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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001375-32-NL

Enrollment

354

Registered

2020-04-03

Start date

2020-04-03

Completion date

Unknown

Last updated

2021-06-28

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

Conditions

Hypoxia

Interventions

Trade Name: Roactemra Product Name: roactemra Pharmaceutical Form: Injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: L04AC07 Other descriptive name: TOCILIZUMAB

Eligibility

Sex/Gender

All

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. ? 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

Exclusion criteria: pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess in a randomized comparison the effect of pre-emptive Tocilizumab in patients with hypoxia due to COVID-19 on 30-day mortality (from randomization);Secondary Objective: To asses in a randomized comparison: - days in hospital (calculated from randomization) - the percentage of patients who need ICU care. - the percentage of patients who develop respiratory failure and need mechanical ventilation - the days on a ventilator. - normalization of HRCT after resolution of disease - seroconversion 14 days after randomization - 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, increase in dyspnea according to CRS scale) - OS after 3 months (after randomization) - quality of life and pulmonary function after 3 months (after randomization);Primary end point(s): ? 30-day mortality (from randomization);Timepoint(s) of evaluation of this end point: 30 days after randomization	—

Measure

Time frame

Main Objective: To assess in a randomized comparison the effect of pre-emptive Tocilizumab in patients with hypoxia due to COVID-19 on 30-day mortality (from randomization);Secondary Objective: To asses in a randomized comparison: - days in hospital (calculated from randomization) - the percentage of patients who need ICU care. - the percentage of patients who develop respiratory failure and need mechanical ventilation - the days on a ventilator. - normalization of HRCT after resolution of disease - seroconversion 14 days after randomization - 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, increase in dyspnea according to CRS scale) - OS after 3 months (after randomization) - quality of life and pulmonary function after 3 months (after randomization);Primary end point(s): ? 30-day mortality (from randomization);Timepoint(s) of evaluation of this end point: 30 days after randomization

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Secondary

Measure	Time frame
Secondary end point(s): • 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). • To asses in a randomized comparison quality of life and pulmonary function after 3 months (after randomization);Timepoint(s) of evaluation of this end point: Up to three months after randomization	—

Measure

Time frame

Secondary end point(s): • 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). • To asses in a randomized comparison quality of life and pulmonary function after 3 months (after randomization);Timepoint(s) of evaluation of this end point: Up to three months after randomization

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Countries

Netherlands

Contacts

Public ContactPrincipal Investigator

UMCG

a.rutgers@umcg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026