Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel
Condition: Coronavirus Infection
MeSH terms: Infections; COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Emtricitabine/tenofovir disoproxil; Hydroxychloroquine; Placebo: Emtricitabine/tenofovir disoproxil Placebo; Placebo: Hydroxychloroquine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; SARS-CoV-2