

• Bradycardia < 50bpm

• Weight < 40kg

• Participant with any immunosuppressive condition or haematological disease

• Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.

• Pregnancy or fertility desire during the estudy periodo r the following 6 months.

• Breastfeeding

• Known allergy to any of the medication used in this trial

• Self-medication practice to prevent SARS-2-CoV infection