Trial · NCT04475588
Efficacy and Safety of Itolizumab in COVID-19 Complications
NCT04475588, Phase 2, Completed, Biocon Limited; results first posted 2021-05-20
3 sourcestrials-2026-11-12-0.5.0
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Cite this record
ConductScience Library. Efficacy and Safety of Itolizumab in COVID-19 Complications. Trials, record NCT04475588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04475588
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Itolizumab in COVID-19 Complications
- NCT number
- NCT04475588
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Biocon Limited
- Conditions
- Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19
- Interventions
- Itolizumab IV infusion, Best supportive care (BSC)
- First posted
- 2020-07-17
- Last updated
- 2021-06-14
- Results first posted
- 2021-05-20
- Limitations and caveats
Due to current pandemic situation few datapoints not available for ptxs who got discharged earlier basis clinical status \& bed shortage. As time to discharge was influenced by load on the hospital it was not an evaluable parameter after the trial.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | One-month Mortality Rate Between the Two Arms | One-month | 1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30 |
| Primary | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | 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% |
| Primary | Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV) | Day 30 | Number of patients needing Intubation/IMV post treatment |
| Primary | Reduction in Proportion of Patients on Non-invasive Ventilation | 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 |
| Primary | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | 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). |
| Primary | Reduction in Proportion of Patients- Invasive Mechanical Ventilation | Day7, Day14, Day21 & Day 30 | Patient improved from invasive ventilation over time from baseline. |
| Primary | Reduction in Proportion of Patients-High Flow Nasal Oxygen | Day7 ,Day 14 ,Day 21, Day 30 | Patient improved from High Flow Nasal Oxygen over time from baseline. |
| Primary | Mean Change From Baseline in Ferritin | Day 7, Day 14, Day 21 & Day 30 | Mean Change from Baseline in Ferritin |
| Primary | Mean Change From Baseline in LDH | Day 7, Day14, Day 21 and Day 30. | Mean Change from Baseline in LDH |
| Primary | Mean Change From Baseline in CRP (C-reactive Protein) | Day 7, Day 14, Day 21 & Day 30 | Mean Change from Baseline in CRP |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | One-month Mortality Rate Between the Two Arms | One-month | participants | NUMBER | |
| PRIMARY | Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Day 7, Day 14, Day 21 & Day 30 | Patients improved/ weaned off O2, the observation was carried forward | participants | NUMBER |
| PRIMARY | Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV) | Day 30 | participants | NUMBER | |
| PRIMARY | Reduction in Proportion of Patients on Non-invasive Ventilation | Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30 | participants | NUMBER | |
| PRIMARY | Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2 | Day 7, Day14, Day 21 & Day30 | Patients improved/ weaned off O2, the observation was carried forward. | participants | NUMBER |
| PRIMARY | Reduction in Proportion of Patients- Invasive Mechanical Ventilation | Day7, Day14, Day21 & Day 30 | There were no patients on invasive mechanical ventilation at baseline | ||
| PRIMARY | Reduction in Proportion of Patients-High Flow Nasal Oxygen | Day7 ,Day 14 ,Day 21, Day 30 | There were no patients on High Flow Nasal Oxygen at baseline | ||
| PRIMARY | Mean Change From Baseline in Ferritin | Day 7, Day 14, Day 21 & Day 30 | only observed values were used. | ng/mL | MEAN |
| PRIMARY | Mean Change From Baseline in LDH | Day 7, Day14, Day 21 and Day 30. | Only observed values were used. | U/L | MEAN |
| PRIMARY | Mean Change From Baseline in CRP (C-reactive Protein) | Day 7, Day 14, Day 21 & Day 30 | Only observed values were used. | mg/L | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group97
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| One-month Mortality Rate Between the Two Arms | Arm A - Itolizumab + BSC | 0 | participants | ||
| One-month Mortality Rate Between the Two Arms | Arm B - Best Supportive Care (BSC) | 3 | participants | ||
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Arm A - Itolizumab + BSC | Day 7 | 17 | participants | |
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Arm B - Best Supportive Care (BSC) | Day 7 | 5 | participants | |
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Arm A - Itolizumab + BSC | Day 14 | 19 | participants | |
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Arm B - Best Supportive Care (BSC) | Day 14 | 7 | participants | |
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Arm A - Itolizumab + BSC | Day 21 | 20 | participants | |
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Arm B - Best Supportive Care (BSC) | Day 21 | 7 | participants | |
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Arm A - Itolizumab + BSC | Day 30/EOS | 20 | participants | |
| Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2 | Arm B - Best Supportive Care (BSC) | Day 30/EOS | 7 | participants |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A - Itolizumab + BSC | 22 | |
| Overall Study | STARTED | Arm B - Best Supportive Care (BSC) | 10 | |
| Overall Study | COMPLETED | Arm A - Itolizumab + BSC | 20 | |
| Overall Study | COMPLETED | Arm B - Best Supportive Care (BSC) | 10 | |
| Overall Study | NOT COMPLETED | Arm A - Itolizumab + BSC | 2 | |
| Overall Study | NOT COMPLETED | Arm B - Best Supportive Care (BSC) | 0 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sinus tachycardia | Cardiac disorders | Arm A - Itolizumab + BSC | 1 | 22 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Arm B - Best Supportive Care (BSC) | 0 | 10 | 0 |
| other | Hypothyroidism | Endocrine disorders | Arm A - Itolizumab + BSC | 1 | 22 | 1 |
| other | Hypothyroidism | Endocrine disorders | Arm B - Best Supportive Care (BSC) | 0 | 10 | 0 |
| other | Constipation | Gastrointestinal disorders | Arm A - Itolizumab + BSC | 1 | 22 | 1 |
| other | Constipation | Gastrointestinal disorders | Arm B - Best Supportive Care (BSC) | 0 | 10 | 0 |
| other | Chills | General disorders | Arm A - Itolizumab + BSC | 5 | 22 | 6 |
| other | Chills | General disorders | Arm B - Best Supportive Care (BSC) | 0 | 10 | 0 |
| other | Urinary tract infection | Infections and infestations | Arm A - Itolizumab + BSC | 1 | 22 | 1 |
| other | Urinary tract infection | Infections and infestations | Arm B - Best Supportive Care (BSC) | 0 | 10 | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A - Itolizumab + BSC | 1 | 22 |
| Total, all-cause mortality | Arm B - Best Supportive Care (BSC) | 3 | 10 |
| Total, other adverse events | Arm A - Itolizumab + BSC | 18 | 22 |
| Total, other adverse events | Arm B - Best Supportive Care (BSC) | 4 | 10 |
| Total, serious adverse events | Arm A - Itolizumab + BSC | 3 | 22 |
| Total, serious adverse events | Arm B - Best Supportive Care (BSC) | 3 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A - Itolizumab + BSC vs Arm B - Best Supportive Care (BSC): One-month Mortality Rate Between the Two Arms | Trial comparisons |
| Arm A - Itolizumab + BSC vs Arm B - Best Supportive Care (BSC): Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV) | Trial comparisons |
| Arm A - Itolizumab + BSC vs Arm B - Best Supportive Care (BSC): Number and Percentage of Patients With Radiological Response | Trial comparisons |
| Arm A - Itolizumab + BSC vs Arm B - Best Supportive Care (BSC): deaths from any cause | Trial comparisons |
| Arm A - Itolizumab + BSC vs Arm B - Best Supportive Care (BSC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04475588
GET https://conductscience.org/api/trials/v1/NCT04475588/results?page=2