Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel
EPICOS
Prevention of SARS-CoV-2 (COVID-19) Through Pre-Exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial Controlled With Placebo
1 other identifier
interventional
1,002
1 country
65
Brief Summary
Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private hospitals in Spain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2020
Shorter than P25 for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedStudy Start
First participant enrolled
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2021
CompletedSeptember 16, 2021
September 1, 2021
11 months
April 2, 2020
September 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19)
12 weeks
Secondary Outcomes (2)
Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19)
12 weeks
Duration of symptoms in confirmed infected participants of SARS-CoV-2 (COVID-19) measured in days
12 weeks
Study Arms (4)
Emtricitabine/Tenofovir
EXPERIMENTALTenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Placebo of Hydroxychloroquine 200 mg 1. Strength: 200 mg/245 mg tablets 2. Dose: one tablet once a day (both at dinner)
Hydroxychloroquine
EXPERIMENTALHydroxychloroquine 200 mg + Placebo of Tenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg 1. Strength: 200 mg tablets 2. Dose: one tablet once a day (both at dinner)
Emtricitabine/Tenofovir+Hydroxychloroquine
EXPERIMENTALTenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Hydroxychloroquine 200 mg 1. Strength FTC/TDF:200 mg/245 mg tablets 2. Strength HC: 200 mg tablets 3. Dose: one tablet FTC/TDF plus one tablet HC once a day (at dinner)
Placebo
PLACEBO COMPARATORPlacebo of Tenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Placebo of Hydroxychloroquine 200 mg 1. Placebo tablets with similar appearance to study drugs. 2. Dose: one tablet once a day (both at dinner)
Interventions
Emtricitabine/tenofovir disoproxil, 200 mg/245 mg tablets. A dose of one tablet once a day will be administered.
Hydroxychloroquine, 200 mg tablets. A dose of one tablet once a day will be administered.
Placebo: Tablets similar in appearance to Emtricitabine/tenofovir disoproxil
Placebo: Tablets similar in appearance to Hydroxychloroquine
Eligibility Criteria
You may qualify if:
- Participants that, after receiving appropriate information on the study design, objectives, possible risks and acknowledging 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 18-70years.
- Health care workers in public or private hospitals in areas of risk of SARS-CoV-2 transmission.
- No previous diagnosis of SARS-CoV-2 (COVID-19) infection plus no symptoms compatible with SARS-CoV-2 (COVID-19) since 1st of March 2020 until the date of enrolment in the study.
- Understanding of the aim of the study and, therefore, acknowledging they have not been on any drug aiming at pre exposure prophylaxis against SARS-CoV-2 (COVID-19) since 1st of March 2020. This also includes PrEP for HIV.
- 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 ( double barrier, hormonal contraception), during the study period and until 6 months after the last dose of treatment.
You may not qualify if:
- Having symptoms suggestive of COVID-19 infection
- HIV infection
- Active hepatitis B infection.
- 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 hematological disease.
- Have taken any medications such as PrEP against SARS-CoV-2 from March 1, 2020 until trial entry (also includes PrEP for HIV).
- 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.
- Breastfeeding
- Known allergy to any of the medication used in this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Hospital Universitario de Ferrol
Ferrol, A Coruña, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital General de Elche
Elche, Alicante, Spain
Hospital Sant Joan de Deu de Esplugues
Esplugues de Llobregat, Barcelona, Spain
Parc Sanitari Sant Joan de Déu de Sant Boi
Sant Boi de Llobregat, Barcelona, Spain
Hospital Moisès Broggi
Sant Joan Despí, Barcelona, 08970, Spain
Hospital Infanta Margarita
Cabra, Córdoba, Spain
Hospital Insular de Las Palmas
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Universitario de Canarias
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital de Donostia
San Sebastián, Guipuzcoa, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Principe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Fundación de Alcorcón
Alcorcón, Madrid, Spain
Hospital Colllado Villalba
Collado Villalba, Madrid, Spain
Hospital de Getafe
Getafe, Madrid, 28905, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
Hospital de Móstoles
Móstoles, Madrid, 28935, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Quirón Pozuelo
Pozuelo de Alarcón, Madrid, Spain
Hospital de Torrejón
Torrejón de Ardoz, Madrid, Spain
Hospital Infanta Elena
Valdemoro, Madrid, Spain
Hospital Virgen del Castillo
Yecla, Murcia, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Reina Sofía
Tudela, Navarre, 31500, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Arnau de Vilanova
Llíria, Valencia, Spain
Hospital de Araba
Alava, Vitoria, Spain
Hospital General Universitario de Albacete
Albacete, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, Spain
Centro Médico Teknon
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Dexeus
Barcelona, Spain
Hospital Quirón Barcelona
Barcelona, Spain
Hospital Universitario Sagrat Cor
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Virgen de la Luz
Cuenca, Spain
Hospital Clínico San Cecilio
Granada, Spain
Hospital Universitario de León
León, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Infanta Leonor
Madrid, Spain
Hospital La Princesa
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Reina Sofía
Murcia, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Complejo Asistencial de Palencia
Palencia, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital General de Segovia
Segovia, Spain
Hospital Virgen del Rocio
Seville, Spain
Hospital Virgen Macarena
Seville, Spain
Hospital Clinico Universitario
Valencia, Spain
Hospital Dr. Peset
Valencia, Spain
Hospital General de Valencia
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital de Valladolid
Valladolid, Spain
Hospital Rio Hortega
Valladolid, Spain
Hospital Lozano Blesa
Zaragoza, Spain
Hospital Miguel Servet
Zaragoza, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rosa Polo, MD,PhD
Plan Nacional sobre el Sida (PNS)
- STUDY CHAIR
Miguel Hernán, MD,PhD
Harvard School of Public Health (HSPH)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Randomized double-blind clinical trial
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2020
First Posted
April 6, 2020
Study Start
April 15, 2020
Primary Completion
February 25, 2021
Study Completion
July 11, 2021
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share