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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05563168
Other study ID # 69HCL21_0855
Secondary ID 2021-004160-94
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date April 2023
Est. completion date December 2024

Study information

Verified date May 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female aged 18 or over - SARS-CoV-2 infection proven by RT-PCR on a nasopharyngeal sample within 72 hours prior to inclusion in the study - Onset of symptoms of viral infection = 7 days - Hospitalization required due to hypoxemia (air saturation < 94% at rest) - Presence of radiological pneumopathy (chest X-ray or non-enhanced thoracic CT) - Patient affiliated to a social security scheme. - Patient capable of giving free, informed and written consent. - Patient with a history of SARS-CoV-2 infection may participate in the study, but this infection must not have occurred within the 3 months prior to his current hospitalization. - Patient who has been vaccinated against SARS-CoV-2 can participate in the study (regardless of the number of doses) - Patient not eligible for specific anti-COVID treatment authorized in France (MA or early access) and not part of the standard of care at the time of the study - Female patient of childbearing age using effective contraception during study participation, the same applies to partners of childbearing age of male patients. Male patients must use condoms. 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 - Hypersensitivity to diltiazem or to any of the excipients - Unaided sinus dysfunction - Unaided 2nd and 3rd degree atrioventricular blocks - Left ventricular failure with pulmonary stasis (cardiogenic edema) - Severe bradycardia (= 40 beats per minute) - In combination with: dantrolene infusion, pimozide, dihydroergotamine, ergotamine, nifedipine, ivabradine, beta blockers, antiarrhythmics, esmolol, fingolimod. - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DILTIAZEM TEVA 60 mg or placebo
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.

Locations

Country Name City State
France respiratory department Amiens Hospital Amiens
France Service de Maladies infectieuses et tropicales Amiens
France Département de Pneumologie, CHU Angers Angers
France Service de Pneumologie, CHU Besançon Besançon
France Service de pneumologie Hôpital Haut-Leveque Bordeaux
France Service de Pneumologie CHU Gabriel Montpied Clermont-Ferrand
France Service des Maladies Infectieuses et Tropicales Fort-de-France
France Maladies infectieuses et Tropicales CHU Grenoble Rhône-Alpes Grenoble
France Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon Lyon
France Médecine Interne, Hôpital de la Croix- Rousse, HOSPICES CIVILS DE LYON Lyon
France Clinique des bronches, de l'allergie et du sommeil Hôpital Nord Marseille
France de Pneumologie Groupe Hospitalier du Havre Hôpital Montivilliers
France Pulmonology department CHU Montpellier Montpellier
France Service de Pneumologie, GHU APHP-Sorbonne Université, site Pitié Salpêtrière Paris
France Service Pneumologie, Hôpital BICHAT Paris
France Médecine interne, CHMS, Hospices Civils de Lyon Pierre-Bénite
France Service de pneumologie, CHLS, Hospices Civils de Lyon Pierre-Bénite
France Department of Pulmonology-Thoracic Oncology, University Hospital of SaintEtienne Saint-Étienne
France Service de pneumologie, CHRU Strasbourg Strasbourg
France Clinique des Voies Respiratoires Hôpital Larrey Toulouse
France Service des Maladies Infectieuses et du Voyageur Hôpital Gustave Dron Tourcoing

Sponsors (2)

Lead Sponsor Collaborator
Hospices Civils de Lyon Signia Therapeutics

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Secondary 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
Secondary Overall survival Percentage of patients who died between D1 and D28 of the start of treatment at day 28
Secondary 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
Secondary 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
Secondary Tolerance of the study treatment Occurrence of adverse events, severe adverse events and premature discontinuation of study treatment Within 28 days after treatment initiation
Secondary Duration of oxygen therapy Number of days the patient was put on oxygen therapy Within 28 days after treatment initiation
Secondary Proportion of patients requiring assisted or non-invasive ventilation Percentage of patients requiring assisted or non-invasive ventilation Within 28 days after treatment initiation
Secondary 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
Secondary Duration of hospitalization in intensive care unit Number of days spent in intensive care At day 28.
Secondary 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
Secondary Hospital length of stay Number of days spent in hospital At day 28.
Secondary 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
Secondary Flow rate of oxygen used Maximum oxygen rate used Within 28 days after treatment initiation
Secondary Extension of viral pneumonitis Difference in extension of viral pneumonitis on comparative analysis scans performed at D1 and D28 Day 1, day 28
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