NCT04334928: EPICOS

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

Completed Phase 3 Last updated 16 September 2021

What this trial tests

Phase 3 trial testing Emtricitabine/tenofovir disoproxil in Coronavirus Infection in 1,002 participants. Completed in 11 July 2021.

Timeline

15 April 2020

Primary endpoint
25 February 2021

11 July 2021

Quick facts

Lead sponsor	Plan Nacional sobre el Sida (PNS)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,002
Start date	15 April 2020
Primary completion	25 February 2021
Estimated completion	11 July 2021
Sites	65 locations across Spain

Drugs / interventions tested

• Emtricitabine/tenofovir disoproxil
• Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
• Placebo: Emtricitabine/tenofovir disoproxil Placebo — full drug profile →
• Placebo: Hydroxychloroquine — full drug profile →

Conditions studied

• Coronavirus Infection — all drugs for Coronavirus Infection →

Sponsor

Plan Nacional sobre el Sida (PNS) — full company profile →

Who can join

Adults 18 to 70, any sex, with Coronavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Description of COVID-19 in HIV-infected individuals: a single-centre, prospective cohort.
   Vizcarra P, Pérez-Elías MJ, Quereda C, Moreno A, et al · · 2020 · cited 259× · PMID 32473657 · DOI 10.1016/s2352-3018(20)30164-8
2. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
3. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
4. Chloroquine or hydroxychloroquine for prevention and treatment of COVID-19.
   Singh B, Ryan H, Kredo T, Chaplin M, et al · · 2021 · cited 140× · PMID 33624299 · DOI 10.1002/14651858.cd013587.pub2
5. Therapeutic use of chloroquine and hydroxychloroquine in COVID-19 and other viral infections: A narrative review.
   Hashem AM, Alghamdi BS, Algaissi AA, Alshehri FS, et al · · 2020 · cited 85× · PMID 32387694 · DOI 10.1016/j.tmaid.2020.101735
6. Prophylaxis against covid-19: living systematic review and network meta-analysis.
   Bartoszko JJ, Siemieniuk RAC, Kum E, Qasim A, et al · · 2021 · cited 83× · PMID 33903131 · DOI 10.1136/bmj.n949
7. SARS-CoV-2 RNA-dependent RNA polymerase as a therapeutic target for COVID-19.
   Vicenti I, Zazzi M, Saladini F. · · 2021 · cited 77× · PMID 33475441 · DOI 10.1080/13543776.2021.1880568
8. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895