Status:
COMPLETED
Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel
Lead Sponsor:
Plan Nacional sobre el Sida (PNS)
Collaborating Sponsors:
Effice Servicios Para la Investigacion S.L.
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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), ...
Detailed Description
Healthcare workers are particularly at risk of SARS-CoV-2. In the absence of a vaccine, other strategies aiming to reduce the development of COVID-19 in the population, more specifically in healthcare...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2021
Estimated Enrollment :
1002 Patients enrolled
Trial Details
Trial ID
NCT04334928
Start Date
April 15 2020
End Date
July 11 2021
Last Update
September 16 2021
Active Locations (65)
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1
Hospital Universitario de Ferrol
Ferrol, A Coruña, Spain
2
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
3
Hospital General de Elche
Elche, Alicante, Spain
4
Hospital Sant Joan de Deu de Esplugues
Esplugues de Llobregat, Barcelona, Spain