Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05057962 |
Other study ID # |
5489 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2021 |
Est. completion date |
May 4, 2022 |
Study information
Verified date |
May 2022 |
Source |
Sanatorio Finochietto |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
We conducted a retrospective observational study of adult participants receiving only SOC
(dexamethasone 8 mg or its equivalent plus oxygen, HNFO or eventual IMV) versus participants
receiving SOC plus TCZ (8mg/kg as a single dose) as treatment for severe or critical SARS
CoV2 pneumonia. The inclusion date will be the date of admission, and follow up will conclude
at death or discharge (whichever occurs first) to describe clinical and laboratory
characteristics and outcome of adult participants receiving only standard of care (SOC)
versus participants receiving SOC plus TCZ as treatment for severe or critical SARS CoV2
pneumonia.
Description:
Settings Emergency Department, General Ward and Intensive Care Unit (ICU) at Sanatorio
Finochietto in Buenos Aires City, Argentina. Sanatorio Finochietto is a third level health
care facility that provides health care services in prevalent clinical and surgical
pathologies. It has the formerly mentioned units; as well as a Maternity Ward and
complementary services (such as Laboratory, Radiology and Hemodynamics) and a total of 161
beds 30 of which are ICU beds.
Population Adult participants 18 years old and older receiving SOC plus TCZ versus only SOC
as treatment for severe or critical SARS CoV2 pneumonia in Sanatorio Finochietto, between
March 1st and August 31st 2021.
Participants in the control group couldn't receive TCZ because they were out of therapeutic
window or had secondary infections suspicion.
Exposure variable is TCZ yes/no.
Inclusion Criteria
- Participants 18 years and older at admission.
- Confirmed diagnosis of severe SARS CoV 2 infection.
- Participants in category 6 and 7 of World's Health Organization (WHO) COVID 19 ordinal
scale on Clinical Improvement (in Annexa).
Variables of study
Sociodemographics:
Sex. Categoric, dichotomous. M: male. F: female. Age. At time of admission. Numerical,
continual, in years. Weight. At time of admission. Numerical, continual, in kg. Height.
Numerical, continual, in cm. Body Mass Index (BMI). Numerical, continual. It will be
calculated by the formula weight/height2.
Clinical characteristics Medical History. Nominal category. 1: Asthma 2: Chronic Obstructive
Pulmonary Disease (COPD) 3: Diabetes (DBT) 4: High blood pressure (HBP) 5: Obesity 6:
Coronary disease 7: Heart failure 8: Solid Tumor 9: Oncohematologycal diseasse 10: Person
living with Human Immunodeficiency Virus (PLWHIV).
Acute Physiology and Chronic Health Evaluation II (APACHE II). Numerical, continual.
Symptoms onset date. Numerical, continual. Admission date. Numerical, continual. Steroids
onset date. Numerical, continual. Total steroids days. Numerical, continual. Defined as
dexamethasone dose equal or over 8 mg.
Methylprednisolone pulse. Nominal category. Yes/No. Defined as infusion of at least 500 mg
methylprednisolone.
Number of methylprednisolone pulses. Numerical, continual. IMV. Nominal category. Yes/No. IMV
days. Numerical, continual. HNFO. Nominal category. Yes/No. HFNO. Numerical, continual.
Shock. Nominal category. Yes/No. Defined as vasopressor requirements for 24 hours or more.
Other organ failure. Nominal category. Yes/No. Defined as organ failure besides hemodinamic
or respiratory failure.
Worsening date. Numerical, continual. Worsening is defined as more oxygen requirement (non
rebreather mask or high nasal flow oxygen).
TCZ infusion. Nominal category. Yes/no. TCZ infusion date. Numerical, continual. TCZ dose.
Numerical, continual. TCZ adverse reaction. Nominal category. Yes/No. Defined as adverse
reaction during infusion, neutropenia at 24/48 hs and 7th day or discharge (whichever occurs
first) and/or hepatic enzymes elevation above five times normal value at 24/48 hs and 7th day
or discharge (whichever occurs first).
WHO COVID 19 ordinal scale on Clinical Improvement at worsening. Numerical, continual.
WHO COVID 19 ordinal scale on Clinical Improvement at 14th day or discharge (whichever occurs
first). Numerical, continual.
CRP value. Numerical, continual. At tociluzumab's infusion date or closest previous.
Ferritin value. Numerical, continual. At tociluzumab's infusion date or closest previous.
D dimer value. Numerical, continual. At tociluzumab's infusion date or closest previous.
CRP value at discharge. Numerical, continual. At discharge or closest previous. Ferritin
value at discharge. Numerical, continual. At discharge or closest previous.
D dimer value at discharge. Numerical, continual. At dishcarge or closest previous.
Secondary infections. Open Survival. Nominal category. Yes/no. Cause of death. Open.
Discharge date. Numerical, continual.
Data circuit Information will be collected from electronic records. Given that all severe
SARS CoV 2 pneumonia participants with SOC or SOC plus TCZ will be included, sample
calculation won't be estimated.
Statistical analysis In the descriptive analysis, quantitative data are expressed as mean and
standard deviation or median and interquartile range 25-75 (IQR) according to their
distribution. Data normality was evaluated using charts and Kolmogorov-Smirnov's test.
Qualitative data are expressed as absolute and relative frequency in percentage. For
comparison between groups, chi2 or Fisher test were used according to assumptions for
qualitative data and Wilcoxon for quantitative data according to their distribution. A
significance level of less than 0.05 was considered. R software version 4.0.3 was used.
Ethical considerations This investigation will be conducted under national and international
regulatory rules about human health investigations; and according to Ministry Resolutions,
Helsinki declaration and all its amendments and Good Clinical Practice Guidelines ICH E6.
All study data will be processed with the utmost confidentiality and anonymously, with
restricted access only to authorized personnel and for study purposes only according to
current legislation of National Personal Data Protection Laws (Ley de Habeas data) and Law
26529/09.
Data will be encoded using a numerical code randomly generated. This code will replace the
patient's name and last name. Identificatory data in database comprehensed in the 18
identifiers of HIPPA rules will be eliminated (A su vez se eliminarĂ¡n los datos
identificatorios de la base de datos a analizar comprendido por los 18 identificadores
detallados por las normas HIPAA). Database will be saved in a computer and accessed with a
code and only by the principal investigator. After statistical analysis it will be
eliminated.
This is an observational study and uses a secondary database, and constitutes a minimal risk
investigation; so according to CIOMS 2016 and Pauta 10, exception of informed consent for
participants is requested.
Endpoints Secondary infections, death at discharge, WHO COVID 19 ordinal scale on Clinical
Improvement at 14 days from worsening or discharge (whichever occurs first).
Financing Cost in administrative and human resources for the study will be assumed by
principal investigators. There will be no extraordinary costs for subjects nor health care
providers.
Interest conflicts Investigators declares none interest conflicts