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To study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by COVID-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SoC) | Active Comparator |
| |
| SoC + Icatibant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firazyr | Drug | Icatibant 10 MG/ML Prefilled Syringe |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of experimental treatment | Number of patients reaching grade 2 (inpatient, no longer requiring supplemental oxygen and no longer requiring care or grade 1 (hospital discharge) of the ordinal scale of the clinical state of the patient for 48 hours. | up to 10 days |
| Safety of experimental treatment | Number of patients without an adverse reaction scoring 3, 4 or 5 according to the Criteria of Adverse Event Terminology (CTC-AE). | up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term efficacy | Number (percentage) of patients who reach grade 2 or grade 1 during the 10 days of to have initiated treatment. | up to 10 days |
| Time to achive a clinical response | period time (days) between visit 1 (treatment start visit) and the day of gathering sustained 48-hour grade 2, grade 1 or grade 0 classification on the WHO 8-point ordinal scale for clinical status assessment The patient must be discharged from the hospital by the 28th day without a relapse or comorbidity related to COVID-19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25666515 | Background | Bova M, Guilarte M, Sala-Cunill A, Borrelli P, Rizzelli GM, Zanichelli A. Treatment of ACEI-related angioedema with icatibant: a case series. Intern Emerg Med. 2015 Apr;10(3):345-50. doi: 10.1007/s11739-015-1205-9. Epub 2015 Feb 10. | |
| 32187470 | Background | Busse PJ, Christiansen SC. Hereditary Angioedema. N Engl J Med. 2020 Mar 19;382(12):1136-1148. doi: 10.1056/NEJMra1808012. No abstract available. |
| Label | URL |
|---|---|
| COVID19, WHO | View source |
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| ID | Term |
|---|---|
| C065679 | icatibant |
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| SoC |
| Other |
The SoC could include respiratory support measures, fluid therapy, antipyretic treatment, postural measures, low-molecular-weight-heparins, corticosteroids, such as dexamethasone, remdesivir and other therapeutic options |
|
| up to 40 days |
| Time to achive an afebrile state | period time (days) to reach a 48-hour sustained afebrile state (i.e., body temperature ≤ 37.5ºC) without antipyretic medication. | up to 40 days |
| time from symptom onset to treatment | period time (days) between the first COVID-19-related symptom and visit 1 (treatment start visit). | up to day 1 |
| Responders | Number (percentage) of patients considered as responders based on National Early Warning Score 2 (NEWS 2) | up to 40 days |
| COVID-19 related relapse | number (and percentage) of patients discharged who presents any COVID-19-related relapse or comorbidity | up to 40 days |
| Patients with Adverse Events | number of patients with Any Adverse Events | up to 40 days |
| Adverse Events | Number of Adverse Events | up to 40 days |
| Serious Adverse Events | Number of Serious Adverse Events | up to 40 days |
| Overall mortality | number of patients who died | up to 40 days |
| COVID-19 related mortality | number of patients who died due to COVID-19 | up to 40 days |
| Time until death | number of days from visit 1 until death | up to 40 days |
| COVID-19-related complications | number of patients who had any COVID-19 related complications | up to 40 days |
| Patients requiring intensive care | number of patients who require intensive care | up to 40 days |
| patients requiring intensive care and invasive mechanical ventilation | number of patients who require intensive care and invasive mechanical ventilation | up to 40 days |
| patients requiring oxygen supplementation | number of patients who require oxygen supplementation from hospital discharge up until visit 7 | up to 40 days |
| Patients with nonsocomial infection | number (and percentage) of patients diagnosed with another nosocomial infection | up to 40 days |
| Rehospitalizations | number (and percentage) of patients who requires hospital readmission within 28 (± 3) days from hospital discharge | up to 40 days |
| 31360439 | Background | Bygum A, Caballero T, Grumach AS, Longhurst HJ, Bouillet L, Aberer W, Zanichelli A, Botha J, Andresen I, Maurer M; IOS Study Group. Elderly versus younger patients with hereditary angioedema type I/II: patient characteristics and safety analysis from the Icatibant Outcome Survey. Clin Transl Allergy. 2019 Jul 19;9:37. doi: 10.1186/s13601-019-0272-9. eCollection 2019. |
| 20818888 | Background | Cicardi M, Banerji A, Bracho F, Malbran A, Rosenkranz B, Riedl M, Bork K, Lumry W, Aberer W, Bier H, Bas M, Greve J, Hoffmann TK, Farkas H, Reshef A, Ritchie B, Yang W, Grabbe J, Kivity S, Kreuz W, Levy RJ, Luger T, Obtulowicz K, Schmid-Grendelmeier P, Bull C, Sitkauskiene B, Smith WB, Toubi E, Werner S, Anne S, Bjorkander J, Bouillet L, Cillari E, Hurewitz D, Jacobson KW, Katelaris CH, Maurer M, Merk H, Bernstein JA, Feighery C, Floccard B, Gleich G, Hebert J, Kaatz M, Keith P, Kirkpatrick CH, Langton D, Martin L, Pichler C, Resnick D, Wombolt D, Fernandez Romero DS, Zanichelli A, Arcoleo F, Knolle J, Kravec I, Dong L, Zimmermann J, Rosen K, Fan WT. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):532-41. doi: 10.1056/NEJMoa0906393. |
| 1244564 | Background | Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580. |
| 32348166 | Background | Yang G, Tan Z, Zhou L, Yang M, Peng L, Liu J, Cai J, Yang R, Han J, Huang Y, He S. Effects of Angiotensin II Receptor Blockers and ACE (Angiotensin-Converting Enzyme) Inhibitors on Virus Infection, Inflammatory Status, and Clinical Outcomes in Patients With COVID-19 and Hypertension: A Single-Center Retrospective Study. Hypertension. 2020 Jul;76(1):51-58. doi: 10.1161/HYPERTENSIONAHA.120.15143. Epub 2020 Apr 29. |
| 28816340 | Background | Hess R, Wujak L, Hesse C, Sewald K, Jonigk D, Warnecke G, Fieguth HG, de Maat S, Maas C, Bonella F, Preissner KT, Weiss B, Schaefer L, Kuebler WM, Markart P, Wygrecka M. Coagulation factor XII regulates inflammatory responses in human lungs. Thromb Haemost. 2017 Oct 5;117(10):1896-1907. doi: 10.1160/TH16-12-0904. Epub 2017 Aug 17. |
| 27128215 | Background | Leach JK, Spencer K, Mascelli M, McCauley TG. Pharmacokinetics of single and repeat doses of icatibant. Clin Pharmacol Drug Dev. 2015 Mar;4(2):105-11. doi: 10.1002/cpdd.138. Epub 2015 Feb 2. |
| 32362390 | Background | Siddiqi HK, Mehra MR. COVID-19 illness in native and immunosuppressed states: A clinical-therapeutic staging proposal. J Heart Lung Transplant. 2020 May;39(5):405-407. doi: 10.1016/j.healun.2020.03.012. Epub 2020 Mar 20. No abstract available. |
| Background | Van De Veerdonk FL, Netea MG, van Deuren M, van der Meer JWM, de Mast Q, Brüggemann RJ, van der Hoeven H. Kinins and cytokines in COVID-19: a comprehensive pathophysiological approach. 10.20944/preprints202004.0023.v1. |
| 32029004 | Background | Jin YH, Cai L, Cheng ZS, Cheng H, Deng T, Fan YP, Fang C, Huang D, Huang LQ, Huang Q, Han Y, Hu B, Hu F, Li BH, Li YR, Liang K, Lin LK, Luo LS, Ma J, Ma LL, Peng ZY, Pan YB, Pan ZY, Ren XQ, Sun HM, Wang Y, Wang YY, Weng H, Wei CJ, Wu DF, Xia J, Xiong Y, Xu HB, Yao XM, Yuan YF, Ye TS, Zhang XC, Zhang YW, Zhang YG, Zhang HM, Zhao Y, Zhao MJ, Zi H, Zeng XT, Wang YY, Wang XH; , for the Zhongnan Hospital of Wuhan University Novel Coronavirus Management and Research Team, Evidence-Based Medicine Chapter of China International Exchange and Promotive Association for Medical and Health Care (CPAM). A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version). Mil Med Res. 2020 Feb 6;7(1):4. doi: 10.1186/s40779-020-0233-6. |
| 27926986 | Background | Zanichelli A, Maurer M, Aberer W, Caballero T, Longhurst HJ, Bouillet L, Fabien V, Andresen I; IOS Study Group. Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice. Allergy. 2017 Jun;72(6):994-998. doi: 10.1111/all.13103. Epub 2017 Mar 13. |
| 31978945 | Background | Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. |
| 32171076 | Background | Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. |
| 36610464 | Derived | Malchair P, Giol J, Garcia V, Rodriguez O, Ruibal JC, Zarauza A, Llopis F, Matellan L, Bernal T, Solis B, Otero A, Carnaval T, Jofre H, Jacob J, Solanich X, Antoli A, Rocamora G, Videla S. Three-Day Icatibant on Top of Standard Care in Patients With Coronavirus Disease 2019 Pneumonia: A Randomized, Open-Label, Phase 2, Proof-of-Concept Trial. Clin Infect Dis. 2023 May 24;76(10):1784-1792. doi: 10.1093/cid/ciac984. |
| 35413921 | Derived | Malchair P, Otero A, Giol J, Solanich X, Carnaval T, Fernandez-Nistal A, Sanchez-Gabriel A, Montoto C, Lleonart R, Videla S; ICAT-COVID team. A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID). Trials. 2022 Apr 12;23(1):303. doi: 10.1186/s13063-022-06219-7. |
| Icatibant (Firazyr®). Ficha técnica, Febrero 2019. | View source |