NCT04318015 (PHYDRA) is a Phase 3 clinical trial of Hydroxychloroquine in COVID-19, sponsored by National Institute of Respiratory Diseases, Mexico.

Who is sponsoring NCT04318015?

NCT04318015 is sponsored by National Institute of Respiratory Diseases, Mexico.

What drugs are being tested in NCT04318015?

Interventions in NCT04318015: Hydroxychloroquine, Placebo oral tablet.

What condition does NCT04318015 study?

NCT04318015 studies COVID-19, Severe Acute Respiratory Syndrome.

Is NCT04318015 still recruiting?

NCT04318015 is currently completed. Last updated 1 February 2022.

Last reviewed 2022-02-01 · How we verify

NCT04318015: PHYDRA

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

Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)

Completed Phase 3 Last updated 1 February 2022

What this trial tests

Phase 3 trial testing Hydroxychloroquine in COVID-19 in 289 participants. Completed in 31 March 2021.

Timeline

14 April 2020

Primary endpoint
31 December 2020

31 March 2021

Quick facts

Lead sponsor	National Institute of Respiratory Diseases, Mexico
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	289
Start date	14 April 2020
Primary completion	31 December 2020
Estimated completion	31 March 2021
Sites	1 location across Mexico

Drugs / interventions tested

Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
Placebo oral tablet — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →
Severe Acute Respiratory Syndrome — all drugs for Severe Acute Respiratory Syndrome →

Sponsor

National Institute of Respiratory Diseases, Mexico

Who can join

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

Sponsor's own description

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

Publications & conference data

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

COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options.
Guzik TJ, Mohiddin SA, Dimarco A, Patel V, et al · · 2020 · cited 927× · PMID 32352535 · DOI 10.1093/cvr/cvaa106
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
Hydroxychloroquine and COVID-19.
Sinha N, Balayla G. · · 2020 · cited 107× · PMID 32295814 · DOI 10.1136/postgradmedj-2020-137785
Prevention and management of COVID-19 among patients with diabetes: an appraisal of the literature.
Katulanda P, Dissanayake HA, Ranathunga I, Ratnasamy V, et al · · 2020 · cited 95× · PMID 32405783 · DOI 10.1007/s00125-020-05164-x
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
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
A systematic review of the prophylactic role of chloroquine and hydroxychloroquine in coronavirus disease-19 (COVID-19).
Shah S, Das S, Jain A, Misra DP, et al · · 2020 · cited 76× · PMID 32281213 · DOI 10.1111/1756-185x.13842
The current understanding and potential therapeutic options to combat COVID-19.
Pooladanda V, Thatikonda S, Godugu C. · · 2020 · cited 56× · PMID 32437797 · DOI 10.1016/j.lfs.2020.117765

Verify or expand the search:

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Trials testing the same drug.

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NCT06971744 — Autophagy Maintenance (AUTOMAIN) · Phase 2 · recruiting
NCT05841758 — Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis · Phase 4 · recruiting

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 National Institute of Respiratory Diseases, Mexico trials

Trials by the same sponsor.

NCT06511284 — Nutritional Therapy in Patients With Post-extubation Dysphagia · NA · recruiting
NCT06254001 — Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects · Phase 4 · recruiting
NCT06571942 — Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure · Phase 4 · recruiting
NCT05685641 — Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City · NA · unknown
NCT05246293 — Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease. · Phase 2 · unknown

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 NCT04318015 (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 National Institute of Respiratory Diseases, Mexico
Last refreshed: 1 February 2022

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/NCT04318015.

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