Trials / Completed
CompletedNCT04475588
Efficacy and Safety of Itolizumab in COVID-19 Complications
A Multi-Centre, Open Label, Two Arm Randomized, Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Biocon Limited · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Itolizumab IV infusion | 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 |
| DRUG | Best supportive care (BSC) | Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc |
Timeline
- Start date
- 2020-05-01
- Primary completion
- 2020-07-07
- Completion
- 2020-07-07
- First posted
- 2020-07-17
- Last updated
- 2021-06-14
- Results posted
- 2021-05-20
Locations
4 sites across 1 country: India
Source: ClinicalTrials.gov record NCT04475588. Inclusion in this directory is not an endorsement.