COVID-19 PneumoniaPhase 3NCT05002517
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab
A Phase 3 study testing Tociliziumab group and Methylprednisolone group in people with COVID-19 Pneumonia, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
Trial summary
Randomized, open, single-center, controlled clinical trial, with 2 treatment arms that seeks to demonstrate the effectiveness of tocilizumab against systemic corticosteroids, both treatments added to supportive treatment in patients admitted for COVID-19 with bilateral pneumonia and poor evolution Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Tociliziumab group and Methylprednisolone group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 3 Sep 2020to 31 Oct 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 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Patient over 18 years old
- 2) Ability to grant consent
- 3) Bilateral pneumonia produced by SARS-CoV-2 without response in 48-72 hours after starting the treatment used according to the local protocol. This is defined as persistence of fever (above 37.5ºC without another focus) and respiratory worsening (more dyspnea and / or more cough and / or oxygen therapy at increasing doses and / or worsening of the degree of respiratory distress according to the PaO2 / FiO2 ratio in categories "mild, moderate or severe") or absence of improvement compared to the previous state
- 4) Persistently elevated inflammatory markers, among which the following must be met: ferritin greater than 1000 ng / mL and / or D-dimer greater than 1500 ng / mL and / or IL-6 greater than 40 pg / mL [35-37], and / or CRP above 150 (mg / L) or having doubled the CRP provided it was above 50. Since this is what is included within the definition of "inflammatory phenotype"
Who cannot join
- 1) Embarazo y lactancia
- 2) Situación terminal o esperanza de vida inferior a 30 días a juicio del investigador
- 3) Alergia o intolerancia a alguno de los fármacos en estudio o a alguno de los excipientes de los preparados (p. ej polisorbato 80)
- 4) Interacción no tolerable de los fármacos del estudio con alguna medicación crónica imprescindible del paciente
- 5) Transaminasas elevadas por encima de cinco veces el límite superior de la normalidad
- 6) Severe neutropenia (<500 cells / mm3)
Show all 15Show fewer
- 7) Plaquetopenia <50,000 / mm3
- 8) Sepsis (clinical suspicion of active infection at another level with a value on the qSOFA scale of two or more points) or septic shock (need for vasopressors to maintain a mean arterial pressure greater than or equal to 65 mmHg, with a lactate of more 2 mmol / L, despite adequate volume replacement
- 9) Another active infection at any level
- 10) Complicated diverticulitis or intestinal perforation
- 11) Renal failure with estimated glomerular filtration rate less than 30 mL / min
- 12) Hepatic failure (Child B onwards)
- 13) Previous use (during the acute process or as chronic medication for another reason) of medication with a potential effect in this phase of the disease (janus kinase inhibitors, interleukin 1 inhibitors, other immunosuppressants or immunomodulators that in the opinion of the investigator could have an effect on the disease based on pathophysiological criteria or on previous research or started in this same period). Clarification: The use of dexamethasone according to the RECOVERY study guideline or corticosteroid therapy at equivalent doses will not be included at this point.
- 14) Being included in another clinical trial
- 15) Patients who, due to their current situation, their baseline situation or other aspects, in the opinion of the researcher, are not considered candidates to enter the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinical Research Platform Biodonostia Health Research Institute
San Sebastián, Guipuzcoa, 20014
About this study
Official title: Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab Against Systemic Corticotherapy in Patients Admitted by Covid-19 With Bilateral Pneumonia and Poor Evolution
Randomized, open, single-center, controlled clinical trial, with 2 treatment arms that seeks to demonstrate the effectiveness of tocilizumab against systemic corticosteroids, both treatments added to supportive treatment in patients admitted for COVID-19 with bilateral pneumonia and poor evolution
- Conditions
- COVID-19 Pneumonia
- Being tested
- Tociliziumab group, Methylprednisolone group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tociliziumab groupDrug
Tocilizumab is a humanized recombinant IgG1 monoclonal antibody to human interleukin-6 (IL-6) receptor, produced in Chinese hamster ovary cells by recombinant DNA technology.
Methylprednisolone groupDrug
Methylprednisolone belongs to a group of medicines called corticosteroids (it works at the cellular level by reducing the production of substances that cause inflammation or allergy).
| Study group | Role | What they receive |
|---|---|---|
| Tociliziumab group | Experimental | Patients assigned to this arm will receive an intravenous dose of tocilizumab. Patients weighing 75 kg or more will receive 600 mg. Those weighing less than 75 kg will receive 400 mg. Receives: Drug: Tociliziumab group |
| Metilprednisolone group | Active comparator | Patients in this arm will receive a daily intravenous dose of 250 mg methylprednisolone for 3 days. Receives: Drug: Methylprednisolone group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory situation at 24 hours, 3 and 7 days based on the PaO2 / FiO2 ratio that graduates respiratory distress into mild (200-300), moderate (100-200) and severe (<100).
Quantitative variable that will be analyzed as qualitative (better, worse) based on whether there is a change in the graduation described above.
Measured: 7 days
Immune hyperactivation situation: LDH, D-dimer and ferritin value at 24 hours, 3 and 7 days. Each one is a quantitative variable.
They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 2 of the 3 variables will be considered "worse"; "Better" if there is improvement in 2 of the 3.
Measured: 7 days
Mechanical ventilation: qualitative variable (yes or no)
Measured: 7 days
Combined variable of variables i, iii and in-hospital mortality (this is understood to be: respiratory deterioration or need for mechanical ventilation or in-hospital death)
Measured: 7 days
Secondary outcomes (9)
Number of patients admitted to the ICU
Measured: 10 months
Time to admission to the ICU (from the beginning of the trial and from the beginning of the picture)
Measured: 10 months
Time to the start of mechanical ventilation (from the start of the trial and from the start of the picture)
Measured: 10 months
Time of admission to ICU
Measured: 10 months
Total admission time
Measured: 10 months
In-hospital mortality
Measured: 10 months
Mortality at 30 and 60 days
Measured: 60 days
Respiratory situation at 30 and 60 days according to pulse oximetric O2 saturation, respiratory rate and presence of dyspnea and NYHA grade.
Measured: 10 months
Documented nosocomial infections
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start3 Sep 2020
- Primary completion31 Jul 2021
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002517
- Sponsor's protocol ID
- TOCICOVID
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 12 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 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab Against Systemic Corticotherapy in Patients Admitted by Covid-19 With Bilateral Pneumonia and Poor Evolution
- ClinicalTrials.gov ID
- NCT05002517
- Acronym / sponsor ID
- TOCICOVID
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 12 Aug 2021 (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.
Randomized, open, single-center, controlled clinical trial, with 2 treatment arms that seeks to demonstrate the effectiveness of tocilizumab against systemic corticosteroids, both treatments added to supportive treatment in patients admitted for COVID-19 with bilateral pneumonia and poor evolution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tociliziumab group | Experimental | Drug: Tociliziumab groupPatients assigned to this arm will receive an intravenous dose of tocilizumab. Patients weighing 75 kg or more will receive 600 mg. Those weighing less than 75 kg will receive 400 mg. |
| Metilprednisolone group | Active comparator | Drug: Methylprednisolone groupPatients in this arm will receive a daily intravenous dose of 250 mg methylprednisolone for 3 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) Patient over 18 years old
- 2) Ability to grant consent
- 3) Bilateral pneumonia produced by SARS-CoV-2 without response in 48-72 hours after starting the treatment used according to the local protocol. This is defined as persistence of fever (above 37.5ºC without another focus) and respiratory worsening (more dyspnea and / or more cough and / or oxygen therapy at increasing doses and / or worsening of the degree of respiratory distress according to the PaO2 / FiO2 ratio in categories "mild, moderate or severe") or absence of improvement compared to the previous state
- 4) Persistently elevated inflammatory markers, among which the following must be met: ferritin greater than 1000 ng / mL and / or D-dimer greater than 1500 ng / mL and / or IL-6 greater than 40 pg / mL [35-37], and / or CRP above 150 (mg / L) or having doubled the CRP provided it was above 50. Since this is what is included within the definition of "inflammatory phenotype"
Key exclusion criteria (15 listed)
- 1) Embarazo y lactancia
- 2) Situación terminal o esperanza de vida inferior a 30 días a juicio del investigador
- 3) Alergia o intolerancia a alguno de los fármacos en estudio o a alguno de los excipientes de los preparados (p. ej polisorbato 80)
- 4) Interacción no tolerable de los fármacos del estudio con alguna medicación crónica imprescindible del paciente
- 5) Transaminasas elevadas por encima de cinco veces el límite superior de la normalidad
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 |
|---|---|---|
| Tociliziumab groupTocilizumab is a humanized recombinant IgG1 monoclonal antibody to human interleukin-6 (IL-6) receptor, produced in Chinese hamster ovary cells by recombinant DNA technology. | Drug | Tociliziumab group |
| Methylprednisolone groupMethylprednisolone belongs to a group of medicines called corticosteroids (it works at the cellular level by reducing the production of substances that cause inflammation or allergy). | Drug | Metilprednisolone group |
Primary outcome
Respiratory situation at 24 hours, 3 and 7 days based on the PaO2 / FiO2 ratio that graduates respiratory distress into mild (200-300), moderate (100-200) and severe (<100).
Time frame: 7 days
Quantitative variable that will be analyzed as qualitative (better, worse) based on whether there is a change in the graduation described above.
Immune hyperactivation situation: LDH, D-dimer and ferritin value at 24 hours, 3 and 7 days. Each one is a quantitative variable.
Time frame: 7 days
They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 2 of the 3 variables will be considered "worse"; "Better" if there is improvement in 2 of the 3.
Mechanical ventilation: qualitative variable (yes or no)
Time frame: 7 days
Combined variable of variables i, iii and in-hospital mortality (this is understood to be: respiratory deterioration or need for mechanical ventilation or in-hospital death)
Time frame: 7 days
9 secondary outcomes
Number of patients admitted to the ICU
Time frame: 10 months
Time to admission to the ICU (from the beginning of the trial and from the beginning of the picture)
Time frame: 10 months
Time to the start of mechanical ventilation (from the start of the trial and from the start of the picture)
Time frame: 10 months
Time of admission to ICU
Time frame: 10 months
Total admission time
Time frame: 10 months
In-hospital mortality
Time frame: 10 months
Mortality at 30 and 60 days
Time frame: 60 days
Respiratory situation at 30 and 60 days according to pulse oximetric O2 saturation, respiratory rate and presence of dyspnea and NYHA grade.
Time frame: 10 months
Documented nosocomial infections
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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 3 study testing Tociliziumab group and Methylprednisolone group in people with COVID-19 Pneumonia, run by Biogipuzkoa Health Research Institute 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 12 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 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?
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?
Respiratory situation at 24 hours, 3 and 7 days based on the PaO2 / FiO2 ratio that graduates respiratory distress into mild (200-300), moderate (100-200) and severe (<100). (time frame: 7 days). The study lists 4 primary outcomes in all. 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 12 Aug 2021.