ISRCTN30564012
Completed
Phase 3
A randomised double-blind placebo-controlled trial of brensocatib (INS1007) in patients with severe COVID-19
niversity of Dundee0 sites406 target enrollmentMay 20, 2020
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Dundee
- Enrollment
- 406
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36075243/ (added 09/09/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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