ISRCTN30564012已完成3 期
A randomised double-blind placebo-controlled trial of brensocatib (INS1007) in patients with severe COVID-19
niversity of Dundee0 个研究点目标入组 406 人开始时间: 2020年5月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 406
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36075243/ (added 09/09/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 10/11/2020:
- •1. Aged =16 years
- •2. SARS-CoV-2 infection (clinically suspected+ or laboratory confirmed*).
- •3. Admitted to hospital as in-patient less than 96 hours prior to randomisation^
- •4. Illness of any duration, and at least one of the following:
- •4.1. Radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (CT) scan) OR
- •4.2. Evidence of rales/crackles on physical examination OR
- •4.3. Peripheral capillary oxygen saturation (SpO2) =94% on room air prior to randomization OR
- •4.4. Requiring supplemental oxygen OR
- •4.5. Lymphocyte count <1 x 10(9) cells/l
- •5. Participant (or legally authorized representative) provides written informed consent
- •6. Able to take oral medication
- •7. Participant (or legally authorised representative) understands and agrees to comply with planned trial procedures
- •*Laboratory-confirmed: SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 96 hours prior to randomization.
- •+Clinically suspected: in general, SARS-CoV-2 infection should be suspected when a patient presents with (i) typical symptoms (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and (ii) compatible chest X-ray findings (consolidation or ground-glass shadowing); and (iii) alternative causes have been considered
- •unlikely or excluded (e.g. heart failure, influenza). However, the diagnosis remains a clinical one based on the opinion of the managing doctor.
- •^Where a patient has been admitted to hospital for a non COVID-19 reason and develops COVID19 symptoms whilst an in-patient, randomisation may occur up to 96 hours from onset of symptoms.
- •Previous inclusion criteria:
- •1. Aged =16 years
- •2. Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 96 h prior to randomization
- •3. Admitted to hospital as in-patient
- •4. Illness of any duration, and at least one of the following:
- •4.1. Radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (CT) scan) OR
- •4.2. Evidence of rales/crackles on physical examination OR
- •4.3. Peripheral capillary oxygen saturation (SpO2) =94% on room air prior to randomization OR
- •4.4. Requiring supplemental oxygen OR
- •4.5. Lymphocyte count <1 x 10(9) cells/l
- •5. Participant (or legally authorized representative) provides written informed consent
- •6. Able to take oral medication
- •7. Participant (or legally authorised representative) understands and agrees to comply with planned trial procedures
排除标准
- •Current exclusion criteria as of 21/01/2021:
- •1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 times the upper limit of normal, result within 72 hours of randomization (the result closest to randomization should be used if several results are available).
- •2. History of severe liver disease
- •3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30), result within 72 hours of randomization (the result closest to randomization should be used if several results are available)
- •4. Absolute neutrophil count less than 1.0 x 109 cells per L within 72 hours of randomization (the result closest to randomization should be used if several results are available)
- •5. Current treatments with potent Cyp3A4 inducers/inhibitors (e.g Itraconazole, Ketoconazole, diltiazem, verapamil, phenytoin or rifampicin)
- •6. HIV treatments - current treatment with protease/integrase inhibitors or non-nucleoside reverse transcriptase inhibitors*
- •7. Pregnant or breast feeding
- •8. Anticipated transfer to another hospital which is not a trial site within 24 hours
- •9. Allergy to Brensocatib
- •10. Use of any investigational drug within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer. Co-enrolment with COVID-19 trials is allowed as per co-enrolment agreements and/or individual decision by the CI
- •11. Women of child-bearing potential must be willing to have pregnancy testing prior to trial entry.
- •*The Liverpool HIV checker (https://www.hiv-druginteractions.org/checker) should be used to check for any HIV drug interactions. Simvastatin could be used as a surrogate for Brensocatib as it metabolised similarly by CYP 3A4 pathway
- •Previous exclusion criteria as of 10/11/2020:
- •1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5x the upper limit of normal, result within 72 h of randomization (the result closest to randomization should be used if several results are available)
- •2. History of severe liver disease
- •3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30), result within 72 h of randomization (the result closest to randomization should be used if several results are available)
- •4. Absolute neutrophil count less than 1.0 x 10(9) cells/l within 72 h of randomization (the result closest to randomization should be used if several results are available)
- •5. Current treatment with Itraconazole, Ketoconazole, diltiazem, verapamil, phenytoin or rifampicin
- •6. HIV treatments - current treatment with protease/integrase inhibitors or non-nucleoside reverse transcriptase inhibitors*
- •7. Pregnant or breast feeding
- •8. Anticipated transfer to another hospital which is not a trial site within 24 hours
- •9. Allergy to brensocatib
- •10. Use of any investigational drug within 5 times the elimination half-life after the last trial dose or within 30 days, whichever is longer
- •*The Liverpool HIV checker (https://www.hiv-druginteractions.org/checker) should be used to check for any HIV drug interactions. Simvastatin could be used as a surrogate f
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