REcovery and SURvival of patients with moderate to severe acute REspiratory distress syndrome (ARDS) due to COVID-19 : a multicenter, single-arm, Phase IV itolizumab Trial: RESURRECT
BACKGROUND: Itolizumab, an anti-CD6 monoclonal antibody, down-regulates COVID-19-mediated inflammation and the acute effects of cytokine release syndrome. This study aimed to evaluate the safety and efficacy of itolizumab in hospitalized COVID-19 patients with PaO2/FiO2 ratio (PFR) ≤200 requiring oxygen therapy.
RESEARCH DESIGN AND METHODS: This multicenter, single-arm, Phase 4 study enrolled 300 hospitalized adults with SARS-CoV-2 infection, PFR ≤200, oxygen saturation ≤94%, and ≥1 elevated inflammatory markers from 17 COVID-19 specific tertiary Indian hospitals. Patients received 1.6 mg/kg of itolizumab infusion, were assessed for 1 month, and followed-up to Day 90. Primary outcome measures included incidence of severe acute infusion-related reactions (IRRs) (≥Grade-3) and mortality rate at 1 month.
RESULTS: Incidence of severe acute IRRs was 1.3% and mortality rate at 1 month was 6.7% (n = 20/300). Mortality rate at Day 90 was 8.0% (n = 24/300). By Day 7, most patients had stable/improved SpO2 without increasing FiO2 and by Day 30, 91.7% patients were off oxygen therapy. Overall, 63 and 10 patients, respectively, reported 123 and 11 treatment-emergent adverse events up to Days 30 and 90. No deaths were attributable to itolizumab. Patient-reported outcomes showed gradual and significant improvement for all five dimensions on EQ-5D-5L.
CONCLUSION: Itolizumab demonstrated acceptable safety with a favorable prognosis in hospitalized COVID-19 patients.
CLINICAL TRIAL REGISTRATION: CTRI/2020/09/027941 (Clinical Trials Registry of India).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
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| Enthalten in: |
Expert opinion on biological therapy - 23(2023), 5 vom: 21. Mai, Seite 443-454 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kr, Raveendra [VerfasserIn] |
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| Links: |
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| Themen: |
Acute respiratory distress syndrome |
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| Anmerkungen: |
Date Completed 30.05.2023 Date Revised 30.05.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/14712598.2023.2204186 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM355776006 |
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| 245 | 1 | 0 | |a REcovery and SURvival of patients with moderate to severe acute REspiratory distress syndrome (ARDS) due to COVID-19 |b a multicenter, single-arm, Phase IV itolizumab Trial: RESURRECT |
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| 500 | |a Date Revised 30.05.2023 | ||
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Itolizumab, an anti-CD6 monoclonal antibody, down-regulates COVID-19-mediated inflammation and the acute effects of cytokine release syndrome. This study aimed to evaluate the safety and efficacy of itolizumab in hospitalized COVID-19 patients with PaO2/FiO2 ratio (PFR) ≤200 requiring oxygen therapy | ||
| 520 | |a RESEARCH DESIGN AND METHODS: This multicenter, single-arm, Phase 4 study enrolled 300 hospitalized adults with SARS-CoV-2 infection, PFR ≤200, oxygen saturation ≤94%, and ≥1 elevated inflammatory markers from 17 COVID-19 specific tertiary Indian hospitals. Patients received 1.6 mg/kg of itolizumab infusion, were assessed for 1 month, and followed-up to Day 90. Primary outcome measures included incidence of severe acute infusion-related reactions (IRRs) (≥Grade-3) and mortality rate at 1 month | ||
| 520 | |a RESULTS: Incidence of severe acute IRRs was 1.3% and mortality rate at 1 month was 6.7% (n = 20/300). Mortality rate at Day 90 was 8.0% (n = 24/300). By Day 7, most patients had stable/improved SpO2 without increasing FiO2 and by Day 30, 91.7% patients were off oxygen therapy. Overall, 63 and 10 patients, respectively, reported 123 and 11 treatment-emergent adverse events up to Days 30 and 90. No deaths were attributable to itolizumab. Patient-reported outcomes showed gradual and significant improvement for all five dimensions on EQ-5D-5L | ||
| 520 | |a CONCLUSION: Itolizumab demonstrated acceptable safety with a favorable prognosis in hospitalized COVID-19 patients | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: CTRI/2020/09/027941 (Clinical Trials Registry of India) | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Acute respiratory distress syndrome | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a anti-CD6 | |
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| 700 | 1 | |a Deodhar, Sarika |e verfasserin |4 aut | |
| 700 | 1 | |a A, Radhika |e verfasserin |4 aut | |
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| 700 | 1 | |a Vaidyanathan, Sivakumar |e verfasserin |4 aut | |
| 700 | 1 | |a Athalye, Sandeep Nilkanth |e verfasserin |4 aut | |
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