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Clinical Trial Details

Trial ID: L3341
Source ID: NCT04365517
Associated Drug: Sitagliptin
Title: The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients
Acronym: SIDIACO
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Covid19|Diabetes Mellitus, Type 2|CKD
Interventions: DRUG: Sitagliptin
Outcome Measures: Primary: Time for clinical improvement, Evaluation of the time between randomization and two-point improvement on a seven-category scale (1, not hospitalized, return to normal activities; 2, not hospitalized, but unable to return to normal activities; 3, hospitalized without the need for oxygen therapy; 4, hospitalized, need for oxygen therapy; 5, hospitalized, need for non-invasive ventilatory support; 6, hospitalized, need for invasive mechanical ventilation or Extra Corporeal Membrane Oxygenation; 7, death), 1 month|Clinical parameter of acute lung disease, Clinical evaluation of the physiological parameter "cough" associated with acute lung disease from the start of the study to the end of the study., 1 month|Biochemical parameter of acute lung disease, Variation of biochemical parameter "glycemia" of acute lung disease from the beginning of the study to the end of study., 1 month|Clinical parameter of acute lung disease, Variation of the clinical parameter "oxygen saturation by the use of a pulse oximeter" of acute lung disease from the beginning of the study to the end of the study., 1 month|Clinical parameter of acute lung disease, Variation of the clinical parameter "body temperature" of acute lung disease from the beginning of the study to the end of the study., 1 month|Clinical parameter of acute lung disease, Variation of the clinical parameter "respiratory rate" of acute lung disease from the beginning of the study to the end of the study., 1 month|Clinical parameter of acute lung disease, Variation of the clinical parameter "need for ventilatory support" of acute lung disease from the beginning of the study to the end of the study., 1 month|Clinical parameters of acute lung disease, Variation of the clinical parameters "duration in days of ventilatory support, duration in days of oxygen therapy, duration in days of hospitalization, duration in days in the Intensive Care Unit, total length of stay in hospital" of acute lung disease from the beginning of the study to the end of the study., 1 month|Clinical parameter of acute lung disease, Variation of the clinical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of the study., 1 month|Clinical parameter of acute lung disease, Variation of the clinical parameter "chest X ray" of acute lung disease from the beginning of the study to the end of the study., 1 month|Clinical parameter of acute lung disease, Variation of the clinical parameter "PaO2/FiO2 ratio" of acute lung disease from the beginning of the study to the end of the study., 1 month|Biochemical parameter of acute lung disease, Variation of biochemical parameter "reactive C protein" of acute lung disease from the beginning of the study to the end of study., 1 month|Biochemical parameter of acute lung disease, Variation of biochemical parameter "blood count with formula" of acute lung disease from the beginning of the study to the end of study., 1 month|Biochemical parameter of acute lung disease, Variation of biochemical parameter "erythrocyte sedimentation rate" of acute lung disease from the beginning of the study to the end of study., 1 month|Biochemical parameter of acute lung disease, Variation of biochemical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of study., 1 month|Biochemical parameter of acute lung disease, Variation of biochemical parameter "LDH" of acute lung disease from the beginning of the study to the end of study., 1 month | Secondary: Dipeptilpeptidase 4 expression in biological samples, The alteration of Dipeptilpeptidase 4 expression will be evaluated in the collected biological samples, 6 months|Cytokine-inflammatory profile, Evaluation of inflammatory cytokines IL-2 and IL-7 in biological samples of treated patients and control group patients during infection., 6 months|Glycemic variability, Effect on glycemic variability by evaluating HbA1c levels., 1 month|Glycemic variability, Effect on glycemic variability by evaluating the average daily blood glucose levels., 1 month|Cytokine-inflammatory profile, Evaluation of the inflammatory cytokine granulocyte-colony stimulating factor in biological samples of treated patients and control group patients during infection., 6 months|Cytokine-inflammatory profile, Evaluation of the inflammatory cytokine interferon-γ inducible protein 10 in biological samples of treated patients and control group patients during infection., 6 months|Cytokine-inflammatory profile, Evaluation of the inflammatory cytokine monocyte chemoattractant protein 1 in biological samples of treated patients and control group patients during infection., 6 months|Cytokine-inflammatory profile, Evaluation of the inflammatory cytokine macrophage inflammatory protein 1-α in biological samples of treated patients and control group patients during infection., 6 months|Cytokine-inflammatory profile, Evaluation of the inflammatory cytokine tumour necrosis factor-α in biological samples of treated patients and control group patients during infection., 6 months
Sponsor/Collaborators: Sponsor: University of Milan
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 170
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-29
Completion Date: 2022-12-30
Results First Posted:
Last Update Posted: 2021-09-28
Locations: ASST FBF Sacco, Milan, 20157, Italy
URL: https://clinicaltrials.gov/show/NCT04365517