Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia

NCT ID: NCT05563168

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standard Of Care (SOC) + diltiazem

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.

Group Type: EXPERIMENTAL

DILTIAZEM TEVA 60 mg or placebo

Intervention Type: 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.

SOC + placebo

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

Group Type: PLACEBO_COMPARATOR

DILTIAZEM TEVA 60 mg or placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Signia Therapeutics

UNKNOWN

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Devouassoux, Pr

Role: PRINCIPAL_INVESTIGATOR

Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon

Locations

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 Pneumologie, Hôpital BICHAT

Paris, , France

Service de Pneumologie, GHU APHP-Sorbonne Université, site Pitié Salpêtrière

Paris, , France

Service de pneumologie, CHLS, Hospices Civils de Lyon

Pierre-Bénite, , France

Médecine interne, CHMS, Hospices Civils de Lyon

Pierre-Bénite, , France

Department of Pulmonology-Thoracic Oncology, University Hospital of SaintEtienne

Saint-Etienne, , 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, , France

Countries

France

Other Identifiers

2021-004160-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

69HCL21_0855

Identifier Type: -

Identifier Source: org_study_id