COVID-19 PneumoniaNCT05057962
Tocilizumab in Covid-19 Penumonia in Buenos Aires City
An observational study of COVID-19 Pneumonia and Tocilizumab, run by Sanatorio Finochietto at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Tocilizumab
- How many people
- 100 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2021to 4 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 18 years and older at admission.
- Confirmed diagnosis of severe SARS CoV 2 infection.
- category 6 and 7 of World's Health Organization (WHO) COVID 19 ordinal scale on Clinical Improvement .
Who cannot join
- under 18 years of age no Confirmed diagnosis of SARS CoV 2 infection. category 1dnd 5 of World's Health Organization (WHO) COVID 19 ordinal scale on Clinical Improvement .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tocilizumab for Treatment of SARS Cov2 Pneumonia. Experience in a Private Health Center Facility in Buenos Aires City.
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.
Read the detailed 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 eliminarán 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
- Conditions
- COVID-19 Pneumonia, Tocilizumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
death during hospitalization
Measured: From the date of admission to the date of death from any cause or discharge from hospital, whichever occurs first
Secondary infections
infection demonstrated with cultures of blood, urine, or respiratory specimens during hospitalization
Measured: From the date of admission to the date of death from any cause or discharge from hospital, whichever occurs first
WHO COVID 19 ordinal scale on Clinical Improvement and the 14 days
difference in the who ordinal scale between the date of worsening and the 14 days of the same, with 1 being the best value and 8 the worst (death)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Jul 2021
- Primary completion7 Sep 2021
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanatorio Finochietto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazareno Galvalisi, Sanatorio Finochietto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057962
- Sponsor's protocol ID
- 5489
- Status last verified
- May 2022
- First submitted
- 8 Sep 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocilizumab for Treatment of SARS Cov2 Pneumonia. Experience in a Private Health Center Facility in Buenos Aires City.
- ClinicalTrials.gov ID
- NCT05057962
- Acronym / sponsor ID
- 5489
- Conditions
- COVID-19 Pneumonia, Tocilizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sanatorio FinochiettoUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 eliminarán 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 18 years and older at admission.
- Confirmed diagnosis of severe SARS CoV 2 infection.
- category 6 and 7 of World's Health Organization (WHO) COVID 19 ordinal scale on Clinical Improvement .
Key exclusion criteria (1 listed)
- under 18 years of age no Confirmed diagnosis of SARS CoV 2 infection. category 1dnd 5 of World's Health Organization (WHO) COVID 19 ordinal scale on Clinical Improvement .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: From the date of admission to the date of death from any cause or discharge from hospital, whichever occurs first
death during hospitalization
Secondary infections
Time frame: From the date of admission to the date of death from any cause or discharge from hospital, whichever occurs first
infection demonstrated with cultures of blood, urine, or respiratory specimens during hospitalization
WHO COVID 19 ordinal scale on Clinical Improvement and the 14 days
Time frame: 14 days
difference in the who ordinal scale between the date of worsening and the 14 days of the same, with 1 being the best value and 8 the worst (death)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Tocilizumab, run by Sanatorio Finochietto at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: From the date of admission to the date of death from any cause or discharge from hospital, whichever occurs first). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.