Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Safety (Safety of the product for each patient once the safety assessment stage has been completed. Yes: once this stage is completed, the patient will not have any type of adverse event (AE), or those who will report are mild, related or not to PrevengHo®-Vir. No: once this stage was completed, the patient reported any AE with moderate or severe intensity, severe or non-severe, related to PrevengHo®-Vir). Measurement time: Close of the sixth week.
Key secondary outcomes:
1. Type of Adverse Event-AE (Clinical manifestations that appear as an unwanted effect; according to symptoms, signs and syndromes). Measurement time: Weekly, during the first six weeks of the study.
2. Severity (Risk of the effect caused by an AE in an individual. Serious: Death of the patient, threat to the life of the subject, requires hospitalization or prolongs an existing hospitalization, produces significant or persistent disability/invalidity. Non-serious: Does not meet any of the above requirements). Measurement time: Weekly, during the first six weeks of the study.
3. Intensity (Graduation in which an AE can be presented. Mild: It is well tolerated, causes minimal discomfort and does not interfere with daily activities. Moderate: Annoying enough to prevent or interfere with daily activities. Severe: Prevents daily activities). Measurement time: Weekly, during the first six weeks of the study.
4. Imputability (Degree of medication-AE association, according to the algorithm of Karch and Lasagna. Definitive: Clinical event that occurs in a plausible temporal relationship with the administration of the drug, which cannot be explained by the disease, another drug, or another chemical, disappears when the drug is withdrawn and reappears with the re-exposure to the drug. Likely: The above conditions are met except that there is no re-exposure or the information is unknown. Possible: Clinical event, with a reasonable time sequence with the administration of the drug, which can also be explained by the disease, another drug or another chemical substance, the information about the suspension of the use of the drug may be absent or not clear. Not related to the clinical event: It has no causal relationship with the product used). Measurement time: Weekly, during the first six weeks of the study.
5. Outcome of the AE in relation to the patient (Final situation that the patient arrives after having the EA. Recovered: The patient resolved the EA and recovered his state of health. Not Recovered: EA is maintained. Recovered with sequela: The EA is resolved but some sequel remains in the patient. Deadly: The patient dies). Measurement time: Weekly, during the first six weeks of the study.
6. Episodes of Acute Respiratory Infection-ARI (If the patient presented any manifestation of ARI symptoms, according to its definition. Yes: Incidence of IRA episodes. No: ARI is not diagnosed). Measurement time: Monthly, up to December 31rst, 2020.
7. Symptoms presented (These are the symptoms of an ARI episode. According to incidence (Yes/No) of symptoms (fever, cough, sore throat, shortness of breath, joint pain/myalgia, others)). Measurement time: Monthly, up to December 31rst, 2020.
8. Intensity of the episodes (Degrees in which the episode of IRA occurs. Mild: Episode well tolerated, causes minimal discomfort and does not interfere with daily activities. Moderate: Episode bothersome enough to impede or interfere with daily activities. Severe: Episode that prevents daily activities and leads to hospital admission). Measurement time: Monthly, up to December 31rst, 2020.
9. Duration of the episode in days (Duration of the IRA episode). Measurement time: Monthly, up to December 31rst, 2020.
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