Early intervention with Tocilizumab in patients with COVID-19 and hypoxia

Phase 1

• Conditions: Hypoxia; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001375-32-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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.
?Not be pregnant
?Written informed consent.
?Patient is capable of giving informed consent.
?No known allergy to tocilizumab.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 254

Exclusion Criteria

pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified