Sars-CoV2Phase 3HYdILICNCT04372082
Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19
A Phase 3 study testing Hydroxychloroquine and Association of diltiazem and niclosamide in people with Sars-CoV2, run by University Hospital, Lille.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- Hydroxychloroquine and Association of diltiazem and niclosamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive SARS-CoV-2 test on nasopharyngeal swab
- Onset of symptoms <8 days prior to randomization
- NEWS score<4 AND no item ≥2
- At least one comorbidity among: age ≥ 70 years old, history of cardiac disease, diabetes, obesity, chronic kidney disease, chronic respiratory failure, immunosuppression, neoplasia, liver failure (stage ≥ Child-Pugh B)
- Fully able to understand the challenges of the trial
- Signed informed consent
- Covered by Health Insurance
Who cannot join
- For all patients:
- Inability to decide to participate
- Pregnancy or breath feeding
- Hypersensitivity to any of the test drugs
- stage 4 or 5 chronic kidney disease (DFG <30 mL/min/1.73 m²)
- For hydroxychloroquine arm:
Show all 16Show fewer
- Long QT syndrome or QTc space >500 ms
- Treatment with piperazine, halofantrine, dasatinib, nilotinib, citalopram, escitalopram, hydroxyzine, domperidone
- Hepatic porphyria, retinopathy, known glucose-6-phosphate dehydrogenase deficiency,
- Heart rate <50/min
- hypokaliemia < 3.5 mmol/L
- For diltiazem arm:
- Heart rate<40/min
- Sinus bradycardia, second- or third-degree atrioventricular block
- Left heart insufficiency with pulmonary stasis
- Treatment with dantrolene, pimozide, dihydroergotamine, ergotamine, nifedipine, ivabradine, esmolol, bêta-blockers (bisoprolol, carvedilol, metoprolol, nebivolol), fingolimod
About this study
Official title: 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
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.
- Conditions
- Sars-CoV2
- Being tested
- Standard of care (SOC), Hydroxychloroquine, Association of diltiazem and niclosamide
- Keywords
- Covid-19, Hydroxychloroquine, Dilitazem, Niclosamide
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care (SOC)Other
SOC procedures including self-monitoring and medical follow-up of clinical signs and if necessary any other symptomatic treatment (paracetamol, antibiotics, steroids, oxygen…) during the whole study duration
200 mg x 3 per day during 10 days in addition to SOC
Association of diltiazem and niclosamideDrug
niclosamide 500 mg x 4 at J1 then 500 mg x 2 per day + diltiazem 60 mg x 3 per day during 10 days in addition to SOC
| Study group | Role | What they receive |
|---|---|---|
| standard of care (SOC) | Placebo comparator | Not described Receives: Other: Standard of care (SOC) |
| SOC + Hydroxychloroquine | Experimental | Not described Receives: Other: Standard of care (SOC); Drug: Hydroxychloroquine |
| SOC + Diltiazem-Niclosamide | Experimental | Not described Receives: Other: Standard of care (SOC); Drug: Association of diltiazem and niclosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Composite criteria
Measured: At day 14
clinical worsening (composite criteria)
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
Measured: At day 14
Assisted-ventilation and/or hospitalization (composite criteria)
Measured: At day 14
Secondary outcomes (6)
National Early Warning Score (NEWS)
clinical state as reflected by NEWS scoring, the clinical state of the patient regarding respiratory state as defined by the NEWS scoring system
Measured: at day 3, day 8, day 14 day 28
cumulative incidence of hospitalizations
Measured: at day 14
cumulative incidence of the use of oxygen therapy, non-invasive ventilation or invasive ventilation ( composite criteria)
Measured: at day 14
Mortality
Number of patients death
Measured: at day 14 and at day 28
cumulative incidence of viral shedding on SARS-CoV-2 rt-PCR on nasopharyngeal swab;
Measured: at day 3, day 8
adverse drug reactions
Measured: during study, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: evidence showed chloroquine is not effective against COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- I-site University Lille North Europe
- Responsible party
- Sponsor
- Investigators
- Karine Faure, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372082
- Sponsor's protocol ID
- 2020_40
- Other IDs
- 2020-002188-72
- Acronym
- HYdILIC
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04372082
- Acronym / sponsor ID
- HYdILIC / 2020_40
- Conditions
- Sars-CoV2
- Keywords
- Covid-19, Hydroxychloroquine, Dilitazem, Niclosamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: evidence showed chloroquine is not effective against COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- I-site University Lille North Europe
- Study start
- May 2020 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard of care (SOC) | Placebo comparator | Other: Standard of care (SOC) |
| SOC + Hydroxychloroquine | Experimental | Other: Standard of care (SOC), Drug: Hydroxychloroquine |
| SOC + Diltiazem-Niclosamide | Experimental | Other: Standard of care (SOC), Drug: Association of diltiazem and niclosamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Positive SARS-CoV-2 test on nasopharyngeal swab
- Onset of symptoms <8 days prior to randomization
- NEWS score<4 AND no item ≥2
- At least one comorbidity among: age ≥ 70 years old, history of cardiac disease, diabetes, obesity, chronic kidney disease, chronic respiratory failure, immunosuppression, neoplasia, liver failure (stage ≥ Child-Pugh B)
- Fully able to understand the challenges of the trial
Key exclusion criteria (16 listed)
- Inability to decide to participate
- Pregnancy or breath feeding
- Hypersensitivity to any of the test drugs
- stage 4 or 5 chronic kidney disease (DFG <30 mL/min/1.73 m²)
- Long QT syndrome or QTc space >500 ms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care (SOC)SOC procedures including self-monitoring and medical follow-up of clinical signs and if necessary any other symptomatic treatment (paracetamol, antibiotics, steroids, oxygen…) during the whole study duration | Other | SOC + Diltiazem-Niclosamide, SOC + Hydroxychloroquine, standard of care (SOC) |
| Hydroxychloroquine200 mg x 3 per day during 10 days in addition to SOC | Drug | SOC + Hydroxychloroquine |
| Association of diltiazem and niclosamideniclosamide 500 mg x 4 at J1 then 500 mg x 2 per day + diltiazem 60 mg x 3 per day during 10 days in addition to SOC | Drug | SOC + Diltiazem-Niclosamide |
Primary outcome
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
6 secondary outcomes
National Early Warning Score (NEWS)
Time frame: at day 3, day 8, day 14 day 28
cumulative incidence of hospitalizations
Time frame: at day 14
cumulative incidence of the use of oxygen therapy, non-invasive ventilation or invasive ventilation ( composite criteria)
Time frame: at day 14
Mortality
Time frame: at day 14 and at day 28
cumulative incidence of viral shedding on SARS-CoV-2 rt-PCR on nasopharyngeal swab;
Time frame: at day 3, day 8
adverse drug reactions
Time frame: during study, up to 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine Faure, MD,PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine and Association of diltiazem and niclosamide in people with Sars-CoV2, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: At day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.