Cytokine Release SyndromeNCT04873141
Tocilizumab and Cytokine Release Syndrome (CRS) In Covid-19 Pneumonia
An observational study of Cytokine Release Syndrome and Covid-19 Pneumonia, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Tocilizumab (TCZ), interleukin-6 (IL-6), newly appeared as treatment of cytokine release syndrome (CRS) in patients with severe covid-19 associated pneumonia. In the present study, we aimed to discuss the treatment response of TCZ therapy in COVID-19 infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytokine Release Syndrome, Covid-19 Pneumonia
- What is being tested?
- Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Apr 2020to 22 Jun 2020
- How long will I take part?
- 7 Days
- 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 of age (18-all) and suffering from COVID- 19 severe pneumonia
Who may be able to join
- Age ≥ 18 years old; Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending); Hospitalized with COVID-19-induced pneumonia; Elevated CRP, D-Dimers or ferritin levels; Bodyweight ≥ 40kg.
Who cannot join
- Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; Use of tocilizumab within 3 weeks prior; Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19); Patients with significant neutropenia (ANC <1000/mm3); Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to tocilizumab dose.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, 44000
About this study
Official title: Tocilizumab and Cytokine Release Syndrome (CRS) In Covid-19 Pneumonia: Experience From Single Center of Pakistan
Tocilizumab (TCZ), interleukin-6 (IL-6), newly appeared as treatment of cytokine release syndrome (CRS) in patients with severe covid-19 associated pneumonia. In the present study, we aimed to discuss the treatment response of TCZ therapy in COVID-19 infected patients.
Read the detailed description
This observational study was designed just to visualize the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers.Patients will be followed until Day 29 after randomization.
- Conditions
- Cytokine Release Syndrome, Covid-19 Pneumonia
- Being tested
- Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)
- Keywords
- Cytokine Release Syndrome, Covid-19 Pneumonia, Tocilizumab
- Medical subject headings
- Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)Drug
Also called Actemra
Tocilizumab was given according to weight in patients with cytokinme releasew syndrome (CRS).
| Study group | Role | What they receive |
|---|---|---|
| Case Group | All the patients suffering from severe covid pneumonia and laboratory parameter suggestive of cytokine release syndrome. Receives: Drug: Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
Patient admitted with cytokine release syndrome and given Tocilizumab and primary outcome was death within hospital.
Measured: 28 days
Time to discharge
Time to Hospital Discharge or "Ready for Discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or >/= 2 liters (L) supplemental oxygen.
Measured: 28 days
Secondary outcomes (2)
Laboratory parameters
All the specialized labs (Serum Ferritin, CRP, D- Dimer . IL-6) will be observed till its normal level.
Measured: 30 days
Oxygen Saturation
Patients who were given Tocilizumab, observed for demand of oxygen therapy to see decremental response of oxygen, whether its decreasing or increasing after tocilizumab dosing and it will be observed both in pulse oximeter and oxygen given in L/min.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start28 Apr 2020
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine Release SyndromeStudies 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
- 24 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fibhaa Syed, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Muhammad Hassan, MD, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873141
- Sponsor's protocol ID
- Tocilizumab and CRS
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The study was completed and we retrospectively putting data of a prospective study.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocilizumab and Cytokine Release Syndrome (CRS) In Covid-19 Pneumonia: Experience From Single Center of Pakistan
- ClinicalTrials.gov ID
- NCT04873141
- Acronym / sponsor ID
- Tocilizumab and CRS
- Conditions
- Cytokine Release Syndrome, Covid-19 Pneumonia
- Keywords
- Cytokine Release Syndrome, Covid-19 Pneumonia, Tocilizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 5 May 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.
Tocilizumab (TCZ), interleukin-6 (IL-6), newly appeared as treatment of cytokine release syndrome (CRS) in patients with severe covid-19 associated pneumonia. In the present study, we aimed to discuss the treatment response of TCZ therapy in COVID-19 infected patients.
Detailed description
This observational study was designed just to visualize the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers.Patients will be followed until Day 29 after randomization.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Drug: Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)All the patients suffering from severe covid pneumonia and laboratory parameter suggestive of cytokine release syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of age (18-all) and suffering from COVID- 19 severe pneumonia
Key inclusion criteria (1 listed)
- Age ≥ 18 years old; Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending); Hospitalized with COVID-19-induced pneumonia; Elevated CRP, D-Dimers or ferritin levels; Bodyweight ≥ 40kg.
Key exclusion criteria (1 listed)
- Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; Use of tocilizumab within 3 weeks prior; Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19); Patients with significant neutropenia (ANC <1000/mm3); Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to tocilizumab dose.
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 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)Also: ActemraTocilizumab was given according to weight in patients with cytokinme releasew syndrome (CRS). | Drug | Case Group |
Primary outcome
Mortality Rate
Time frame: 28 days
Patient admitted with cytokine release syndrome and given Tocilizumab and primary outcome was death within hospital.
Time to discharge
Time frame: 28 days
Time to Hospital Discharge or "Ready for Discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or >/= 2 liters (L) supplemental oxygen.
2 secondary outcomes
Laboratory parameters
Time frame: 30 days
Oxygen Saturation
Time frame: 30 days
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 5 May 2021.
- Individual participant dataSharing planned: No. The study was completed and we retrospectively putting data of a prospective study.
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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.
Muhammad Hassan, MD principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
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 Cytokine Release Syndrome and Covid-19 Pneumonia, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
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 1 inclusion and 1 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 5 May 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 Pakistan. 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?
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?
Mortality Rate (time frame: 28 days). 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?
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 5 May 2021.