Use of Tocilizumab in the inflammatory phase of COVID-19 / new coronavirus disease

COVIDSTORM - study protocol COVID-19: Slavage TOcilizumab as a Rescue Measure - COVIDSTORM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002039-31-FI

Enrollment

Registered

2020-04-28

Start date

2020-06-17

Completion date

Unknown

Last updated

2021-06-21

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

Conditions

COVID-19 / new coronavirus disease MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862

Interventions

Trade Name: RoActemra Product Name: RoActemra Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age > 18 years / hospitalized with COVID-19 / SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: allergy to monoclonals / active tbc or obvious bact infection / long-term anti-rejection or immunomodul drugs / pregnant or lactating woman / participating in other drug clinical trials

Design outcomes

Primary

Measure	Time frame
Main Objective: avoid / shorten ICU admission;Secondary Objective: shorten ICU stay / clinical improvement / time to hospital discharge;Primary end point(s): clinical status at day 28;Timepoint(s) of evaluation of this end point: day 28	—

Secondary

Measure	Time frame
Secondary end point(s): time to improvement / number of ventilator.free days to d28 / organ failures free days to d28 / incidence of ICU stay / duration of ICU stsy / mortality rate at days 7,14,21,28 /time to h ospital discharge /duration of suppl oxygen;Timepoint(s) of evaluation of this end point: day 28	—

Countries

Finland

Outcome results

None listed

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