EPICOS - Experimental clinical trial for PreventIon or COronavirus in health Care professionalS

Phase 1

• Conditions: COVID-19; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001385-11-ES
• Lead Sponsor: Plan Nacional Sobre SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4000

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of a daily single dose of TDF (300 mg)/FTC (200 mg), a daily single dose of HC (200 mg), daily single dose of TDF (300 mg)/FTC (200 mg) plus HC (200 mg) or placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing the clinical severity of the coronavirus infection (COVID-19) among hospital healthcare workers aged 18 to 65 years who are exposed to coronavirus infection (COVID-19) in Spain.;Secondary Objective: not applicable;Primary end point(s): number of symptomatic confirmed infections by SARS-CoV-2 (COVID-19);Timepoint(s) of evaluation of this end point: 12 weeks treatment + 4 weeks F/

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Severity of SARS-CoV-2 infection according to the following graded classification:<br>oAsymptomatic<br>oMild symptoms: malaise, fever, cough, myalgia<br>oModerate symptoms: the symptoms above plus shortness of breath<br>oSevere symptoms: the symptoms above plus respiratory insufficiency that require mechanical respiratory support<br>•Duration, in days, of the symptoms secondary to SARS-CoV-2 infection: fever, myalgias, asthenia, shortness of breath.;Timepoint(s) of evaluation of this end point: 12 weeks treatment + 4 weeks F/