Created at Source Raw Value Validated value
Aug. 5, 2021, 3:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a single-center; randomized; controlled; open-label; pilot study to assess the safety and the performance of Sentinox medical device in the treatment of mild COVID-19 patients. The study will consist of 9 visits. At the screening visit; according to the investigational site procedures; patients with a positive COVID-19 nasopharyngeal swab (quantitative swab test with RT-PCR Ct value =30 for at least 2 genes out of 4) performed at the investigational site on the same day will be summoned. Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. According to the investigator's judgment; the patient\u2019s clinical outcomes; and the investigational site guidelines; the enrolled patients should be hospitalized or redirected to other structures (e.g. \u201cCOVID-19 hotel\u201d; patient\u2019s home). At Visit 0 (day 0); the patient will be randomized with a 1:1:1 ratio in one of 3 trial groups: 1. Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy); 2. Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy); 3. Group C: no Sentinox treatment; only the standard therapy will be performed. The allocation of the patient in one of the three study arms will be performed sequentially by the principal investigator or delegates in the order in which the subjects are enrolled and will be reported in a randomization list; including the identification code of the patient and the treatment arm (A; B or C) assigned. The randomization list; retained in the investigation site; is limited to the", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "3 times/day for 5 days", "treatment_id": 1185, "treatment_name": "Sentinox", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "5 times/day for 5 days", "treatment_id": 1185, "treatment_name": "Sentinox", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

May 20, 2021, 7:59 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a single-center; randomized; controlled; open-label; pilot study to assess the safety and the performance of Sentinox medical device in the treatment of mild COVID-19 patients. The study will consist of 9 visits. At the screening visit; according to the investigational site procedures; patients with a positive COVID-19 nasopharyngeal swab (quantitative swab test with RT-PCR Ct value >30 for at least 2 genes out of 4) performed at the investigational site on the same day will be summoned. Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. According to the investigator's judgment; the patient\u2019s clinical outcomes; and the investigational site guidelines; the enrolled patients should be hospitalized or redirected to other structures (e.g. \u201cCOVID-19 hotel\u201d; patient\u2019s home). At Visit 0 (day 0); the patient will be randomized with a 1:1:1 ratio in one of 3 trial groups: 1. Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy); 2. Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy); 3. Group C: no Sentinox treatment; only the standard therapy will be performed. The allocation of the patient in one of the three study arms will be performed sequentially by the principal investigator or delegates in the order in which the subjects are enrolled and will be reported in a randomization list; including the identification code of the patient and the treatment arm (A; B or C) assigned. The randomization list; retained in the investigation site; is limited to the", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]