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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004160-94 | EudraCT Number |
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the epidemiological situation has changed considerably.
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| Name | Class |
|---|---|
| Signia Therapeutics | UNKNOWN |
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SARS-CoV-2 infection is responsible for hypoxemic pneumonia, which is sometimes serious and associated with excess mortality. To date, with the exception of dexamethasone, which has shown clinical efficacy by reducing the mortality of infected patients, no other therapeutic strategy has demonstrated a curative clinical benefit, particularly in the initial stages facilitating viral eviction. .
Based on the mechanism of action and the available data, diltiazem, administered in the first days post-infection, could facilitate viral eradication in these patients through the stimulation of the innate immune response of cells of the infected respiratory epithelium, actor in the fight against SARS-CoV-2.
In this context, the investigators propose the DICOV trial, to demonstrate the ability of diltiazem to reduce the viral load more rapidly, in patients hospitalized for COVID-19 hypoxemic pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Of Care (SOC) + diltiazem | Experimental | Patients will receive the standard of care at the time of their inclusion in the trial and will also receive diltiazem (60mg 3 times a day) for 7 days. |
|
| SOC + placebo | Placebo Comparator | Patients will receive the standard of care at the time of their inclusion in the trial and will also receive a diltiazem placebo (3 times a day) for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DILTIAZEM TEVA 60 mg or placebo | Drug | DILTIAZEM TEVA 60 mg 3 times a day during 7 days + standard of care Or placebo 3 times a day during 7 days + standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 viral load decrease between D1 and D7 | Dosage of the standardized SARS-CoV-2 viral load on nasopharyngeal samples on day 1 and day 7 after treatment initiation. | At day 1 and day 7 post treatment initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical improvement | Time to clinical improvement (in days), defined as the time from randomization to an improvement of at least 2 points on a 7-point ordinal scale | Within 28 days post-randomization |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
Need for hospitalization in intensive care unit at inclusion
Patient with cognitive impairment, at the discretion of the investigator
Pregnant woman (positive urine pregnancy test on inclusion) or breastfeeding
Participation in another interventional study or being in the exclusion period from a previous study
Patient on diltiazem therapy
Contraindication to diltiazem
Patient with renal, hepatic or cardiac insufficiency (at the discretion of the investigator)
Hypersensitivity to mannitol
Use of anti-COVID medications other than those offered in routine testing and care.
Presence of hemodynamic instability, systolic blood pressure < 100 mmHg, presence of multi-visceral failure
Prior respiratory pathology requiring oxygen therapy at the long-term and/or non-invasive ventilation
Immunocompromised patients (organ transplant, allograft, under chemotherapy, under Rituximab or a history of Rituximab), for any other situation seek the advice of the coordinating investigator
Patient under guardianship, curatorship or safeguard of justice
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Devouassoux, Pr | Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| respiratory department Amiens Hospital | Amiens | 80054 | France | |||
| Service de Maladies infectieuses et tropicales |
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Percentage of patients who died between D1 and D28 of the start of treatment
| at day 28 |
| SARS-CoV-2 viral load kinetics | Kinetics of viral load decrease by dosage of the normalized SARS-CoV-2 viral load on nasopharyngeal samples | Day 1, day 7, day 15, day 21 and day 28 |
| proportion of patients who are potential transfer candidates in intensive care | Percentage of patients candidates for transfer to intensive care at Day 15 of the start of treatment | At Day 15 |
| Tolerance of the study treatment | Occurrence of adverse events, severe adverse events and premature discontinuation of study treatment | Within 28 days after treatment initiation |
| Duration of oxygen therapy | Number of days the patient was put on oxygen therapy | Within 28 days after treatment initiation |
| Proportion of patients requiring assisted or non-invasive ventilation | Percentage of patients requiring assisted or non-invasive ventilation | Within 28 days after treatment initiation |
| Duration of assisted or non-invasive ventilation | Number of days the patient was put on assisted or non-invasive ventilation | Within 28 days after treatment initiation |
| Duration of hospitalization in intensive care unit | Number of days spent in intensive care | At day 28. |
| Duration of hospitalization in intensive care unit | Number of days spent in intensive care. For patients still in intensive care on D28 this information will be collected on D90 | At day 90 |
| Hospital length of stay | Number of days spent in hospital | At day 28. |
| Hospital length of stay | Number of days spent in hospital. For patients still in intensive care on D28 this information will be collected on D90 | At day 90 |
| Flow rate of oxygen used | Maximum oxygen rate used | Within 28 days after treatment initiation |
| Extension of viral pneumonitis | Difference in extension of viral pneumonitis on comparative analysis scans performed at D1 and D28 | Day 1, day 28 |
| Amiens |
| 80054 |
| France |
| Département de Pneumologie, CHU Angers | Angers | 49100 | France |
| Service de Pneumologie, CHU Besançon | Besançon | 25030 | France |
| Service de pneumologie Hôpital Haut-Leveque | Bordeaux | 33604 | France |
| Service de Pneumologie CHU Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| Service des Maladies Infectieuses et Tropicales | Fort-de-France | 97261 | France |
| Maladies infectieuses et Tropicales CHU Grenoble Rhône-Alpes | Grenoble | 38043 | France |
| Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon | Lyon | 69004 | France |
| Médecine Interne, Hôpital de la Croix- Rousse, HOSPICES CIVILS DE LYON | Lyon | 69004 | France |
| Clinique des bronches, de l'allergie et du sommeil Hôpital Nord | Marseille | 13015 | France |
| de Pneumologie Groupe Hospitalier du Havre Hôpital | Montivilliers | 76290 | France |
| Pulmonology department CHU Montpellier | Montpellier | 34295 | France |
| Service Pneumologie, Hôpital BICHAT | Paris | 75018 | France |
| Service de Pneumologie, GHU APHP-Sorbonne Université, site Pitié Salpêtrière | Paris | 75651 | France |
| Service de pneumologie, CHLS, Hospices Civils de Lyon | Pierre-Bénite | 69310 | France |
| Médecine interne, CHMS, Hospices Civils de Lyon | Pierre-Bénite | France |
| Department of Pulmonology-Thoracic Oncology, University Hospital of SaintEtienne | Saint-Etienne | 42055 | France |
| Service de pneumologie, CHRU Strasbourg | Strasbourg | 67000 | France |
| Clinique des Voies Respiratoires Hôpital Larrey | Toulouse | 31059 | France |
| Service des Maladies Infectieuses et du Voyageur Hôpital Gustave Dron | Tourcoing | 59208 | France |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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