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

Phase 2

Completed

• Conditions: Corona; COVID-19; 10047438; 10046304

• Registration Number: NL-OMON49824
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 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 *g/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.
* Not be pregnant
* Written informed consent.
* Patient is capable of giving informed consent.
* No known allergy to tocilizumab.

Exclusion Criteria

Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified