Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel (EPICOS)
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| ClinicalTrials.gov Identifier: NCT04334928 |
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Recruitment Status :
Completed
First Posted : April 6, 2020
Last Update Posted : September 16, 2021
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Sponsor:
Plan Nacional sobre el Sida (PNS)
Collaborator:
Effice Servicios Para la Investigacion S.L.
Information provided by (Responsible Party):
Plan Nacional sobre el Sida (PNS)
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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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1002 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 |
| Actual Primary Completion Date : | February 25, 2021 |
| Actual Study Completion Date : | July 11, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
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Experimental: Emtricitabine/Tenofovir
Tenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Placebo of Hydroxychloroquine 200 mg
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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 |
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Experimental: Hydroxychloroquine
Hydroxychloroquine 200 mg + Placebo of Tenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg
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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 |
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Experimental: Emtricitabine/Tenofovir+Hydroxychloroquine
Tenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Hydroxychloroquine 200 mg
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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. |
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Placebo Comparator: Placebo
Placebo of Tenofovir Disoproxil Fumarate 245 mg/Emtricitabine 200 mg + Placebo of Hydroxychloroquine 200 mg
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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 :
- Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19) [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- 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
- 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.
| 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
Locations
Show 65 study locations
Sponsors and Collaborators
Plan Nacional sobre el Sida (PNS)
Effice Servicios Para la Investigacion S.L.
Investigators
| Study Chair: | Rosa Polo, MD,PhD | Plan Nacional sobre el Sida (PNS) | |
| Study Chair: | Miguel Hernán, MD,PhD | Harvard School of Public Health (HSPH) |
| 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: | September 16, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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):
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COVID-19 SARS-CoV-2 |
Additional relevant MeSH terms:
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Infections COVID-19 Coronavirus Infections Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases 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-HIV Agents Anti-Retroviral Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Antirheumatic Agents |