Tocilizumab in Covid-19 Penumonia in Buenos Aires City

NCT05057962 | Completed DMC

• 1 other identifier: 5489
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Pneumonia; Tocilizumab

Outcome Measures

Primary Outcomes (3)

• Death

  death during hospitalization

  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

  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)

  14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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 .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Sanatorio Finochietto: lead

Study Sites (1)

Nazareno Galvalisi

Buenos Aires, 1187, Argentina

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 27, 2021
• Study Start: July 1, 2021
• Primary Completion: September 7, 2021
• Study Completion: May 4, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

AR (1)