CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Itolizumab IV infusion +1 moredrug
Likely dose
Itolizumab IV infusion 1.6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04475588
NCT04475588Phase 2Completed
CompareCT.gov

A Multi-Centre, Open Label, Two Arm Randomized, Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications

Biocon Limited·interventional·Posted Jul 17, 2020·Updated Jun 14, 2021

In Brief

A Phase 2 clinical trial evaluating Itolizumab IV infusion and Best supportive care (BSC) for Acute Respiratory Distress Syndrome and 2 related conditions. Completed, enrolled 32 participants across 4 sites.

Detailed Summary

Randomized, Parallel Group, Active Controlled Trial

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19
CountriesIndia
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 17, 2020
Enrollment StartMay 1, 2020
Primary CompletionJul 7, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.0 years ago

Interventions

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