NCT04346329 (Chloroquine UN) is a Phase 3 clinical trial of Hydroxychloroquine in COVID, sponsored by Universidad Nacional de Colombia.

Who is sponsoring NCT04346329?

NCT04346329 is sponsored by Universidad Nacional de Colombia.

What drugs are being tested in NCT04346329?

Interventions in NCT04346329: Hydroxychloroquine, Placebo oral tablet.

Is NCT04346329 still recruiting?

NCT04346329 is currently withdrawn. Last updated 5 May 2021.

Last reviewed 2021-05-05 · How we verify

NCT04346329: Chloroquine UN

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

Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to COVID-19

Withdrawn Phase 3 Last updated 5 May 2021

What this trial tests

Phase 3 trial testing Hydroxychloroquine in COVID. Withdrawn.

Timeline

30 March 2020

Primary endpoint
30 June 2020

30 October 2020

Quick facts

Lead sponsor	Universidad Nacional de Colombia
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Start date	30 March 2020
Primary completion	30 June 2020
Estimated completion	30 October 2020
Sites	2 locations across Colombia

Drugs / interventions tested

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

Conditions studied

COVID — all drugs for COVID →

Sponsor

Universidad Nacional de Colombia — full company profile →

Who can join

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

Sponsor's own description

This is a PILOT STUDY, a Phase III double-blind, randomized, placebo-controlled clinical study in which we assess the clinical effect of the prophylactic administration of hydroxychloroquine vs. placebo to healthcare workers working at our University Hospital (HUN). Participants in each arm (n = 43) will be administered with a unique loading dose of 800 mg of hydroxychloroquine the first day followed by 400 mg/week for 90 days. The population to be studied (uninfected healthcare personnel) will be highly exposed to SARS-CoV-2 infection. An active search should be made for individuals who become infected while participating in the study, hence, once the informed consent form is signed, the molecular test for the diagnosis of SARS-CoV-2 infection by RT-PCR will be carried out every 4 days in order to determine as closely as possible the moment the participant becomes positive. The results of the diagnostic RT-qPCR tests will be confronted with: (i) the results of immune monitoring of at least 30 immunological parameters in leukocytes and in plasma (levels of selected cytokines and chemokines analyzed by automated flow cytometry software and (ii) the daily recording of data for the presence or absence of signs and symptoms associated with SARS-Cov-2 infection. For the recording of immune monitoring 20mL blood samples will be taken at eight-time points throughout the 90 days of the stud.

Publications & conference data

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

A review on possible modes of action of chloroquine/hydroxychloroquine: repurposing against SAR-CoV-2 (COVID-19) pandemic.
Tripathy S, Dassarma B, Roy S, Chabalala H, et al · · 2020 · cited 71× · PMID 32450198 · DOI 10.1016/j.ijantimicag.2020.106028
Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines).
Slimano F, Baudouin A, Zerbit J, Toulemonde-Deldicque A, et al · · 2020 · cited 29× · PMID 32623296 · DOI 10.1016/j.ctrv.2020.102063
Approaching coronavirus disease 2019: Mechanisms of action of repurposed drugs with potential activity against SARS-CoV-2.
Lisi L, Lacal PM, Barbaccia ML, Graziani G. · · 2020 · cited 20× · PMID 32710969 · DOI 10.1016/j.bcp.2020.114169
Hydroxychloroquine and Covid-19: A Cellular and Molecular Biology Based Update.
Pal A, Pawar A, Goswami K, Sharma P, et al · · 2020 · cited 20× · PMID 32641874 · DOI 10.1007/s12291-020-00900-x
Recent Updates in Experimental Research and Clinical Evaluation on Drugs for COVID-19 Treatment.
Zou H, Yang Y, Dai H, Xiong Y, et al · · 2021 · cited 12× · PMID 34880750 · DOI 10.3389/fphar.2021.732403
Hydroxychloroquine as Prophylaxis for Coronavirus SARS-CoV-2 Infection: Review of the Ongoing Clinical Trials.
Galvis V, Spinelli FR, Tello A, Sossa CL, et al · · 2020 · cited 8× · PMID 33994644 · DOI 10.1016/j.arbr.2020.05.010
Ethical review of off-label drugs during the COVID-19 pandemic.
Li QY, Lv Y, An ZY, Dai NN, et al · · 2022 · cited 2× · PMID 35979109 · DOI 10.12998/wjcc.v10.i17.5541
Hydroxychloroquine as Prophylaxis for Coronavirus SARS-CoV-2 Infection: Review of the Ongoing Clinical Trials Hidroxicloroquina como profilaxis para la infección por coronavirus SARS-CoV-2: revisión de los ensayos clínicos en curso
Galvis V, Spinelli F, Tello A, Sossa C, et al · · 2020

Verify or expand the search:

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Other Universidad Nacional de Colombia trials

Trials by the same sponsor.

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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 NCT04346329 (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 Universidad Nacional de Colombia
Last refreshed: 5 May 2021

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/NCT04346329.

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