Covid19Phase 3COVIDSTORMNCT04577534
COVID-19: Salvage TOcilizumab as a Rescue Measure
A Phase 3 study testing iv Tocillizumab (TCZ) in people with Covid19, run by Jarmo Oksi at 1 site in Finland.
Trial summary
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- iv Tocillizumab (TCZ)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFinland
- Study dates
- 14 Aug 2020to 16 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consaent obtained
- hospitalized with COVID-19 disease
- Age >/= 18 years
- SARS CoV-2 NhO posit
- Sp=2 </93% on ambient air or respiratory rate >30 /min
- Any 2 of the 4: P-IL-6 > 2 x ULN / P-ferritin > 2 x ULN / P-FIDD >1.5 mg/l / P- CRP >40 mg/l without obvious presence of bacterial infection (normal values: P -IL-6 <5.9 ng/l; P-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l ; P-FIDD (Fibrin degradation products, D-dimer) <0.5 mg/l; P-CRP <10 mg/l)
Who cannot join
- Known severe allergic reactions to monoclonal antibodies
- Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides COVID-19)
- In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day)
- Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by laboratory test (U-hCG-O).
- Participating in other drug clinical trials
Show all 9Show fewer
- Absolute neutrophil count < 1 x10E9/l
- Platelet count <50 x10E9/l
- ALAT >10x ULN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
- Conditions
- Covid19
- Being tested
- iv Tocillizumab (TCZ)
- Keywords
- COVID-19, new coronavirus disease, tocilizumab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iv Tocillizumab (TCZ)Drug
Participants are randomized (2:1) to receive TCZ or Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab (TCZ) | Experimental | Participants will receive one infusion of iv TCZ (according to weight of patient) Receives: Drug: iv Tocillizumab (TCZ) |
| standard of care (no TCZ) | No intervention | Participants will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status at day 28
(assessed using 7-category ordinal scale) 7 death 6 in ICU with ECMO/ mechanical ventilation 5 in ICU, no ECMO/ mechanical ventilation 4 in hospital, not ICU, needs supplementary oxygen 3 in hospital, not ICU, no supplementary oxygen 2 not in hospital, but not back to normal
1 not in hospital, back to normal
Measured: day 28
Secondary outcomes (15)
Time to clinical improvement
defined as a National Early Warning Score 2 (NEWS2) of>/=2 maintained for 24 hours
Measured: 28 days
Time to decline of at least 2 categories
relative on a 7-category ordinalscale of clinical status
Measured: 28 days
Incidence of mechanical and/or non-invasive ventilation
(mode and duration of respiratory support) Hospital day when respiratory support needed with non-invasive ventilation - and duration.
Hospital day when respiratory support needed by invasive mechanical ventilation -and duration.
Measured: 28 days
Number of ventilator-free days to day 28
days not in ventilator
Measured: 28 days
Organ failure free days to day 28
days without organ failure
Measured: 28 days
Incidence of ICU stay
ICU admission day
Measured: 28 days
Duration of ICU stay
days on ICU
Measured: 28 days
Time to clinical failure
time to death, mechanical ventilation, or ICU admission (whichever occurs first)
Measured: 28 days
SAPS II
during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst)
Measured: 28 days
CCI
during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)
Measured: 28 days
APACHE II
during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst)
Measured: 28 days
SOFA 6
during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst)
Measured: 28 days
Mortality rate
during and end of period of 28 days
Measured: 28 days
Time to hospital discharge or "ready for discharge"
as evidenced by normal body temperature and respiratory rate and stable oxygen saturation on ambient air or </=2 l supplemental oxygen
Measured: 28 days
Duration of supplemental oxygen
days on suppl oxygen
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start14 Aug 2020
- Primary completion16 Jun 2021
- Study completion16 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jarmo Oksi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jarmo Oksi, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577534
- Sponsor's protocol ID
- EudraCT 2020-002039-31
- Other IDs
- 2020-002039-31, T124/2020, KLnro 36/2020, dnro 68/06.00.01/2020
- Acronym
- COVIDSTORM
- Status last verified
- Jun 2021
- First submitted
- 3 Sep 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: plan to investigate if it is possible by law
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease
- ClinicalTrials.gov ID
- NCT04577534
- Acronym / sponsor ID
- COVIDSTORM / EudraCT 2020-002039-31
- Conditions
- Covid19
- Keywords
- COVID-19, new coronavirus disease, tocilizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Jarmo OksiOther government
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab (TCZ) | Experimental | Drug: iv Tocillizumab (TCZ)Participants will receive one infusion of iv TCZ (according to weight of patient) |
| standard of care (no TCZ) | No intervention | –Participants will receive standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- written informed consaent obtained
- hospitalized with COVID-19 disease
- Age >/= 18 years
- SARS CoV-2 NhO posit
- Sp=2 </93% on ambient air or respiratory rate >30 /min
Key exclusion criteria (9 listed)
- Known severe allergic reactions to monoclonal antibodies
- Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides COVID-19)
- In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day)
- Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by laboratory test (U-hCG-O).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iv Tocillizumab (TCZ)Participants are randomized (2:1) to receive TCZ or Standard of Care | Drug | Tocilizumab (TCZ) |
Primary outcome
Clinical status at day 28
Time frame: day 28
(assessed using 7-category ordinal scale) 7 death 6 in ICU with ECMO/ mechanical ventilation 5 in ICU, no ECMO/ mechanical ventilation 4 in hospital, not ICU, needs supplementary oxygen 3 in hospital, not ICU, no supplementary oxygen 2 not in hospital, but not back to normal 1 not in hospital, back to normal
15 secondary outcomes
Time to clinical improvement
Time frame: 28 days
Time to decline of at least 2 categories
Time frame: 28 days
Incidence of mechanical and/or non-invasive ventilation
Time frame: 28 days
Number of ventilator-free days to day 28
Time frame: 28 days
Organ failure free days to day 28
Time frame: 28 days
Incidence of ICU stay
Time frame: 28 days
Duration of ICU stay
Time frame: 28 days
Time to clinical failure
Time frame: 28 days
SAPS II
Time frame: 28 days
CCI
Time frame: 28 days
APACHE II
Time frame: 28 days
SOFA 6
Time frame: 28 days
Mortality rate
Time frame: 28 days
Time to hospital discharge or "ready for discharge"
Time frame: 28 days
Duration of supplemental oxygen
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided. plan to investigate if it is possible by law
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iv Tocillizumab (TCZ) in people with Covid19, run by Jarmo Oksi at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical status at day 28 (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.