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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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.
respiratory department Amiens Hospital
Amiens, France
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.
Time frame: At day 1 and day 7 post treatment initiation.
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
Time frame: Within 28 days post-randomization
Overall survival
Percentage of patients who died between D1 and D28 of the start of treatment
Time frame: 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
Time frame: 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
Time frame: At Day 15
Tolerance of the study treatment
Occurrence of adverse events, severe adverse events and premature discontinuation of study treatment
Time frame: Within 28 days after treatment initiation
Duration of oxygen therapy
Number of days the patient was put on oxygen therapy
Time frame: Within 28 days after treatment initiation
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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
...and 11 more locations
Proportion of patients requiring assisted or non-invasive ventilation
Percentage of patients requiring assisted or non-invasive ventilation
Time frame: 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
Time frame: Within 28 days after treatment initiation
Duration of hospitalization in intensive care unit
Number of days spent in intensive care
Time frame: 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
Time frame: At day 90
Hospital length of stay
Number of days spent in hospital
Time frame: 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
Time frame: At day 90
Flow rate of oxygen used
Maximum oxygen rate used
Time frame: 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
Time frame: Day 1, day 28