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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002188-72 | EudraCT Number |
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evidence showed chloroquine is not effective against COVID-19
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| Name | Class |
|---|---|
| I-site University Lille North Europe | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care (SOC) | Placebo Comparator |
| |
| SOC + Hydroxychloroquine | Experimental |
| |
| SOC + Diltiazem-Niclosamide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| death | Composite criteria | 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 | At day 14 |
| Assisted-ventilation and/or hospitalization (composite criteria) | At day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at day 3, day 8, day 14 day 28 |
| cumulative incidence of hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
For all patients:
For hydroxychloroquine arm:
For diltiazem arm:
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| Name | Affiliation | Role |
|---|---|---|
| Karine Faure, MD,PhD | University Hospital, Lille | Principal Investigator |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D006886 | Hydroxychloroquine |
| D009534 | Niclosamide |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Hydroxychloroquine | Drug | 200 mg x 3 per day during 10 days in addition to SOC |
|
| Association of diltiazem and niclosamide | Drug | 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 |
|
| at day 14 |
| cumulative incidence of the use of oxygen therapy, non-invasive ventilation or invasive ventilation ( composite criteria) | at day 14 |
| Mortality | Number of patients death | at day 14 and at day 28 |
| cumulative incidence of viral shedding on SARS-CoV-2 rt-PCR on nasopharyngeal swab; | at day 3, day 8 |
| adverse drug reactions | during study, up to 28 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012458 | Salicylanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |