COVID-19UHID-COVID19NCT04359667
Serum IL-6 and Soluble IL-6 Receptor in Severe COVID-19 Pneumonia Treated With Tocilizumab
An observational study of COVID-19 and Severe Pneumonia, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
Trial summary
This is a single arm, prospective, observational, single center study to assess the role of interleukin-6 (IL-6) and soluble interleukin 6 receptor (sIL-6R) as predictors of efficacy and safety outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Severe Pneumonia
- What is being tested?
- Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 16 Jun 2020to 15 May 2021
- Phase
- Observational
- 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
Study population: Patients ≥18 yrs with severe COVID-19 pneumonia (and/or ARDS) confirmed per WHO criteria, and evidence of pulmonary infiltration (by chest X-ray and/or CT scan), including a virological confirmation of SARS-CoV-2 infection by PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid. At enrollment, patients have to fulfill criteria of local recommendations for tocilizumab treatment: hypoxemia regardless of the oxygenation method including low-flow oxygen administration on nasal cannula or mask with oxygen flow rate of > 12 liters per minute, high-flow oxygen through nasal cannula, noninvasive ventilation whatever the modalities of ventilation, invasive ventilation through tracheal intubation or tracheostomy, and extracorporeal oxygenation, despite being on SOC, which may include anti-viral treatment, low dose steroids, antimalarials and supportive treatment and care.
Who may be able to join
- Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
- Age ≥18years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Hospitalized due to severe COVID-19 pneumonia (and/or ARDS) confirmed per World Health Organization criteria, and evidence of pulmonary infiltration (by chest X-ray and/or CT scan), including a virological confirmation of SARS-CoV-2 infection by positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid
- Hypoxemia (defined as a PaO2/FiO2 ratio ≤300 mmHg and/or SpO2≤93%) regardless of their oxygenation device (including low-flow oxygen administration on nasal cannula or mask with oxygen flow rate of > 12 liters per minute), high-flow oxygen through nasal cannula, noninvasive ventilation (NIV) whatever the modalities of ventilation, invasive ventilation through tracheal intubation or tracheostomy, and extracorporeal oxygenation, despite being on SOC, which may include anti-viral treatment, low dose steroids, and supportive care
Who cannot join
- Known severe allergic reactions to TCZ or other monoclonal antibodies
- Active TB infection
- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 6 months
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >10 times the upper limit of the normality detected within 24 hours at screening or at baseline
Show all 10Show fewer
- absolute neutrophil count (ANC) <1000/µL at screening and baseline
- Platelet count <50,000/µL at screening and baseline
- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in the study
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
Zagreb, 10000
Rok Civljak, MD, PhD, ++385914012547, rcivljak@bfm.hr
Arijana Pavelic, BA, ++385914012584, apavelic@bfm.hr
About this study
Official title: Prognostic Value of Serum Interleukin-6 (IL-6) and Soluble Interleukin-6 Receptor (sIL-6R) in Severe Coronavirus Disease (COVID-19) Pneumonia Treated With Tocilizumab - a Prospective Single Center Study (UHID-COVID19)
This is a single arm, prospective, observational, single center study to assess the role of interleukin-6 (IL-6) and soluble interleukin 6 receptor (sIL-6R) as predictors of efficacy and safety outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab. At least 30 patients will be enrolled who are diagnosed with severe COVID-19 pneumonia and meet the entry criteria.
Read the detailed description
Patients must be at least 18 years of age with severe COVID-19 pneumonia (and/or ARDS) confirmed per World Health Organization (WHO) criteria, and evidence of pulmonary infiltration (by chest X-ray and/or CT scan), including a virological confirmation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by positive polymerase chain reaction (PCR) of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid.
At the time of enrollment, patients have to fulfill criteria of the local recommendations for the treatment with tocilizumab (TCZ): hypoxemia (defined as arterial oxygen partial pressure/fraction of inspired oxygen (PaO2/FiO2) ratio ≤300 mmHg and/or peripheral capillary oxygen saturation (SpO2) ≤93%) regardless of the oxygenation method including low-flow oxygen administration on nasal cannula or mask with oxygen flow rate of > 12 liters per minute, high-flow oxygen through nasal cannula, noninvasive ventilation (NIV) whatever the modalities of ventilation, invasive ventilation through tracheal intubation or tracheostomy, and extracorporeal oxygenation, despite being on standard of care (SOC), which may include anti-viral treatment, low dose steroids, antimalarials and supportive treatment and care.
Patients in whom, in the opinion of the treating physician, progression to death is imminent and inevitable within the next 24 hours, will be excluded from the study. Patients with active tuberculosis (TB) or suspected active bacterial, fungal, viral, or other infection (besides COVID-19) will be excluded from the study.
Patients will receive one infusion of TCZ 8 mg/kg i.v., with a maximum dose of 800 mg, and SOC treatment according to local guidelines (hydroxychloroquine or/and lopinavir/ritonavir or/and remdesivir).
If the clinical signs or symptoms worsen or do not improve (reflected by sustained fever or at least a one-category worsening on the 7-category ordinal scale of clinical status), one additional infusion of blinded treatment of TCZ or placebo may be given, after more than 12 hours per local protocol.
The study assessments to be conducted include the following: physical examination, vital signs, oxygen saturation, assessment of consciousness, presence and absence of respiratory support, adverse events, concomitant therapies, clinical laboratory tests, and nasopharyngeal swabs.
- Conditions
- COVID-19, Severe Pneumonia
- Being tested
- Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]
- Keywords
- COVID-19, severe pneumonia, Interleukin-6, tocilizumab
- Medical subject headings
- COVID-19, Pneumonia
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]Drug
Also called RoActemra, Anatomical Therapeutic Chemical (ATC) Code L04AC07
1 - 8 mg per kg of body weight once, maximal 800 mg per dose (can be repeated once more after 12 hours, per clinician's assessment)
| Study group | Role | What they receive |
|---|---|---|
| tocilizumab | one infusion of TCZ 8 mg/kg i.v., with a maximum dose of 800 mg, and SOC treatment according to local guidelines (hydroxychloroquine or/and lopinavir/ritonavir or/and remdesivir). Receives: Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
Measured: baseline
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
Measured: 24 hours post treatment
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
Measured: 48 hours post treatment
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
Measured: on Day 7
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
Measured: on Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start16 Jun 2020
- Primary completion16 Apr 2021 (estimated)
- Study completion15 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital for Infectious Diseases, Croatia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rok Civljak, MD, PhD, Principal investigator, University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359667
- Sponsor's protocol ID
- UHID-04
- Acronym
- UHID-COVID19
- Status last verified
- Jun 2020
- First submitted
- 16 Apr 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Serum Interleukin-6 (IL-6) and Soluble Interleukin-6 Receptor (sIL-6R) in Severe Coronavirus Disease (COVID-19) Pneumonia Treated With Tocilizumab - a Prospective Single Center Study (UHID-COVID19)
- ClinicalTrials.gov ID
- NCT04359667
- Acronym / sponsor ID
- UHID-COVID19 / UHID-04
- Conditions
- COVID-19, Severe Pneumonia
- Keywords
- COVID-19, severe pneumonia, Interleukin-6, tocilizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital for Infectious Diseases, CroatiaUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 16 Apr 2021 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 24 Apr 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.
This is a single arm, prospective, observational, single center study to assess the role of interleukin-6 (IL-6) and soluble interleukin 6 receptor (sIL-6R) as predictors of efficacy and safety outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab. At least 30 patients will be enrolled who are diagnosed with severe COVID-19 pneumonia and meet the entry criteria.
Detailed description
Patients must be at least 18 years of age with severe COVID-19 pneumonia (and/or ARDS) confirmed per World Health Organization (WHO) criteria, and evidence of pulmonary infiltration (by chest X-ray and/or CT scan), including a virological confirmation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by positive polymerase chain reaction (PCR) of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid.
At the time of enrollment, patients have to fulfill criteria of the local recommendations for the treatment with tocilizumab (TCZ): hypoxemia (defined as arterial oxygen partial pressure/fraction of inspired oxygen (PaO2/FiO2) ratio ≤300 mmHg and/or peripheral capillary oxygen saturation (SpO2) ≤93%) regardless of the oxygenation method including low-flow oxygen administration on nasal cannula or mask with oxygen flow rate of > 12 liters per minute, high-flow oxygen through nasal cannula, noninvasive ventilation (NIV) whatever the modalities of ventilation, invasive ventilation through tracheal intubation or tracheostomy, and extracorporeal oxygenation, despite being on standard of care (SOC), which may include anti-viral treatment, low dose steroids, antimalarials and supportive treatment and care.
Patients in whom, in the opinion of the treating physician, progression to death is imminent and inevitable within the next 24 hours, will be excluded from the study. Patients with active tuberculosis (TB) or suspected active bacterial, fungal, viral, or other infection (besides COVID-19) will be excluded from the study.
Patients will receive one infusion of TCZ 8 mg/kg i.v., with a maximum dose of 800 mg, and SOC treatment according to local guidelines (hydroxychloroquine or/and lopinavir/ritonavir or/and remdesivir).
If the clinical signs or symptoms worsen or do not improve (reflected by sustained fever or at least a one-category worsening on the 7-category ordinal scale of clinical status), one additional infusion of blinded treatment of TCZ or placebo may be given, after more than 12 hours per local protocol.
The study assessments to be conducted include the following: physical examination, vital signs, oxygen saturation, assessment of consciousness, presence and absence of respiratory support, adverse events, concomitant therapies, clinical laboratory tests, and nasopharyngeal swabs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tocilizumab | – | Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]one infusion of TCZ 8 mg/kg i.v., with a maximum dose of 800 mg, and SOC treatment according to local guidelines (hydroxychloroquine or/and lopinavir/ritonavir or/and remdesivir). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 yrs with severe COVID-19 pneumonia (and/or ARDS) confirmed per WHO criteria, and evidence of pulmonary infiltration (by chest X-ray and/or CT scan), including a virological confirmation of SARS-CoV-2 infection by PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid. At enrollment, patients have to fulfill criteria of local recommendations for tocilizumab treatment: hypoxemia regardless of the oxygenation method including low-flow oxygen administration on nasal cannula or mask with oxygen flow rate of > 12 liters per minute, high-flow oxygen through nasal cannula, noninvasive ventilation whatever the modalities of ventilation, invasive ventilation through tracheal intubation or tracheostomy, and extracorporeal oxygenation, despite being on SOC, which may include anti-viral treatment, low dose steroids, antimalarials and supportive treatment and care.
Key inclusion criteria (5 listed)
- Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
- Age ≥18years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Hospitalized due to severe COVID-19 pneumonia (and/or ARDS) confirmed per World Health Organization criteria, and evidence of pulmonary infiltration (by chest X-ray and/or CT scan), including a virological confirmation of SARS-CoV-2 infection by positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid
- Hypoxemia (defined as a PaO2/FiO2 ratio ≤300 mmHg and/or SpO2≤93%) regardless of their oxygenation device (including low-flow oxygen administration on nasal cannula or mask with oxygen flow rate of > 12 liters per minute), high-flow oxygen through nasal cannula, noninvasive ventilation (NIV) whatever the modalities of ventilation, invasive ventilation through tracheal intubation or tracheostomy, and extracorporeal oxygenation, despite being on SOC, which may include anti-viral treatment, low dose steroids, and supportive care
Key exclusion criteria (10 listed)
- Known severe allergic reactions to TCZ or other monoclonal antibodies
- Active TB infection
- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 6 months
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]Also: RoActemra, Anatomical Therapeutic Chemical (ATC) Code L04AC071 - 8 mg per kg of body weight once, maximal 800 mg per dose (can be repeated once more after 12 hours, per clinician's assessment) | Drug | tocilizumab |
Primary outcome
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
Time frame: baseline
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
Time frame: 24 hours post treatment
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
Time frame: 48 hours post treatment
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
Time frame: on Day 7
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab
Time frame: on Day 28
to evaluate the role of laboratory markers as predictors of survival in severe COVID-19 pneumonia patients treated with tocilizumab
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Rok Civljak, MD, PhD principal investigator
University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Severe Pneumonia, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
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 10 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 Nov 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 Croatia. 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.
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?
Contact Rok Civljak, MD, PhD (++385914012547, rcivljak@bfm.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab (time frame: baseline). The study lists 5 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 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.