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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20031

Enrollment

354

Registered

2020-04-03

Start date

2020-04-06

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 with Hypoxia

Interventions

Patients in this study are treated with intravenous tociluzumab: 8 mg/kg (maximum dose 800 mg), which can be repeated at the same dose after 8 hours if the hypoxia has not improved. This is the approv

Eligibility

Inclusion criteria

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

Exclusion criteria: ? Pregnancy ? allergy to tocilizumab

Design outcomes

Primary

Measure	Time frame
30-day mortality (from randomization)	—

Secondary

Measure	Time frame
- To asses in a randomized comparison days in hospital (calculated from randomisation). - To asses in a randomized comparison the percentage of patients who need ICU care. - To asses in a randomized comparison the percentage of patients who develop respiratory failure and need mechanical ventilation. - To asses in a randomized comparison the days on a ventilator. - To asses in a randomized comparison normalisation of HRCT after resolution of disease. - To asses in a randomized comparison seroconversion 14 days after randomisation - To identify potential biomarkers predictive of response (blood: cytokines (including Il-6 and IL-18), lymphopenia, CRP, ferritin, LDH, sCD25; nasal epithelial brushes: epithelial transcriptome immune response by bulk and single-cell RNA seq; faeces: microbiome, viral load), gender, age, co-morbidity and plasma levels tocilizumab by exploratory analysis. - To assess safety and feasibility of pre-emptive use of tocilizumab (AE grade =4). - To assess in a randomized comparison OS after 3 months (after randomization).	—

Measure

Time frame

- To asses in a randomized comparison days in hospital (calculated from randomisation). - To asses in a randomized comparison the percentage of patients who need ICU care. - To asses in a randomized comparison the percentage of patients who develop respiratory failure and need mechanical ventilation. - To asses in a randomized comparison the days on a ventilator. - To asses in a randomized comparison normalisation of HRCT after resolution of disease. - To asses in a randomized comparison seroconversion 14 days after randomisation - To identify potential biomarkers predictive of response (blood: cytokines (including Il-6 and IL-18), lymphopenia, CRP, ferritin, LDH, sCD25; nasal epithelial brushes: epithelial transcriptome immune response by bulk and single-cell RNA seq; faeces: microbiome, viral load), gender, age, co-morbidity and plasma levels tocilizumab by exploratory analysis. - To assess safety and feasibility of pre-emptive use of tocilizumab (AE grade =4). - To assess in a randomized comparison OS after 3 months (after randomization).

—

Contacts

Public ContactMargriet Dijkstra

UMCG

m.j.dijkstra-tiekstra@umcg.nl+31 50 3610468

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)