COVID-19Phase 2NCT04445272
Clinical Trial to Evaluate the Effectiveness and Safety of Tocilizumab for Treating Patients With COVID-19 Pneumonia
A Phase 2 study testing Tocilizumab in people with COVID-19, run by Fundacion SEIMC-GESIDA at 42 sites in Spain.
Trial summary
At present, no treatment has been approved for COVID-19. However, in light of the increased interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected patients due to its potential benefit, the Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 42 sitesSpain
- Study dates
- 22 May 2020to 23 Dec 2020
- 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
- Provide oral informed consent to participate in this study.
- At least 18 years of age.
- Diagnosed with COVID-19 pneumonia by RT-PCR.
- Have received the first dose of tocilizumab a maximum of two days before the inclusion or is candidate for tocilizumab treatment
- Hospitalized or admitted to ICU
Who cannot join
- The patient has any other medical condition or is receiving concomitant medication that could, in the opinion of the investigator, compromise the patient's safety or collected data
- Known severe allergic reactions to tocilizumab or other monoclonal antibodies
- Active acute and severe infections, including tuberculosis infection
- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Spain42 sites
Complejo Hospitalario Universitario de Albacete
Albacete
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid
Hospital Infanta Cristina
Badajoz
Hospital Clínic i Provincial Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario de Burgos
Burgos
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid
Hospital Universitario de Galdakao
Galdakao, Bizkaia
Hospital Universitario de Getafe
Getafe, Madrid
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias
Hospital Universitario Dr. Josep Trueta
Girona
Hospital Universitario Clínico San Cecilio
Granada
Hospital Universitario Virgen de las Nieves
Granada
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario Fundación Jiménez Díaz
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Regional Universitario de Málaga
Málaga
Hospital Sant Joan de Déu de Manresa
Manresa, Barcelona
Hospital de Mataró
Mataró, Barcelona
Hospital Rey Juan Carlos
Móstoles, Madrid
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Complexo Hospitalario Universitario de Ourense
Ourense
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands
Complejo Hospitalario de Navarra
Pamplona, Navarre
Hospital Universitario Salamanca
Salamanca
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid
Hospital Universitario Marqués Valdecilla
Santander, Cantabria
Hospital Universitario Virgen de la Macarena
Seville
Hospital Universitario Virgen del Rocío
Seville
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo
Hospital Virgen de la Salud
Toledo
Hospital Público General del Tomelloso
Tomelloso, Ciudad Real
Hospital Clinico Universitario de Valencia
Valencia
Hospital Universitari i Poliectenic La Fe
Valencia
Hospital Universitario Dr. Peset
Valencia
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Hospital Universitario Miguel Servet
Zaragoza
About this study
Official title: A Multicentre, Open-label Clinical Trial to Evaluate the Effectiveness and Safety of Intravenous Tocilizumab for Treating Patients With COVID-19 Pneumonia: the BREATH-19 Study
At present, no treatment has been approved for COVID-19. However, in light of the increased interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected patients due to its potential benefit, the Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) have initiated the controlled distribution of the drug. Tocilizumab is indeed proposed as a potential treatment for severe COVID-19 in Spain. Based on the positive results of tocilizumab in the treatment of COVID-19 patients and the experience of tocilizumab in inducing rapid reversal of CSS in other pathologies several clinical trials and observational studies are being conducted to assess the effectiveness and safety of tocilizumab in COVID-19 patients. Further studies with a large sample size are required to confirm the effectiveness of tocilizumab in patients with COVID-19 pneumonia.
The need for the management of severe COVID-19 disease is imperative, and every effort should be made to collect relevant clinical outcomes. The aim of the present study is to evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia who are currently hospitalized or admitted to ICU by describing improvement of respiratory function and mortality rate. This large real-world cohort therefore provides a unique opportunity to study this potential medicine during the current emergency situation, and support the findings from other ongoing clinical trials and observational studies, such as the Roche-sponsored Phase III study that is planned to start early April.
Read the detailed description
Cytokine storm syndrome (CSS) is caused by the excessive release of cytokines during an exaggerated immune response. CSS can be triggered by infections or therapeutic interventions, being more severe depending on the degree and duration of immune activation. CSS is as a significant on-target side-effect of chimeric antigen receptor (CAR) T-cell therapies, which have been subject to assessment for the treatment of haematological malignancies. Tocilizumab (intravenous, IV) is indicated for the treatment of chimeric antigen receptor CAR T cell-induced severe or life-threatening CSS.
Based on the experience with tocilizumab in the CSS, and that some patients infected with SARS-CoV-2 can develop CSS, leading to potentially fatal damage to lung tissue, the drug is being investigated in China and Italy, and clinical trials are being conducted/planned in these and several other countries. Real-word experience with tocilizumab IV have shown that in a substantial proportion of COVID-19 patients with severe pneumonia, fever returned to normal and respiratory function based on oxygen intake and lung opacities improved remarkably. Laboratory parameters such as C-reactive protein (CRP) that seem to be increased in patients infected decreased significantly with tocilizumab, and lymphocytes levels also returned to normal.
All these findings have led the Spanish Agency for Medicine and Health Products (AEMPS) to initiate the controlled distribution of tocilizumab IV, in light of the increased interest on the anti-cytokine therapy targeting IL-6 in COVID-19 infected patients. Therefore, tocilizumab might be among the therapeutic armamentarium for preventing the fatal consequences of acute respiratory and multi organ failure in around 20% of the COVID-19 infected patients.
The aim of the present study is to evaluate the effectiveness and safety of IV tocilizumab in patients with COVID-19 severe pneumonia who are currently hospitalized or admitted to ICU. This large real-world cohort provides a unique opportunity to study a potential medicine during the current emergency situation, and support the findings from the Roche-sponsored Phase III study that is planned to start in early April.
- Conditions
- COVID-19
- Being tested
- Tocilizumab
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Treatment with Tocilizumab
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Patients will receive IV tocilizumab as per clinical practice and at the discretion of treating investigator, following the posology indicated in the SmPC, or the recommendations proposed by the Spanish Ministry of Health:
The recommended posology by the SmPC is 8 mg per kg in patients weighing greater than or equal to 30 kg or 12 mg per kg in patients weighing less than 30 kg. If no clinical improvement in the signs and symptoms up to 3 additional doses of tocilizumab may be administered. The interval between consecutive doses should be at least 8 hours.
The recommendations of the Spanish Ministry of Health:
Patients more than 80 kg: first dose 600 mg; second dose 600 mg. Patients less than 80 kg: first dose 600 mg; second dose 400 mg.
A third dose might be considered 16 to 24 hours after if: fever persists or a worsening of the laboratory parameters
Given the exceptionality of the situation modification of doses according to the physician experience will be allowed. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To calulate the time of intubation
Calculate the mean time of intubation
Measured: through study completion, and average of 1 month
To calculate the time with oxygen therapy
Calculate the mean time with oxygen therapy
Measured: through study completion, and average of 1 month
To calculate the time with Non-invasive mechanical ventilation
Calculate the mean time with Non-invasive mechanical ventilation
Measured: through study completion, and average of 1 month
To evaluate mortality rate
Number of patients deaths of the total of patients included
Measured: through study completion, and average of 1 month
Secondary outcomes (27)
To calculate respiratory function parameters
To calculate the mean ofPaO2/FiO2
Measured: through study completion, and average of 1 month
To calculate respiratory function parameters
To calculate the mean of levels of oxygen saturation
Measured: through study completion, and average of 1 month
To calculate respiratory function parameters
To calculate the mean of SaO2/FiO2
Measured: through study completion, and average of 1 month
To evaluate radiological lung extension
Evaluate the lung extension of pneumonia
Measured: through study completion, and average of 1 month
To evaluate radiological evolution
Evaluate the type of lung affection
Measured: through study completion, and average of 1 month
To describe the duration of hospitalization and ICU use
Days of hospitalization in survivors and/or days at ICU throughout the study
Measured: through study completion, and average of 1 month
To evaluate the requirement of additional organ support
Percentage of patients with extracorporeal membrane oxygenation
Measured: through study completion, and average of 1 month
To evaluate the requirement of additional organ support
Percentage of patients with molecular adsorbent recirculating system
Measured: through study completion, and average of 1 month
To evaluate the requirement of additional organ support
Percentage of patients with dialysis
Measured: through study completion, and average of 1 month
To evaluate the requirement of additional organ support
Percentage of patients with other support therapy
Measured: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory markers
Analyze the levels of IL-6
Measured: through study completion, and average of 1 month
To calculate the number of adverse events in patients with COVID-19 pneumonia treated with Tocilizumab
Incidence of adverse events
Measured: through study completion, and average of 1 month
To calculate the number of adverse events in patients with COVID-19 pneumonia treated with Tocilizumab
Incidence of adverse events by dose of Tocilizumab
Measured: through study completion, and average of 1 month
To assess time to reverse-transcriptase polymerase chain reaction (RT-PCR) virus negativity
To evaluate the time to RT-PCR virus negativity
Measured: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory
Analyze the levels of CRP
Measured: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory
Analyze the levels of procalcitonin (PCT)
Measured: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory
Analyze the levels of ID-dimer
Measured: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory
Analyze the levels of ferritin
Measured: through study completion, and average of 1 month
To calculate the number of serious adverse events in patients with COVID-19 pneumonia treated with Tocilizumab
Indicende of serious adverse events
Measured: through study completion, and average of 1 month
To calculate the number of serious adverse events in patients with COVID-19 pneumonia treated with Tocilizumab
Indicende of serious adverse events based on dose of Tocilizumab
Measured: through study completion, and average of 1 month
To calculate the number of adverse events of special interest in patients with COVID-19 pneumonia treated with Tocilizumab
Indicende of adverse events of special interest based on dose of Tocilizumab
Measured: through study completion, and average of 1 month
To evaluate mortality rate
Number of patients deaths of the total of patients included based on dose of Tocilizumab
Measured: through study completion, and average of 1 month
To evaluate respiratory function
Time with intubation, oxygen therapy and Non-invasive mechanical ventilation based on dose of Tocilizumab
Measured: through study completion, and average of 1 month
To evaluate mortality rate
Number of patients deaths of the total of patients included based on severity of disease at the start of the study treatment
Measured: through study completion, and average of 1 month
To evaluate mortality rate
Number of patients deaths of the total of patients included based on presence of cytokine storm syndrome at the start of treatment
Measured: through study completion, and average of 1 month
To evaluate respiratory function
Time with intubation, oxygen therapy and Non-invasive mechanical ventilation based on severity of disease at the start of the study treatment
Measured: through study completion, and average of 1 month
To evaluate respiratory function
Time with intubation, oxygen therapy and Non-invasive mechanical ventilation based on presence of cytokine storm syndrome at the start of treatment
Measured: through study completion, and average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start22 May 2020
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II, one-arm, open label, multicentre study
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Dynamic Science S.L.
- Responsible party
- Sponsor
- Investigators
- Jose Antonio Pérez Molina, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445272
- Sponsor's protocol ID
- BREATH-19 (FSG011-20)
- Status last verified
- Jun 2020
- First submitted
- 13 Jun 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maude SL, Barrett D, Teachey DT, Grupp SA. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 2014 Mar-Apr;20(2):119-22. doi: 10.1097/PPO.0000000000000035.
PubMed 24667956
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label Clinical Trial to Evaluate the Effectiveness and Safety of Intravenous Tocilizumab for Treating Patients With COVID-19 Pneumonia: the BREATH-19 Study
- ClinicalTrials.gov ID
- NCT04445272
- Acronym / sponsor ID
- BREATH-19 (FSG011-20)
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Dynamic Science S.L.
- Study start
- 22 May 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 24 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.
At present, no treatment has been approved for COVID-19. However, in light of the increased interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected patients due to its potential benefit, the Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) have initiated the controlled distribution of the drug. Tocilizumab is indeed proposed as a potential treatment for severe COVID-19 in Spain. Based on the positive results of tocilizumab in the treatment of COVID-19 patients and the experience of tocilizumab in inducing rapid reversal of CSS in other pathologies several clinical trials and observational studies are being conducted to assess the effectiveness and safety of tocilizumab in COVID-19 patients. Further studies with a large sample size are required to confirm the effectiveness of tocilizumab in patients with COVID-19 pneumonia.
The need for the management of severe COVID-19 disease is imperative, and every effort should be made to collect relevant clinical outcomes. The aim of the present study is to evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia who are currently hospitalized or admitted to ICU by describing improvement of respiratory function and mortality rate. This large real-world cohort therefore provides a unique opportunity to study this potential medicine during the current emergency situation, and support the findings from other ongoing clinical trials and observational studies, such as the Roche-sponsored Phase III study that is planned to start early April.
Detailed description
Cytokine storm syndrome (CSS) is caused by the excessive release of cytokines during an exaggerated immune response. CSS can be triggered by infections or therapeutic interventions, being more severe depending on the degree and duration of immune activation. CSS is as a significant on-target side-effect of chimeric antigen receptor (CAR) T-cell therapies, which have been subject to assessment for the treatment of haematological malignancies. Tocilizumab (intravenous, IV) is indicated for the treatment of chimeric antigen receptor CAR T cell-induced severe or life-threatening CSS.
Based on the experience with tocilizumab in the CSS, and that some patients infected with SARS-CoV-2 can develop CSS, leading to potentially fatal damage to lung tissue, the drug is being investigated in China and Italy, and clinical trials are being conducted/planned in these and several other countries. Real-word experience with tocilizumab IV have shown that in a substantial proportion of COVID-19 patients with severe pneumonia, fever returned to normal and respiratory function based on oxygen intake and lung opacities improved remarkably. Laboratory parameters such as C-reactive protein (CRP) that seem to be increased in patients infected decreased significantly with tocilizumab, and lymphocytes levels also returned to normal.
All these findings have led the Spanish Agency for Medicine and Health Products (AEMPS) to initiate the controlled distribution of tocilizumab IV, in light of the increased interest on the anti-cytokine therapy targeting IL-6 in COVID-19 infected patients. Therefore, tocilizumab might be among the therapeutic armamentarium for preventing the fatal consequences of acute respiratory and multi organ failure in around 20% of the COVID-19 infected patients.
The aim of the present study is to evaluate the effectiveness and safety of IV tocilizumab in patients with COVID-19 severe pneumonia who are currently hospitalized or admitted to ICU. This large real-world cohort provides a unique opportunity to study a potential medicine during the current emergency situation, and support the findings from the Roche-sponsored Phase III study that is planned to start in early April.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II, one-arm, open label, multicentre study
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: TocilizumabPatients will receive IV tocilizumab as per clinical practice and at the discretion of treating investigator, following the posology indicated in the SmPC, or the recommendations proposed by the Spanish Ministry of Health: The recommended posology by the SmPC is 8 mg per kg in patients weighing greater than or equal to 30 kg or 12 mg per kg in patients weighing less than 30 kg. If no clinical improvement in the signs and symptoms up to 3 additional doses of tocilizumab may be administered. The interval between consecutive doses should be at least 8 hours. The recommendations of the Spanish Ministry of Health: Patients more than 80 kg: first dose 600 mg; second dose 600 mg. Patients less than 80 kg: first dose 600 mg; second dose 400 mg. A third dose might be considered 16 to 24 hours after if: fever persists or a worsening of the laboratory parameters Given the exceptionality of the situation modification of doses according to the physician experience will be allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide oral informed consent to participate in this study.
- At least 18 years of age.
- Diagnosed with COVID-19 pneumonia by RT-PCR.
- Have received the first dose of tocilizumab a maximum of two days before the inclusion or is candidate for tocilizumab treatment
- Hospitalized or admitted to ICU
Key exclusion criteria (4 listed)
- The patient has any other medical condition or is receiving concomitant medication that could, in the opinion of the investigator, compromise the patient's safety or collected data
- Known severe allergic reactions to tocilizumab or other monoclonal antibodies
- Active acute and severe infections, including tuberculosis infection
- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
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 |
|---|---|---|
| TocilizumabTreatment with Tocilizumab | Drug | Tocilizumab |
Primary outcome
To calulate the time of intubation
Time frame: through study completion, and average of 1 month
Calculate the mean time of intubation
To calculate the time with oxygen therapy
Time frame: through study completion, and average of 1 month
Calculate the mean time with oxygen therapy
To calculate the time with Non-invasive mechanical ventilation
Time frame: through study completion, and average of 1 month
Calculate the mean time with Non-invasive mechanical ventilation
To evaluate mortality rate
Time frame: through study completion, and average of 1 month
Number of patients deaths of the total of patients included
27 secondary outcomes
To calculate respiratory function parameters
Time frame: through study completion, and average of 1 month
To calculate respiratory function parameters
Time frame: through study completion, and average of 1 month
To calculate respiratory function parameters
Time frame: through study completion, and average of 1 month
To evaluate radiological lung extension
Time frame: through study completion, and average of 1 month
To evaluate radiological evolution
Time frame: through study completion, and average of 1 month
To describe the duration of hospitalization and ICU use
Time frame: through study completion, and average of 1 month
To evaluate the requirement of additional organ support
Time frame: through study completion, and average of 1 month
To evaluate the requirement of additional organ support
Time frame: through study completion, and average of 1 month
To evaluate the requirement of additional organ support
Time frame: through study completion, and average of 1 month
To evaluate the requirement of additional organ support
Time frame: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory markers
Time frame: through study completion, and average of 1 month
To calculate the number of adverse events in patients with COVID-19 pneumonia treated with Tocilizumab
Time frame: through study completion, and average of 1 month
To calculate the number of adverse events in patients with COVID-19 pneumonia treated with Tocilizumab
Time frame: through study completion, and average of 1 month
To assess time to reverse-transcriptase polymerase chain reaction (RT-PCR) virus negativity
Time frame: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory
Time frame: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory
Time frame: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory
Time frame: through study completion, and average of 1 month
To evaluate the effect of IV tocilizumab on the serum levels of inflammatory
Time frame: through study completion, and average of 1 month
To calculate the number of serious adverse events in patients with COVID-19 pneumonia treated with Tocilizumab
Time frame: through study completion, and average of 1 month
To calculate the number of serious adverse events in patients with COVID-19 pneumonia treated with Tocilizumab
Time frame: through study completion, and average of 1 month
To calculate the number of adverse events of special interest in patients with COVID-19 pneumonia treated with Tocilizumab
Time frame: through study completion, and average of 1 month
To evaluate mortality rate
Time frame: through study completion, and average of 1 month
To evaluate respiratory function
Time frame: through study completion, and average of 1 month
To evaluate mortality rate
Time frame: through study completion, and average of 1 month
To evaluate mortality rate
Time frame: through study completion, and average of 1 month
To evaluate respiratory function
Time frame: through study completion, and average of 1 month
To evaluate respiratory function
Time frame: through study completion, and average of 1 month
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 2 Jun 2021.
- Background: PubMed 24667956Maude SL, Barrett D, Teachey DT, Grupp SA. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 2014 Mar-Apr;20(2):119-22. doi: 10.1097/PPO.0000000000000035.
- 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.
Jose Antonio Pérez Molina principal investigator
Hospital Universitario Ramon y Cajal
42 sites 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 in people with COVID-19, run by Fundacion SEIMC-GESIDA at 42 sites 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 4 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 2 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 42 sites 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 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?
To calulate the time of intubation (time frame: through study completion, and average of 1 month). 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?
On the ClinicalTrials.gov record for NCT04445272, which also lists 1 linked publication.
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 2 Jun 2021.