NCT04372082 (HYdILIC) is a Phase 3 clinical trial of Standard of care (SOC) in Sars-CoV2, sponsored by University Hospital, Lille.

Who is sponsoring NCT04372082?

NCT04372082 is sponsored by University Hospital, Lille.

What drugs are being tested in NCT04372082?

Interventions in NCT04372082: Standard of care (SOC), Hydroxychloroquine, Association of diltiazem and niclosamide.

Is NCT04372082 still recruiting?

NCT04372082 is currently withdrawn. Last updated 8 March 2021.

Last reviewed 2021-03-08 · How we verify

NCT04372082: HYdILIC

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

Efficacy of HYdroxychloroquine and DILtiazem-nIClosamide Combination for the Treatment of Non-severe Forms of SARS-CoV2 Infection in Patients With Co-morbidities: Multicenter, Randomized, Open-labeled Controlled Trial

Withdrawn Phase 3 Last updated 8 March 2021

What this trial tests

Phase 3 trial testing Standard of care (SOC) in Sars-CoV2. Withdrawn.

Timeline

1 May 2020

Primary endpoint
1 May 2023

1 May 2023

Quick facts

Lead sponsor	University Hospital, Lille
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Start date	1 May 2020
Primary completion	1 May 2023
Estimated completion	1 May 2023

Drugs / interventions tested

Standard of care (SOC) — full drug profile →
Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
Association of diltiazem and niclosamide — full drug profile →

Conditions studied

Sars-CoV2 — all drugs for Sars-CoV2 →

Sponsor

University Hospital, Lille

Who can join

18 and older, any sex, with Sars-CoV2. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

death
Time frame: At day 14
Composite criteria
clinical worsening (composite criteria)
Time frame: At day 14
clinical worsening defined by at least one of the NEWS score item \> 2 (temperature \>39,1°C or\<35°C, cardiac rate \>111 or ≤40 bpm, respiratory rate \> 21 or ≤8 cycles par minute, SaO2 ≤ 93% room air (if its measure is available),need of oxygen
Assisted-ventilation and/or hospitalization (composite criteria)
Time frame: At day 14

Sponsor's own description

No optimal antiviral intervention has been yet validated to treat COVID-19 disease. Comorbidities, such as older age, obesity, diabetes, history of cardiovascular diseases are associated with poor prognosis. This study aims to evaluate the efficacy of two experimental antiviral treatments, compared to standard of care (SOC), to prevent clinical worsening, hospitalization or death at day 14 in adults with documented SARS-CoV-2 infection, asymptomatic or with symptoms lasting less than 8 days, and associated comorbidities without any severity criteria of the disease at inclusion. Participants will be randomized to receive SOC alone or SOC + hydroxychloroquine 200 mg three times a day during 10 days or SOC + association of niclosamide 2 g at J1 then 500 mg two times a day with diltiazem 60 mg three times a day during 10 days. Efficacy and tolerance of each treatments will be compared across the three treatment groups during the 28 days of follow-up.

Publications & conference data

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

Comprehensive analysis of drugs to treat SARS‑CoV‑2 infection: Mechanistic insights into current COVID‑19 therapies (Review).
Nitulescu GM, Paunescu H, Moschos SA, Petrakis D, et al · · 2020 · cited 93× · PMID 32468014 · DOI 10.3892/ijmm.2020.4608
Short linear motif candidates in the cell entry system used by SARS-CoV-2 and their potential therapeutic implications.
Mészáros B, Sámano-Sánchez H, Alvarado-Valverde J, Čalyševa J, et al · · 2021 · cited 69× · PMID 33436497 · DOI 10.1126/scisignal.abd0334
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
Niclosamide-A promising treatment for COVID-19.
Singh S, Weiss A, Goodman J, Fisk M, et al · · 2022 · cited 64× · PMID 35348204 · DOI 10.1111/bph.15843
Therapeutics for COVID-19 and post COVID-19 complications: An update.
Basu D, Chavda VP, Mehta AA. · · 2022 · cited 44× · PMID 35136858 · DOI 10.1016/j.crphar.2022.100086
Old Drugs for a New Virus: Repurposed Approaches for Combating COVID-19.
Saul S, Einav S. · · 2020 · cited 43× · PMID 32687696 · DOI 10.1021/acsinfecdis.0c00343
SARS-CoV-2, ACE2, and Hydroxychloroquine: Cardiovascular Complications, Therapeutics, and Clinical Readouts in the Current Settings.
Kalra RS, Tomar D, Meena AS, Kandimalla R. · · 2020 · cited 30× · PMID 32645974 · DOI 10.3390/pathogens9070546
2-Deoxy-D-Glucose and its Derivatives for the COVID-19 Treatment: An Update.
Huang Z, Chavda VP, Vora LK, Gajjar N, et al · · 2022 · cited 29× · PMID 35496298 · DOI 10.3389/fphar.2022.899633

Verify or expand the search:

Other trials of Standard of care (SOC)

Trials testing the same drug.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT05996471 — A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) · Phase 2 · active not recruiting
NCT04951856 — Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI · Phase 4 · active not recruiting
NCT04996264 — Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite · Phase 2 · completed
NCT04608214 — Evaluation of Alisporivir for the Treatment of Hospitalised Patients With Infections Due to SARS-CoV-2 (COVID-19) · Phase 2 · completed

Other recruiting trials for Sars-CoV2

Currently open trials in the same condition.

NCT04466683 — Low-Dose Radiotherapy For Patients With SARS-COV-2 (COVID-19) Pneumonia · Phase 2 · active not recruiting
NCT04433364 — COPE - COVID-19 in Pregnancy and Early Childhood · active not recruiting
NCT04363853 — Tocilizumab Treatment in Patients With COVID-19 · Phase 2 · active not recruiting
NCT04424992 — The Natural History of Hospitalized COVID-19 Patients · recruiting

Other University Hospital, Lille trials

Trials by the same sponsor.

NCT07528664 — Assessement of a Test a Financial-incentive Program for Pregnant Women and Their Smoking Partners to Reduce Smoking Duri · NA · not yet recruiting
NCT07434739 — PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies · NA · not yet recruiting
NCT06958224 — Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers · NA · not yet recruiting
NCT07408999 — Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer · NA · not yet recruiting
NCT07492030 — Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions · not yet recruiting

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 NCT04372082 (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 University Hospital, Lille
Last refreshed: 8 March 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/NCT04372082.

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