Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT05563168
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05563168
Study Brief:
Protocol Section:
NCT05563168