Pre-emptive tocilizumab in hypoxic COVID-19 patients, a prospective randomized trial

Completed

• Conditions: COVID-19 with Hypoxia

• Registration Number: NL-OMON20031
• Lead Sponsor: MCG, Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 354

Inclusion Criteria

? Patients 18 years and older
? Patients with a diagnosis of COVID-19 based on a compatible clinical presentation AND a positive SARS-CoV-2 PCR on a respiratory sample such as a nasopharyngeal swab, sputum, or BAL fluid
? Clinical features compatible with hyperinflammation:
- Hypoxia, without other explanation for hypoxia than COVID-19 OR
- ferritin >2000 µg/L or doubling of serum ferritin in 20-48 hours
Hypoxia is defined according to ASTCT CRS Consensus grading: grade II. [Lee DW, et al. BBMT 2019;25(4):625-638] Inclusion of patients already requiring oxygen administration prior to COVID-19 should be discussed with the study team.
? Written informed consent.
? Patient is capable of giving informed consent.

Exclusion Criteria

? Pregnancy
? allergy to tocilizumab

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30-day mortality (from randomization)