Acute Respiratory Distress SyndromePhase 2NCT04475588
Efficacy and Safety of Itolizumab in COVID-19 Complications
A Phase 2 study testing Itolizumab IV infusion in people with Acute Respiratory Distress Syndrome and Cytokine Release Syndrome, run by Biocon Limited at 4 sites in India.
Trial summary
Randomized, Parallel Group, Active Controlled Trial Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19
- What is being tested?
- Itolizumab IV infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesIndia
- Study dates
- 1 May 2020to 7 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults above 18 years (not tested in children yet)
- Informed consent for participation in the study
- Virological diagnosis of SARS-CoV2 infection (PCR)
- Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection
- Oxygen saturation at rest in ambient air ≤94%
- Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of < 200
Who cannot join
- Known severe allergic reactions to monoclonal antibodies
- Active tuberculosis (TB) infection
- History of inadequately treated tuberculosis or latent tuberculosis
- In the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments
- Have received oral anti-rejection or immune-suppressive drugs within the past 6 months
- Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
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- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
- Patients with known history of Hepatitis B, Hepatitis C or HIV
- Absolute Neutrophils count (ANC) <1000 / mm3
- Platelets <50,000 / mm3
- Absolute Lymphocyte count (ALC): <500/mm3
Trial locations and contacts
4 sites in 1 country.
India4 sites
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
Mumbai, 400008
Seth GS Medical College and KEM Hospital
Mumbai, 400012
MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital
New Delhi, 110002
All India Institute Of Medical Sciences
New Delhi, 110029
About this study
Official title: A Multi-Centre, Open Label, Two Arm Randomized, Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications
Randomized, Parallel Group, Active Controlled Trial
Read the detailed description
This is a Multi-Centric, Open label, Two Arm Randomized, Phase 2 Study.
All eligible patients entering into the study will be randomized in 2:1 ratio to receive the treatment A (Best supportive care + Itolizumab) / B (Best supportive care) respectively. Each patient will undergo the treatment based on their assigned treatment for a month along with battery of tests that includes, but not limited to, cytokines and chemokine, along with recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals -pulse, BP, RR; Temperature, PaO2/FiO2, MAP, GCS.
As Itolizumab is an investigational drug, the benefit to COVID-19 patients experiencing complications such as Cytokine Release Syndrome is not known. However, findings from this study may be beneficial to the society at a large at the National and International Level.
- Being tested
- Itolizumab IV infusion, Best supportive care (BSC)
- Medical subject headings
- Respiratory Distress Syndrome, Cytokine Release Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itolizumab IV infusionDrug
First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.
BSC: similar to Arm B
Best supportive care (BSC)Drug
Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Itolizumab + BSC | Experimental | Not described Receives: Drug: Itolizumab IV infusion; Drug: Best supportive care (BSC) |
| Arm B - Best supportive care (BSC) | Active comparator | Not described Receives: Drug: Best supportive care (BSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-month Mortality Rate Between the Two Arms
1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30
Measured: One-month
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Stable SpO2: Defined as number of patients with absence of increase in FiO2 to maintain SpO2 ≥ 92% Improvement of SpO2: Defined as number of patients with decrease in FiO2 to maintain SpO2 > 92%
Measured: Day 7, Day 14, Day 21 & Day 30
Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)
Number of patients needing Intubation/IMV post treatment
Measured: Day 30
Reduction in Proportion of Patients on Non-invasive Ventilation
Reduction in proportion of Patients on Non-invasive Ventilation: defined as number of patient improved and shifted to Face mask, Nasal cannula, non-rebreather mask or off oxygen over time
Measured: Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Stable PaO2: Defined as number of patients with up to 10% change in PaO2/FiO2 ratio from baseline.
Improvement of PaO2: Defined as number of patients with > 10% improvement in PaO2/FiO2 ratio from baseline (including patients weaned off oxygen).
Measured: Day 7, Day14, Day 21 & Day30
Reduction in Proportion of Patients- Invasive Mechanical Ventilation
Patient improved from invasive ventilation over time from baseline.
Measured: Day7, Day14, Day21 & Day 30
Reduction in Proportion of Patients-High Flow Nasal Oxygen
Patient improved from High Flow Nasal Oxygen over time from baseline.
Measured: Day7 ,Day 14 ,Day 21, Day 30
Mean Change From Baseline in Ferritin
Mean Change from Baseline in Ferritin
Measured: Day 7, Day 14, Day 21 & Day 30
Mean Change From Baseline in LDH
Mean Change from Baseline in LDH
Measured: Day 7, Day14, Day 21 and Day 30.
Mean Change From Baseline in CRP (C-reactive Protein)
Mean Change from Baseline in CRP
Measured: Day 7, Day 14, Day 21 & Day 30
Mean Change From Baseline D-Dimer
Measured: Day 7, Day 14, Day 21 & Day 30
Secondary outcomes (4)
Mean Change From Baseline of Absolute Lymphocyte Count
Mean change From baseline in Lymphocyte count
Measured: day 7, day 14 ,day 21 & day 30
Biomarkers (IL-6, TNF-a)
Mean values of Pre and Post 1st and 2nd dose are shown
Measured: Pre and Post 1st dose; Pre and Post 2nd dose
Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio)
Mean PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)
Measured: Baseline, Day 7, Day 14, Day 21 & Day 30
Number and Percentage of Patients With Radiological Response
Number of patients with improved X ray/CT findings as compared to baseline or returned to normal in the last assessment
Measured: up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 May 2020
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory Distress 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475588
- Sponsor's protocol ID
- ITOLI-C19-02-I-00
- Status last verified
- Jun 2021
- First submitted
- 16 Jul 2020
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open Label, Two Arm Randomized, Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications
- ClinicalTrials.gov ID
- NCT04475588
- Acronym / sponsor ID
- ITOLI-C19-02-I-00
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Biocon LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 May 2020 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Posted 20 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, Parallel Group, Active Controlled Trial
Detailed description
This is a Multi-Centric, Open label, Two Arm Randomized, Phase 2 Study.
All eligible patients entering into the study will be randomized in 2:1 ratio to receive the treatment A (Best supportive care + Itolizumab) / B (Best supportive care) respectively. Each patient will undergo the treatment based on their assigned treatment for a month along with battery of tests that includes, but not limited to, cytokines and chemokine, along with recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals -pulse, BP, RR; Temperature, PaO2/FiO2, MAP, GCS.
As Itolizumab is an investigational drug, the benefit to COVID-19 patients experiencing complications such as Cytokine Release Syndrome is not known. However, findings from this study may be beneficial to the society at a large at the National and International Level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Itolizumab + BSC | Experimental | Drug: Itolizumab IV infusion, Drug: Best supportive care (BSC) |
| Arm B - Best supportive care (BSC) | Active comparator | Drug: Best supportive care (BSC) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female adults above 18 years (not tested in children yet)
- Informed consent for participation in the study
- Virological diagnosis of SARS-CoV2 infection (PCR)
- Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection
- Oxygen saturation at rest in ambient air ≤94%
Key exclusion criteria (11 listed)
- Known severe allergic reactions to monoclonal antibodies
- Active tuberculosis (TB) infection
- History of inadequately treated tuberculosis or latent tuberculosis
- In the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments
- Have received oral anti-rejection or immune-suppressive drugs 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 |
|---|---|---|
| Itolizumab IV infusionFirst dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks. BSC: similar to Arm B | Drug | Arm A - Itolizumab + BSC |
| Best supportive care (BSC)Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc | Drug | Arm A - Itolizumab + BSC, Arm B - Best supportive care (BSC) |
Primary outcome
One-month Mortality Rate Between the Two Arms
Time frame: One-month
1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30
Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2
Time frame: Day 7, Day 14, Day 21 & Day 30
Stable SpO2: Defined as number of patients with absence of increase in FiO2 to maintain SpO2 ≥ 92% Improvement of SpO2: Defined as number of patients with decrease in FiO2 to maintain SpO2 > 92%
Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)
Time frame: Day 30
Number of patients needing Intubation/IMV post treatment
Reduction in Proportion of Patients on Non-invasive Ventilation
Time frame: Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30
Reduction in proportion of Patients on Non-invasive Ventilation: defined as number of patient improved and shifted to Face mask, Nasal cannula, non-rebreather mask or off oxygen over time
Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2
Time frame: Day 7, Day14, Day 21 & Day30
Stable PaO2: Defined as number of patients with up to 10% change in PaO2/FiO2 ratio from baseline. Improvement of PaO2: Defined as number of patients with > 10% improvement in PaO2/FiO2 ratio from baseline (including patients weaned off oxygen).
Reduction in Proportion of Patients- Invasive Mechanical Ventilation
Time frame: Day7, Day14, Day21 & Day 30
Patient improved from invasive ventilation over time from baseline.
Reduction in Proportion of Patients-High Flow Nasal Oxygen
Time frame: Day7 ,Day 14 ,Day 21, Day 30
Patient improved from High Flow Nasal Oxygen over time from baseline.
Mean Change From Baseline in Ferritin
Time frame: Day 7, Day 14, Day 21 & Day 30
Mean Change from Baseline in Ferritin
Mean Change From Baseline in LDH
Time frame: Day 7, Day14, Day 21 and Day 30.
Mean Change from Baseline in LDH
Mean Change From Baseline in CRP (C-reactive Protein)
Time frame: Day 7, Day 14, Day 21 & Day 30
Mean Change from Baseline in CRP
Mean Change From Baseline D-Dimer
Time frame: Day 7, Day 14, Day 21 & Day 30
4 secondary outcomes
Mean Change From Baseline of Absolute Lymphocyte Count
Time frame: day 7, day 14 ,day 21 & day 30
Biomarkers (IL-6, TNF-a)
Time frame: Pre and Post 1st dose; Pre and Post 2nd dose
Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio)
Time frame: Baseline, Day 7, Day 14, Day 21 & Day 30
Number and Percentage of Patients With Radiological Response
Time frame: up to Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itolizumab IV infusion in people with Acute Respiratory Distress Syndrome and Cytokine Release Syndrome, run by Biocon Limited at 4 sites in India.
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 6 inclusion and 11 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. 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?
Yes. Results are posted in the registry (first posted 20 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
One-month Mortality Rate Between the Two Arms (time frame: One-month). The study lists 11 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 14 Jun 2021.