Spanish National AIDS Plan: The 4,000-Volunteer Clinical Trial Looking at Drug Cocktail to Protect Healthcare Workers

Apr 10, 2020 | Coronavirus, COVID-19, Healthcare Workers, Hydroxychloroquine, Spain

Spanish National AIDS Plan The 4,000-Volunteer Clinical Trial Looking at Drug Cocktail to Protect Healthcare Workers

The Spanish National AIDS Plan has commenced a clinical trial to assess the efficacy of a daily single dose of either tenofovir disoproxil fumarate (TDF)/Emtricitabine and a single daily dose of hydroxychloroquine versus a placebo to determine if this combination can reduce the incidence of symptomatic disease and reduce clinical severity of COVID-19 among hospital and healthcare workers aged 18 to 65 years old in Spanish public and private hospitals.

COVID-19 Equals Danger for Healthcare Workers in Spain 

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 trials 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).

The Study

Sponsored by the Spanish National AIDS Plan and supported by Effice Servicios Para la Investigacion S.L., 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 65 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.

The study commenced April 1, 2020 and runs through to July 31, 2020. The Study is being conducted at Hospital Universitario Ramón Cajal

Lead Research/Investigator

Rosa Polo, MD, PhD, Plan Nactional sobre el Sida (PNS)

Miguel Hernán, MD, PhD, Harvard School of Public Health

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