This is a single-center observational clinical study investigating evaluable prognostic factors among patients with COVID-19 syndrome.
The data of all adult patients who passed through the high and low intensity COVID-19 wards in the period between November 2020 and January 2021 were analyzed.
An important stratification of the population is linked to the type of patient, whether acute or critical, based on the intensity of care and assistance provided. Subsequently, the set of comorbidities presented by single individuals was considered, using the Charlson Comorbidity Index (CCI) as a score.
From a metabolic point of view, the type of nutrition in place was highlighted, the insulin schemes used (in terms of hypoglycemic effects), and the variations in the entry and exit of the main electrolytes (Sodium (Na +) and Potassium (K +).
Finally, the blood gas collection, during non-invasive ventilation or oxygen therapy delivery, further allowed the implementation of prognostic knowledge.
A sample of n.= 100 patients (63 male, 37 female), divided into two homogeneous groups based on the intensity of care (n. = 50 in high-intensity care (HIC), and n. = 50 in low-intensity care (LIC) unit), was analyzed to obtain a significance level of 0.05 and a power of 0.90. The average age of the low-intensity care population is 74.06 ± 16.05 years, the high-intensity patients’ average age is 81 ± 13.21 years. All patients have radiological signs of COVID-19 related pneumonia. Of these 100 patients, 67 are affected by type 2 diabetes mellitus (49 in the HIC group, 18 in the LIC group), 72% under oral hypoglycemic treatment while 28% under insulin therapy. Further pathologies most represented are obesity (60% in the HIC group, 40% in the LIC group), chronic obstructive pneumonia (75% in the HIC, of which 50% under home oxygen therapy, 55% in the LIC group, of which 20% with home oxygen therapy), arterial hypertension (80% in the high-intensity group, of which 40% with a history of ischemic heart disease and 20% with a history of major cerebrovascular events , 60% in the LIC group, of which 30% with a history of ischemic heart disease and 15% with a history of major cerebrovascular events), solid neoplasms (40% in the HIC group, 15% in the LIC group) and haematological (30% in the HIC group, 10% in the LIC one), chronic renal failure with evolution to acute (75% in the HIC group, 55% in the LIC group).
Patients were recruited from StAndrea Hospital (Rome), in "COVID-19 unit". The study has been subjected to review and approval by the Ethics Committee of the same hospital, in accordance with the guidelines of the Ministry of Health and the Declaration of Helsinki with revision of 2000.
All study participants have read and approved the informed consent for the processing of personal data.
Subjects included in the study are over 18 years of age, are able to intend and have tested positive for SARS COV2 infection at the time of enrollment.
In order to understand which is the most correct prognostic evaluation of patients with COVID - 19 syndrome, parameters and timing were analyzed as listed below.
• Date of birth
District and general physical examination
• Physical state
• Head and neck
• Lymph node
• Cardiovascular system
• Respiratory System
• Cardiovascular parameters
• Blood pressure and heart rate
• Fasting blood sugar
• Glycated hemoglobin (for diabetic patients)
• Hematological profile
• Electrolytic profile
• Glycemic profile during the hospital stay (from the first day of hospitalization to the seventh day, not including the first 24 hours of transit in the ward)
• Blood gas analysis profile
Days of hospitalization
DIRECT ACCESS TO THE ORIGINAL DOCUMENTATION
The investigator must allow the National Regulatory Authority, and the staff designated by the Independent Ethics Committee or the coordinating investigator, direct access to the complete original documentation - and its verification - including informed consent, signed by enrolled patients or their Legal Representatives, and medical records or outpatient records. Persons who have direct access to this documentation should take all reasonable precautions to maintain the patient's identity and all information that is owned by the Coordinating Investigator, in accordance with applicable laws.
QUALITY ASSURANCE PROCEDURES
The organization, monitoring and quality assurance of this study will be the responsibility of the coordinating investigator.
Clinical monitoring will be carried out by qualified persons appointed by the Coordinating Investigator and will be conducted according to the guidelines of the ISO 14155-1 Standard. Furthermore, the monitoring activities will include verifying the correct compilation of the CRFs and, where applicable, the consistency between the source documents and the electronic archived data used for the randomization procedures. The coordinating investigator will ensure the practical training of the personnel involved in the study on surgical and medical techniques and on the filling of CRFs.
Data review and audit
Data review and audits will be performed by qualified persons appointed by the coordinating investigator.
There are two analysis populations that will be used in the assessment of treatment differences: intent-to-treat (coinciding with the analysable population for safety) and evaluable efficacy.
The intent-to-treat (ITT) population consists of all patients who received medical treatment. The population evaluable for efficacy consists of all ITT patients who completed the study, i.e. all patients in whom the primary endpoint was measured.
All categorical variables (binary or with more than two modalities) will be analyzed using a Chi-Square test or Fisher Exact test when appropriate. For continuous variables the relative deltas will be calculated as the difference between the 1-year values and the baseline values over the baseline values and will be analyzed by means of a t-test for independent samples. Differences between groups and trends over time will also be analyzed using the Analysis of Variance for Repeated Measurements.
Safety and tolerability analysis
All patients who have undergone surgical treatment will be included in the safety analysis. Safety analyzes will include tabulation of the type and frequency of any adverse events recorded. Between-group differences in the percentage of patients reporting an adverse event will be analyzed using Fisher's exact test, while all ongoing laboratory safety assessments will be summarized using descriptive statistics and related deltas calculated. The deltas will be analyzed by the Mann-Whitney U test or the T test as appropriate.
All parties involved in the study agree and verify that the experimental study is conducted in compliance with the ethical principles deriving from the Helsinky Declaration, the guidelines of Good Clinical Practice (GPC) and applicable laws.
The coordinating investigator is responsible for submitting this clinical protocol to the local Independent Ethics Committee (IEC) for approval prior to enrolling patients. The coordinating investigator will need to provide the IEC with all documents necessary to obtain approval. Such study will be notified or submitted for approval by the Health Authority in accordance with applicable laws.
Prior to the start of the study, the Informed Consent forms to be provided to patients and / or their Legal Representatives must be submitted to the Independent Ethics Committee for review and approval, along with the protocol.