Covid19Phase 2COVITOZ-01NCT04435717
Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)
A Phase 2 study testing Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 and Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) in people with Covid19, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 and Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 4 May 2020to 10 Feb 2021
- Phase
- Phase 2
- 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
- Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
- The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:
- to. Basal oxygen saturation> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315
- The patient is hospitalized or meets hospital admission criteria.
- The patient is not expected to enter the ICU or die in the next 24 hours.
Who cannot join
- Participants in another simultaneous clinical trial.
- Use of other immunomodulators.
- Coinfection with the hepatitis B virus (detectable AgSup-HBV).
- Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
- Presence of laboratory abnormalities of grade ≥ 4.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
Read the detailed description
National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved.
The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia.
78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.
- Conditions
- Covid19
- Being tested
- Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1, Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1Drug
Tocilizumab 20 MG/ML Intravenous (one dose)
Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)Drug
Also called Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1
Tocilizumab 20 MG/ML Intravenous ( two doses)
| Study group | Role | What they receive |
|---|---|---|
| TCZ 8 mg / kg one dose | Experimental | TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment Receives: Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 |
| TCZ 8 mg / kg in two | Experimental | TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment Receives: Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) |
| standard care treatment | No intervention | Usual / standard care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
Average increase in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
Measured: Day1 and Day3.
Secondary outcomes (19)
Progression of pneumonia
Percentage of patients per group with progression of pneumonia in Day3, Day 7 and Day28
Measured: Day3, Day7 and Day28
PaO2/FiO2
Proportion of patients with PaO2 / FiO2 <300 (or SatO2 / FiO2 ≤315) at some point in the evolution.
Measured: Day3, Day7 and Day28
cause mortality to 28 days after started treatment
cause mortality to 28 days after started treatment
Measured: Day3, Day7 and Day28
Length of hospital stay
Length of hospital stay
Measured: Day3, Day7 and Day28
patients requiring Intensive Care Unit admission
Percentage of patients requiring Intensive Care Unit admission
Measured: Day3, Day7 and Day28
evolution of inflammatory parameters IL12
IL-12 levels at Day 7
Measured: Day0, Day3 and Day7
evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma
IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels on days Day 0, Day1, Day 3 and Day 7
Measured: Day0, Day3 and Day7
evolution of inflammatory parameters Procalcitonin (PCT),
Procalcitonin (PCT), levels on days Day0, Day1, Day3 and Day 7
- 7
Measured: Day0, Day3 and Day7
evolution of inflammatory parameters C-reactive protein (PCR),
C-reactive protein (PCR),levels on days Day0, Day1, Day3 and Day 7
- 7
Measured: Day0, Day3 and Day7
evolution of inflammatory parameters D-dimer
D-dimer levels on days Day0, Day1, Day3 and Day 7
- 7
Measured: Day0, Day3 and Day7
evolution of inflammatory parameters and ferritin
ferritin levels on days Day0, Day1, Day3 and Day 7
- 7
Measured: Day0, Day3 and Day7
pharmacokinetics of tocilizumab Cmin
Cmin,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
Measured: Day0, Day1 Day3 and Day7
pharmacokinetics of tocilizumab Cmax
Cmax,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
Measured: days Day0, Day1 Day3 and Day7
pharmacokinetics of tocilizumab Cmedia
Cmedia,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
Measured: days Day0, Day1 Day3 and Day7
pharmacokinetics of tocilizumab Tmax
Tmax,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
Measured: days Day0, Day1 Day3 and Day7
pharmacokinetics of tocilizumab AUC
AUC,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
Measured: days Day0, Day1 Day3 and Day7
Adverse event
Serious and non-serious adverse events.
Measured: days Day0, Day3, Day7 and Day28
Adverse event to cause the treatment interruption.
Adverse events to cause the treatment interruption.
Measured: days Day0, Day3, Day7 and Day28
Adverse event Abnormalities in laboratory
Abnormalities in laboratory findings unrelated to COVID-19 disease.
Measured: days Day0, Day3, Day7 and Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start4 May 2020
- Primary completion4 Nov 2020
- Study completion10 Feb 2021
Why it stopped: Futility
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients eligible to be included in the study will be randomized in a 1: 1: 1 ratio to receive: * TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment * TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment * Usual / standard care treatment
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose A Perez Molina, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435717
- Sponsor's protocol ID
- COVITOZ-01
- Acronym
- COVITOZ-01
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04435717
- Acronym / sponsor ID
- COVITOZ-01 / COVITOZ-01
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 17 Jun 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.
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
Detailed description
National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved.
The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia.
78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients eligible to be included in the study will be randomized in a 1: 1: 1 ratio to receive: * TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment * TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment * Usual / standard care treatment
| Arm | Type | Receives |
|---|---|---|
| TCZ 8 mg / kg one dose | Experimental | Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment |
| TCZ 8 mg / kg in two | Experimental | Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment |
| standard care treatment | No intervention | –Usual / standard care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
- The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:
- to. Basal oxygen saturation> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315
- The patient is hospitalized or meets hospital admission criteria.
- The patient is not expected to enter the ICU or die in the next 24 hours.
Key exclusion criteria (5 listed)
- Participants in another simultaneous clinical trial.
- Use of other immunomodulators.
- Coinfection with the hepatitis B virus (detectable AgSup-HBV).
- Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
- Presence of laboratory abnormalities of grade ≥ 4.
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 |
|---|---|---|
| Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1Tocilizumab 20 MG/ML Intravenous (one dose) | Drug | TCZ 8 mg / kg one dose |
| Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)Also: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1Tocilizumab 20 MG/ML Intravenous ( two doses) | Drug | TCZ 8 mg / kg in two |
Primary outcome
Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
Time frame: Day1 and Day3.
Average increase in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
19 secondary outcomes
Progression of pneumonia
Time frame: Day3, Day7 and Day28
PaO2/FiO2
Time frame: Day3, Day7 and Day28
cause mortality to 28 days after started treatment
Time frame: Day3, Day7 and Day28
Length of hospital stay
Time frame: Day3, Day7 and Day28
patients requiring Intensive Care Unit admission
Time frame: Day3, Day7 and Day28
evolution of inflammatory parameters IL12
Time frame: Day0, Day3 and Day7
evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma
Time frame: Day0, Day3 and Day7
evolution of inflammatory parameters Procalcitonin (PCT),
Time frame: Day0, Day3 and Day7
evolution of inflammatory parameters C-reactive protein (PCR),
Time frame: Day0, Day3 and Day7
evolution of inflammatory parameters D-dimer
Time frame: Day0, Day3 and Day7
evolution of inflammatory parameters and ferritin
Time frame: Day0, Day3 and Day7
pharmacokinetics of tocilizumab Cmin
Time frame: Day0, Day1 Day3 and Day7
pharmacokinetics of tocilizumab Cmax
Time frame: days Day0, Day1 Day3 and Day7
pharmacokinetics of tocilizumab Cmedia
Time frame: days Day0, Day1 Day3 and Day7
pharmacokinetics of tocilizumab Tmax
Time frame: days Day0, Day1 Day3 and Day7
pharmacokinetics of tocilizumab AUC
Time frame: days Day0, Day1 Day3 and Day7
Adverse event
Time frame: days Day0, Day3, Day7 and Day28
Adverse event to cause the treatment interruption.
Time frame: days Day0, Day3, Day7 and Day28
Adverse event Abnormalities in laboratory
Time frame: days Day0, Day3, Day7 and Day28
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No
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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 2 study testing Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 and Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) in people with Covid19, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Aug 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Futility). Results are not available in the source record.
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?
Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3. (time frame: Day1 and Day3.). 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 30 Aug 2021.