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Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel (EPICOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334928
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
Effice Servicios Para la Investigacion S.L.
Information provided by (Responsible Party):
Plan Nacional sobre el Sida (PNS)

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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Emtricitabine/tenofovir disoproxil Drug: Hydroxychloroquine Drug: Placebo: Emtricitabine/tenofovir disoproxil Placebo Drug: Placebo: Hydroxychloroquine Phase 3

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 workers is being sought. Administration of effective drugs to people at risk of developing an infectious disease is well accepted and is part of clinical practice. To date there are few on-going randomized clinical trial on Pre-exposure prophylaxis (PrEP) evaluating chloroquine and hydroxychloroquine efficacy for health care workers and other groups at high risk. Existing recent and scarce literature shows that RNA synthesis nucleos(t)ide analogue inhibitors, acting as viral RNA chain terminators, like TDF, abacavir or lamivudine, amongst others, could have an effect against SARS-CoV-2 infection. Worldwide, there is broad evidence of the use, safety and tolerability of hydroxychloroquine (200 mg) and TDF/FTC (245 mg/200 mg). This study aims to assess the efficacy of a daily single dose of TDF (245 mg)/FTC (200 mg), a daily single dose of 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. Sample size calculations are based on the primary outcome; number of symptomatic confirmed infections by SARS-CoV-2. Briefly, 4.000 participants will be assigned to one of the 4 groups, through 1:1:1:1 randomization. Duration of prophylactic treatment will be 12 weeks from early April 2020 till early July 2020. Follow up of participants will continue up to 4 weeks after last dose of treatment. All participants will be assessed on a monthly basis. Interim analyses will be performed on monthly bases.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Randomized double-blind clinical trial
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Emtricitabine/Tenofovir

Tenofovir 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)
Drug: Emtricitabine/tenofovir disoproxil
Emtricitabine/tenofovir disoproxil, 200 mg/245 mg tablets. A dose of one tablet once a day will be administered.

Drug: Placebo: Hydroxychloroquine
Placebo: Tablets similar in appearance to Hydroxychloroquine

Experimental: Hydroxychloroquine

Hydroxychloroquine 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)
Drug: Hydroxychloroquine
Hydroxychloroquine, 200 mg tablets. A dose of one tablet once a day will be administered.

Drug: Placebo: Emtricitabine/tenofovir disoproxil Placebo
Placebo: Tablets similar in appearance to Emtricitabine/tenofovir disoproxil

Experimental: Emtricitabine/Tenofovir+Hydroxychloroquine

Tenofovir 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)
Drug: Emtricitabine/tenofovir disoproxil
Emtricitabine/tenofovir disoproxil, 200 mg/245 mg tablets. A dose of one tablet once a day will be administered.

Drug: Hydroxychloroquine
Hydroxychloroquine, 200 mg tablets. A dose of one tablet once a day will be administered.

Placebo Comparator: Placebo

Placebo 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)
Drug: Placebo: Emtricitabine/tenofovir disoproxil Placebo
Placebo: Tablets similar in appearance to Emtricitabine/tenofovir disoproxil

Drug: Placebo: Hydroxychloroquine
Placebo: Tablets similar in appearance to Hydroxychloroquine




Primary Outcome Measures :
  1. Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19) [ Time Frame: 12 weeks ]

    assessed by:

    • No symptoms
    • Mild symptoms: general malaise, fever, cough, myalgia, asthenia.
    • Moderate symptoms: mild symptoms plus shortness of breath,
    • Severe symptoms: mild symptoms plus respiratory insufficiency that requires admission in intensive care unit and mechanical ventilation

  2. Duration of symptoms in confirmed infected participants of SARS-CoV-2 (COVID-19) measured in days [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334928


Contacts
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Contact: Julia del Amo, MD,PhD +34 690 963030 jamo@mscbs.es; rpolor@mscbs.es
Contact: Enrique Conde +34 912948910 enrique.conde@efficeresearch.com

Locations
Show Show 65 study locations
Sponsors and Collaborators
Plan Nacional sobre el Sida (PNS)
Effice Servicios Para la Investigacion S.L.
Investigators
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Study Chair: Rosa Polo, MD,PhD Plan Nacional sobre el Sida (PNS)
Study Chair: Miguel Hernán, MD,PhD Harvard School of Public Health
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Responsible Party: Plan Nacional sobre el Sida (PNS)
ClinicalTrials.gov Identifier: NCT04334928    
Other Study ID Numbers: PrEP COVID-19
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Plan Nacional sobre el Sida (PNS):
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Hydroxychloroquine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents