SARS PneumoniaPhase 2NCT04315480
Tocilizumab for SARS-CoV2 (COVID-19) Severe Pneumonitis
A Phase 2 study testing Tocilizumab in people with SARS Pneumonia, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
In a Phase 2 Simon's Optimal Two-Stages Design intravenous tocilizumab will be administered as single 8mg/Kg dose in patients affected by severe multifocal interstitial pneumonia correlated to SARS-CoV2 infection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- SARS Pneumonia
- 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
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 12 Mar 2020to May 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SARS-CoV2 Infection diagnosed by rt-PCR
- CT-scan confirmed multifocal interstitial pneumonia
- Need of oxygen therapy to maintain SO2>93%
- Worsening of lung involvement, defined as (one of the following criteria):
- Worsening of oxygen saturation >3 percentage points or decrease in PaO2 >10%, with stable FiO2 in the last 24h
- Need of increase FiO2 in order to maintain a stable SO2 or new onset need of mechanical ventilation in the last 24h
- Increase in number and/or extension of pulmonary areas of consolidation
Who cannot join
- Age <18 ys and >90 ys
- Severe heart failure
- Bacterial Infection
- Haematological neoplasm
- Neutrophil count below 1000/mcl
- Platelet count below 50000/mcl
- ALT> x5UNL
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tocilizumab (RoActemra) as Early Treatment of Patients Affected by SARS-CoV2 (COVID-19) Infection With Severe Multifocal Interstitial Pneumonia
In a Phase 2 Simon's Optimal Two-Stages Design intravenous tocilizumab will be administered as single 8mg/Kg dose in patients affected by severe multifocal interstitial pneumonia correlated to SARS-CoV2 infection. Aim of the study is to test the hypothesis that an anti-IL6 treatment can be effective in calming the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing naso-tracheal intubation and/or death.
- Conditions
- SARS Pneumonia
- Being tested
- Tocilizumab
- Keywords
- Tocilizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
single intravenous administration 8mg/Kg
| Study group | Role | What they receive |
|---|---|---|
| tocilizumab | Experimental | Not described Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
arrest in deterioration of pulmonary function
rate of patients with no need in increase of FiO2 to maintain stable SO2 and no need of intubation
Measured: 7days
improving in pulmonary function
rate of patients with change of oxygen saturation >3 percentage points or >10% or decrease in FiO2 need or reduction in pulmonary consolidations >30% at HR CT-scan
Measured: 7 days
Secondary outcomes (2)
need of oro-tracheal intubation
rate of patients needed of intubation
Measured: +7 days
death
rate of patients dead
Measured: 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start12 Mar 2020
- Primary completion9 Apr 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SARS 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simon's Two-stages Optimal Design
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Responsible party
- Principal investigator, Armando Gabrielli, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315480
- Sponsor's protocol ID
- TOCICOV-1
- Status last verified
- Apr 2020
- First submitted
- 14 Mar 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tian S, Hu W, Niu L, Liu H, Xu H, Xiao SY. Pulmonary Pathology of Early-Phase 2019 Novel Coronavirus (COVID-19) Pneumonia in Two Patients With Lung Cancer. J Thorac Oncol. 2020 May;15(5):700-704. doi: 10.1016/j.jtho.2020.02.010. Epub 2020 Feb 28.
PubMed 32114094Ashour HM, Elkhatib WF, Rahman MM, Elshabrawy HA. Insights into the Recent 2019 Novel Coronavirus (SARS-CoV-2) in Light of Past Human Coronavirus Outbreaks. Pathogens. 2020 Mar 4;9(3):186. doi: 10.3390/pathogens9030186.
PubMed 32143502Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
PubMed 28466096Zumla A, Ippolito G, Ntoumi F, Seyfert-Margolies V, Nagu TJ, Cirillo D, Chakaya JM, Marais B, Maeurer M. Host-directed therapies and holistic care for tuberculosis. Lancet Respir Med. 2020 Apr;8(4):337-340. doi: 10.1016/S2213-2600(20)30078-3. Epub 2020 Feb 27. No abstract available.
PubMed 32113574Sabbatinelli J, Giuliani A, Matacchione G, Latini S, Laprovitera N, Pomponio G, Ferrarini A, Svegliati Baroni S, Pavani M, Moretti M, Gabrielli A, Procopio AD, Ferracin M, Bonafe M, Olivieri F. Decreased serum levels of the inflammaging marker miR-146a are associated with clinical non-response to tocilizumab in COVID-19 patients. Mech Ageing Dev. 2021 Jan;193:111413. doi: 10.1016/j.mad.2020.111413. Epub 2020 Dec 8.
PubMed 33307107
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocilizumab (RoActemra) as Early Treatment of Patients Affected by SARS-CoV2 (COVID-19) Infection With Severe Multifocal Interstitial Pneumonia
- ClinicalTrials.gov ID
- NCT04315480
- Acronym / sponsor ID
- TOCICOV-1
- Conditions
- SARS Pneumonia
- Keywords
- Tocilizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 9 Apr 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 19 Mar 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.
In a Phase 2 Simon's Optimal Two-Stages Design intravenous tocilizumab will be administered as single 8mg/Kg dose in patients affected by severe multifocal interstitial pneumonia correlated to SARS-CoV2 infection. Aim of the study is to test the hypothesis that an anti-IL6 treatment can be effective in calming the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing naso-tracheal intubation and/or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's Two-stages Optimal Design
| Arm | Type | Receives |
|---|---|---|
| tocilizumab | Experimental | Drug: Tocilizumab |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- SARS-CoV2 Infection diagnosed by rt-PCR
- CT-scan confirmed multifocal interstitial pneumonia
- Need of oxygen therapy to maintain SO2>93%
- Worsening of lung involvement, defined as (one of the following criteria):
Key exclusion criteria (8 listed)
- Age <18 ys and >90 ys
- Severe heart failure
- Bacterial Infection
- Haematological neoplasm
- Neutrophil count below 1000/mcl
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 |
|---|---|---|
| Tocilizumabsingle intravenous administration 8mg/Kg | Drug | tocilizumab |
Primary outcome
arrest in deterioration of pulmonary function
Time frame: 7days
rate of patients with no need in increase of FiO2 to maintain stable SO2 and no need of intubation
improving in pulmonary function
Time frame: 7 days
rate of patients with change of oxygen saturation >3 percentage points or >10% or decrease in FiO2 need or reduction in pulmonary consolidations >30% at HR CT-scan
2 secondary outcomes
need of oro-tracheal intubation
Time frame: +7 days
death
Time frame: 14days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Background: PubMed 32114094Tian S, Hu W, Niu L, Liu H, Xu H, Xiao SY. Pulmonary Pathology of Early-Phase 2019 Novel Coronavirus (COVID-19) Pneumonia in Two Patients With Lung Cancer. J Thorac Oncol. 2020 May;15(5):700-704. doi: 10.1016/j.jtho.2020.02.010. Epub 2020 Feb 28.
- Background: PubMed 32143502Ashour HM, Elkhatib WF, Rahman MM, Elshabrawy HA. Insights into the Recent 2019 Novel Coronavirus (SARS-CoV-2) in Light of Past Human Coronavirus Outbreaks. Pathogens. 2020 Mar 4;9(3):186. doi: 10.3390/pathogens9030186.
- Background: PubMed 28466096Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
- Background: PubMed 32113574Zumla A, Ippolito G, Ntoumi F, Seyfert-Margolies V, Nagu TJ, Cirillo D, Chakaya JM, Marais B, Maeurer M. Host-directed therapies and holistic care for tuberculosis. Lancet Respir Med. 2020 Apr;8(4):337-340. doi: 10.1016/S2213-2600(20)30078-3. Epub 2020 Feb 27. No abstract available.
- Derived from this study: PubMed 33307107Sabbatinelli J, Giuliani A, Matacchione G, Latini S, Laprovitera N, Pomponio G, Ferrarini A, Svegliati Baroni S, Pavani M, Moretti M, Gabrielli A, Procopio AD, Ferracin M, Bonafe M, Olivieri F. Decreased serum levels of the inflammaging marker miR-146a are associated with clinical non-response to tocilizumab in COVID-19 patients. Mech Ageing Dev. 2021 Jan;193:111413. doi: 10.1016/j.mad.2020.111413. Epub 2020 Dec 8.
- 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 in people with SARS Pneumonia, run by Università Politecnica delle Marche at 1 site in Italy.
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 7 inclusion and 8 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 13 Apr 2020. 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 Italy. 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?
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?
arrest in deterioration of pulmonary function (time frame: 7days). The study lists 2 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 NCT04315480, which also lists 5 linked publications.
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 13 Apr 2020.