NCT04304053 (HCQ4COV19) is a Phase 3 clinical trial of Treatment and prophylaxis in COVID-19, sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia.

What drugs are being tested in NCT04304053?

Interventions in NCT04304053: Treatment and prophylaxis, Standard Public Health measures.

Is NCT04304053 still recruiting?

NCT04304053 is currently completed. Last updated 30 June 2020.

Last reviewed 2020-06-30 · How we verify

NCT04304053: HCQ4COV19

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention

Completed Phase 3 Last updated 30 June 2020

What this trial tests

Phase 3 trial testing Treatment and prophylaxis in COVID-19 in 2,300 participants. Completed in 15 June 2020.

Timeline

18 March 2020

Primary endpoint
15 June 2020

15 June 2020

Quick facts

Lead sponsor	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	2,300
Start date	18 March 2020
Primary completion	15 June 2020
Estimated completion	15 June 2020
Sites	1 location across Spain

Drugs / interventions tested

Treatment and prophylaxis — full drug profile →
Standard Public Health measures

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia — full company profile →

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a research project to evaluate the efficacy of hydroxychloroquine for post-exposure prophylaxis and early treatment of Covid-19. The intervention entails administering prophylactic hydroxychloroquine to all contacts (Study 1) and treating non severe confirmed cases with hydroxychloroquine (Study 2).

Publications & conference data

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

The epidemiology, diagnosis and treatment of COVID-19.
Zhai P, Ding Y, Wu X, Long J, et al · · 2020 · cited 461× · PMID 32234468 · DOI 10.1016/j.ijantimicag.2020.105955
COVID-19: Transmission, prevention, and potential therapeutic opportunities.
Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
Transmission of COVID-19 in 282 clusters in Catalonia, Spain: a cohort study.
Marks M, Millat-Martinez P, Ouchi D, Roberts CH, et al · · 2021 · cited 293× · PMID 33545090 · DOI 10.1016/s1473-3099(20)30985-3
A Comprehensive Literature Review on the Clinical Presentation, and Management of the Pandemic Coronavirus Disease 2019 (COVID-19).
Kakodkar P, Kaka N, Baig MN. · · 2020 · cited 255× · PMID 32269893 · DOI 10.7759/cureus.7560
Chloroquine and hydroxychloroquine in the treatment of COVID-19 with or without diabetes: A systematic search and a narrative review with a special reference to India and other developing countries.
Singh AK, Singh A, Shaikh A, Singh R, et al · · 2020 · cited 250× · PMID 32247211 · DOI 10.1016/j.dsx.2020.03.011
Ongoing Clinical Trials for the Management of the COVID-19 Pandemic.
Lythgoe MP, Middleton P. · · 2020 · cited 247× · PMID 32291112 · DOI 10.1016/j.tips.2020.03.006
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
Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.
Axfors C, Schmitt AM, Janiaud P, Van't Hooft J, et al · · 2021 · cited 217× · PMID 33859192 · DOI 10.1038/s41467-021-22446-z

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia trials

Trials by the same sponsor.

NCT07264686 — Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG - Second Trial · Phase 2 · active not recruiting
NCT07267390 — Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts · recruiting
NCT07197164 — Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients · Phase 2 · recruiting
NCT06766825 — Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC) · Phase 2 · recruiting
NCT06690814 — Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04304053 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Last refreshed: 30 June 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04304053.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing