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

This is an interventional treatment trial for COVID-19 focused on measuring Pneumonia, Viral, Diltiazem Read More

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