Serum IL-6 and Soluble IL-6 Receptor in Severe COVID-19 Pneumonia Treated With Tocilizumab

NCT04359667 | Unknown DMC

• 1 other identifier: UHID-04
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. At least 30 patients will be enrolled who are diagnosed with severe COVID-19 pneumonia and meet the entry criteria.

Conditions

COVID-19; Severe Pneumonia

Keywords

COVID-19; severe pneumonia; Interleukin-6; tocilizumab

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  on Day 28

Study Arms (1)

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).

Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]

Interventions

Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA] DRUG

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)

Also known as: RoActemra, Anatomical Therapeutic Chemical (ATC) Code L04AC07

tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital for Infectious Diseases, Croatia: lead

Study Sites (1)

University Hospital for Infectious Diseases "Dr Fran Mihaljevic"

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rok Civljak, MD, PhD

  University Hospital for Infectious Diseases "Dr Fran Mihaljevic"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rok Civljak, MD, PhD

CONTACT

++385914012547; rcivljak@bfm.hr

Arijana Pavelic, BA

CONTACT

++385914012584; apavelic@bfm.hr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 24, 2020
• Study Start: June 16, 2020
• Primary Completion: April 16, 2021
• Study Completion: May 15, 2021
• Last Updated: November 12, 2020

Record last verified: 2020-06

Locations

CR (1)