Seven days treatment with the angiotensin II type 2 receptor agonist C21 in hospitalized COVID-19 patients; a placebo-controlled randomised multi-centre double-blind phase 2 trial
| العنوان: | Seven days treatment with the angiotensin II type 2 receptor agonist C21 in hospitalized COVID-19 patients; a placebo-controlled randomised multi-centre double-blind phase 2 trial |
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| المؤلفون: | Kate Westergaard, Joanna C. Porter, Kartikeya Parmar, Göran Tornling, Rohit Batta, Reema Kashiva, Carl-Johan Dalsgaard, Johan Raud, Anne Katrine Cohrt, Anders Hallberg, Thomas Bengtsson, Bryan Williams |
| المصدر: | EClinicalMedicine, Vol 41, Iss, Pp 101152-(2021) EClinicalMedicine |
| بيانات النشر: | Elsevier, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Agonist, medicine.medical_specialty, Infectious Medicine, Medicine (General), medicine.drug_class, medicine.medical_treatment, Phases of clinical research, viral pneumonia, Infektionsmedicin, Placebo, R5-920, Internal medicine, Post-hoc analysis, medicine, Clinical endpoint, angiotensin II type 2 receptor, pharmacologic treatment, Mechanical ventilation, business.industry, Mortality rate, COVID-19, General Medicine, Angiotensin II Type-2 Receptor, acute hospitalizations, business, Research Paper |
| الوصف: | Background: COVID-19 morbidity and mortality remains high and the need for safe and effective drugs continues despite vaccines. Methods: Double-blind, placebo-controlled, multi-centre, randomised, parallel group phase 2 trial to evaluate safety and efficacy of oral angiotensin II type 2 receptor agonist C21 in hospitalized patients with COVID-19 and CRP ≥ 50-150 mg/L conducted at eight sites in India (NCT04452435). Patients were randomly assigned 100 mg C21 bid or placebo for 7 days in addition to standard of care. Primary endpoint: reduction in CRP. The study period was 21 July to 13 October 2020. Findings: 106 patients were randomised and included in the analysis (51 C21, 55 placebo). There was no significant group difference in reduction of CRP, 81% and 78% in the C21 and placebo groups, respectively, with a treatment effect ratio of 0.85 [90% CI 0.57, 1.26]. In a secondary analysis in patients requiring supplemental oxygen at randomisation, CRP was reduced in the C21 group compared to placebo. At the end of the 7-day treatment, 37 (72.5%) and 30 (54.5%) of the patients did not require supplemental oxygen in the C21 and placebo group, respectively (OR 2.20 [90% CI 1.12, 4.41]). A post hoc analysis showed that at day 14, the proportion of patients not requiring supplemental oxygen was 98% and 80% in the C21 group compared to placebo (OR 12.5 [90% CI 2.9, 126]). Fewer patients required mechanical ventilation (one C21 patient; four placebo patients), and C21 was associated with a numerical reduction in the mortality rate (one vs three in the C21 and placebo group, respectively). Treatment with C21 was safe and well tolerated. Interpretation: Among hospitalised patients with COVID-19 receiving C21 for 7 days there was no reduction in CRP compared to placebo. However, a post-hoc analysis indicated a marked reduction of requirement for oxygen at day 14. The day 14 results from this study justify further evaluation in a Phase 3 study and such a trial is currently underway. Funding: Vicore Pharma AB and LifeArc, UK. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2589-5370 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::094fa0b0fc937db077ee7514035c365c http://www.sciencedirect.com/science/article/pii/S2589537021004326 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....094fa0b0fc937db077ee7514035c365c |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 25895370 |
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