Covid19Phase 4NCT04730323
TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience
A Phase 4 study testing Tocilizumab in people with Covid19, run by FMH College of Medicine and Dentistry at 1 site in Pakistan.
Trial summary
Investigators conducted this study to see the effectiveness of Tocilizumab in COVID-19 participants who were in cytokine release syndrome and there was also a control group who received steroids(RECOVERY TRIAL wasn't published or available at that time) this study was conducted in the early days of 1st wave of COVID… Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Covid19
- 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
- 93 participants
- Where
- 1 sitePakistan
- Study dates
- 12 May 2020to 12 Jun 2020
- Phase
- Phase 4
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients diagnosed with COVID-19 infection with positive reverse transcriptase RT-PCR test, willing to participate in this study or PCR negative patients with clinically COVID-19 Pneumonia in cytokine storm as evidenced by raised inflammatory markers with typical radiological changes
- Patients of both genders were included
- Patients having an age of > 65 years with proven Cardiomyopathy, Coronary artery disease, chronic lung disease, Immunosuppressed or organ transplant End-stage renal disease on history \& examination and medical records and having any 1 out of 4 Fever 0f
- ≥39 C
- Hypotension or drop in mean arterial pressure of > 10mmHg
- Progressive Hypoxemia requiring > 5 liters of oxygen
Show all 19Show fewer
- Sustained Respiratory rate >30/min with any 2 laboratory parameters out of 3 are present D-dimers ≥ 1000 ng/ml C-reactive protein CRP ≥ 100mg/L Ferritin ≥ 600ng/ml
- Patients having low risk or no comorbidities and having an age of <65 years with having any 3 out of 4 Fever 0f
- ≥39 C
- Hypotension or drop in mean arterial pressure of > 10mmHg
- Progressive Hypoxemia requiring > 5 liters of oxygen
- Sustained Respiratory rate >30/min With any 2 laboratory parameters out of 3 are present D-dimers ≥ 1000 ng/ml C-reactive protein CRP ≥ 100mg/L Ferritin ≥ 600ng/ml
- Moderate severe or severe COVID 19 features
- Shortness of breath oxygen saturation <93% on room air
- Progressive Hypoxemia requiring > 5 liters of oxygen
- Respiratory rate >30/min
- The partial pressure of arterial oxygen to fraction of inspired oxygen ratio<300
- Lung infiltrates on Chest x-ray CXR >50% within 24 to 48 hrs
- Respiratory failure
Who cannot join
- Known severe allergic reactions to Tocilizumab or any other monoclonal antibody
- Pregnancy or breastfeeding
- Absolute Neutrophil Count(ANC) < 1000
- Alanine aminotransferase(ALT) or aspartate aminotransferase (AST) > 5 times upper normal limit
- Platelet count of < 50,000
- Bowel diverticulitis or bowel perforation
- Patients having Acute pancreatitis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fatima Memorial Hospital College of Medicine & Dentistry
Lahore, Punjab Province, 54000
About this study
Investigators conducted this study to see the effectiveness of Tocilizumab in COVID-19 participants who were in cytokine release syndrome and there was also a control group who received steroids(RECOVERY TRIAL wasn't published or available at that time) this study was conducted in the early days of 1st wave of COVID in our country Pakistan so it was need of the day to develop some national guidelines on the basis of multiple studies' results from Pakistan.
Read the detailed description
Objectives: To analyze the effectiveness of Tocilizumab in moderate to severe Covid-19 participants on the basis of predefined assessment criteria.
Study Settings: Single center, Fatima Memorial Hospital, Lahore.
Study Design: Quasi experimental.
Duration of Study: From 12th May, 2020 to 12th July, 2020.
Participants \& Methods: Sample size and technique: Sample size was 93; 33 participants were kept in experimental group, given Tocilizumab, 8mg/kg intravenously or 162 mg subcutaneously and rest of the 60 participants were given corticosteroids, methylprednisolone 80 mg/day. Consecutive sampling.
Failure of therapy was labeled when participants were intubated or died, and the endpoints were failure-free survival which was the primary endpoint and overall survival secondary at the time of discharge.
- Conditions
- Covid19
- Being tested
- Tocilizumab
- Keywords
- Tocilizumab, Covid-19, SARS-CoV-2
- 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
Also called Experimental
Participants received an initial dose calculated as per the body weight (8mg/kg) maximum 800mg/dose) over 1 hour, followed by up to three additional doses if required as per the response after the first dose with 8 hours intervals. Predefined Parameters of disease severity were assessed 12 to 24 hourly. Injection Paracetamol 1g was administered before infusion. The response of the participants after Tocilizumab administration was recorded based on clinical parameters (Oxygen requirement, Fever, Need for invasive positive pressure ventilation), biochemical parameters (D-dimers, C-reactive protein (CRP), Ferritin, Lactate dehydrogenase (LDH) levels), Chest X-ray findings, and Repeated PCR test for COVID-19. Any side effects noted after administration of TOCILIZUMAB were recorded.
Any side effects noted after administration of TCZ/ Corticosteroid were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab Group | Experimental | Tocilizumab administration protocol: Patients received an initial dose calculated as per the body weight (8mg/kg) maximum 800mg/dose) over 1 hour, followed by up to three additional doses if required as per the response after the first dose with 8 hours intervals. Predefined Parameters of disease severity were assessed 12 to 24 hourly. Injection Paracetamol 1g was administered before infusion. Receives: Drug: Tocilizumab |
| Methylprednisolone (corticosteroid) group | Active comparator | Corticosteroid administration protocol: Patients received methylprednisolone 80mg/day in two divided doses as per national/local guidelines and predefined parameters of disease severity were assessed on each day. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased Mortality in Participants
investigators tried to find out that whether there is decreased mortality in expermiental and active Comparator group or not
Measured: 30 days
Hospital & ICU stay in days
investigators tried to find out that whether there is decreased hospital and ICU stay in experimental group \& active Comparator
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start12 May 2020
- Primary completion12 Jun 2020
- Study completion12 Jun 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 Covid19Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- FMH College of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aijaz Zeeshan Khan Chachar, FMH College of Medicine and Dentistry
- Investigators
- Aijaz Zeeshan Khan Chachar, MBBS,FCPS, Study director, FMH College of Medicine & Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730323
- Sponsor's protocol ID
- IRB# FMH-05-2020-IRB-75
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared with researchers in future too
Publications
Chachar AZK, Khan KA, Iqbal J, Shahid AH, Asif M, Fatima SA, Khan AA, Younis BB. "Tocilizumab-an option for patients with COVID-19 associated cytokine release syndrome: A single center experience", a retrospective study-original article. Ann Med Surg (Lond). 2021 Mar;63:102165. doi: 10.1016/j.amsu.2021.02.011. Epub 2021 Feb 8.
PubMed 33585031
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience
- ClinicalTrials.gov ID
- NCT04730323
- Acronym / sponsor ID
- IRB# FMH-05-2020-IRB-75
- Conditions
- Covid19
- Keywords
- Tocilizumab, Covid-19, SARS-CoV-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- FMH College of Medicine and DentistryUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 29 Jan 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.
Investigators conducted this study to see the effectiveness of Tocilizumab in COVID-19 participants who were in cytokine release syndrome and there was also a control group who received steroids(RECOVERY TRIAL wasn't published or available at that time) this study was conducted in the early days of 1st wave of COVID in our country Pakistan so it was need of the day to develop some national guidelines on the basis of multiple studies' results from Pakistan.
Detailed description
Objectives: To analyze the effectiveness of Tocilizumab in moderate to severe Covid-19 participants on the basis of predefined assessment criteria.
Study Settings: Single center, Fatima Memorial Hospital, Lahore.
Study Design: Quasi experimental.
Duration of Study: From 12th May, 2020 to 12th July, 2020.
Participants \& Methods: Sample size and technique: Sample size was 93; 33 participants were kept in experimental group, given Tocilizumab, 8mg/kg intravenously or 162 mg subcutaneously and rest of the 60 participants were given corticosteroids, methylprednisolone 80 mg/day. Consecutive sampling.
Failure of therapy was labeled when participants were intubated or died, and the endpoints were failure-free survival which was the primary endpoint and overall survival secondary at the time of discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab Group | Experimental | Drug: TocilizumabTocilizumab administration protocol: Patients received an initial dose calculated as per the body weight (8mg/kg) maximum 800mg/dose) over 1 hour, followed by up to three additional doses if required as per the response after the first dose with 8 hours intervals. Predefined Parameters of disease severity were assessed 12 to 24 hourly. Injection Paracetamol 1g was administered before infusion. |
| Methylprednisolone (corticosteroid) group | Active comparator | Drug: TocilizumabCorticosteroid administration protocol: Patients received methylprednisolone 80mg/day in two divided doses as per national/local guidelines and predefined parameters of disease severity were assessed on each day. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| TocilizumabAlso: ExperimentalParticipants received an initial dose calculated as per the body weight (8mg/kg) maximum 800mg/dose) over 1 hour, followed by up to three additional doses if required as per the response after the first dose with 8 hours intervals. Predefined Parameters of disease severity were assessed 12 to 24 hourly. Injection Paracetamol 1g was administered before infusion. The response of the participants after Tocilizumab administration was recorded based on clinical parameters (Oxygen requirement, Fever, Need for invasive positive pressure ventilation), biochemical parameters (D-dimers, C-reactive protein (CRP), Ferritin, Lactate dehydrogenase (LDH) levels), Chest X-ray findings, and Repeated PCR test for COVID-19. Any side effects noted after administration of TOCILIZUMAB were recorded. Any side effects noted after administration of TCZ/ Corticosteroid were recorded. | Drug | Methylprednisolone (corticosteroid) group, Tocilizumab Group |
Primary outcome
Decreased Mortality in Participants
Time frame: 30 days
investigators tried to find out that whether there is decreased mortality in expermiental and active Comparator group or not
Hospital & ICU stay in days
Time frame: 14 days
investigators tried to find out that whether there is decreased hospital and ICU stay in experimental group \& active Comparator
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 29 Jan 2021.
- Derived from this study: PubMed 33585031Chachar AZK, Khan KA, Iqbal J, Shahid AH, Asif M, Fatima SA, Khan AA, Younis BB. "Tocilizumab-an option for patients with COVID-19 associated cytokine release syndrome: A single center experience", a retrospective study-original article. Ann Med Surg (Lond). 2021 Mar;63:102165. doi: 10.1016/j.amsu.2021.02.011. Epub 2021 Feb 8.
- Individual participant dataSharing planned: Yes. IPD can be shared with researchers in future too
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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.
Aijaz Zeeshan Khan Chachar, MBBS,FCPS study director
FMH College of Medicine & Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tocilizumab in people with Covid19, run by FMH College of Medicine and Dentistry 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 19 inclusion and 7 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 29 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Decreased Mortality in Participants (time frame: 30 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?
On the ClinicalTrials.gov record for NCT04730323, 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 29 Jan 2021.