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

NCT04334928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1002

Last updated 2021-09-16

No results posted yet for this study

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.

Conditions

  • Coronavirus Infection

Interventions

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.

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

Sponsors & Collaborators

  • Effice Servicios Para la Investigacion S.L.

    collaborator INDUSTRY

  • Plan Nacional sobre el Sida (PNS)

    lead OTHER_GOV

Principal Investigators

  • Rosa Polo, MD,PhD · Plan Nacional sobre el Sida (PNS)

  • Miguel Hernán, MD,PhD · Harvard School of Public Health (HSPH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2021-02-25
Completion
2021-07-11

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04334928 on ClinicalTrials.gov