COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Brensocatib
Product Code: INS1007
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Brensocatib
CAS Number: 1802148-05-5
Current Sponsor code: INS1007
Other descriptive name:
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female • =16 years of age • SARS-CoV-2infection (clinically suspected+ or laboratory confirmed*). • Admitted to hospital as in-patient less than 96 hours prior to randomisation^ • Illness of any duration, and at least one of the following: o Radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (CT) scan) OR o Evidence of rales/crackles on physical examination OR o Peripheral capillary oxygen saturation (SpO2) =94% on room air prior to randomization OR o Requiring supplemental oxygen. OR o Lymphocyte count =65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: • 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). • History of severe liver disease • 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) • 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) • Current treatment with Itraconazole, Ketoconazole, diltiazem, verapamil, phenytoin or rifampicin • HIV treatments - current treatment with protease/integrase inhibitors or non-nucleoside reverse transcriptase inhibitors* • Pregnant or breast feeding. • Anticipated transfer to another hospital which is not a trial site within 24 hours. • Allergy to Brensocatib • 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the study is to evaluate the clinical efficacy of Brensocatib compared to placebo on top of standard care in adult patients hospitalized with COVID-19;Secondary Objective: Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm Quality of life;Primary end point(s): Clinical status on 7-point ordinal scale: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitation on activities; 3. Hospitalised, not requiring supplemental oxygen; 4. Hospitalised, requiring supplemental oxygen; 5. Hospitalised, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalised, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation) 7. Death. ;Timepoint(s) of evaluation of this end point: Up to day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical Severity Time to an improvement of one category from admission using 7-point ordinal scale. Daily whilst hospitalised Participant clinical status on 7-point ordinal scale Days 3, 5, 8, 11, 15 and 29. Mean change in the 7-point ordinal scale Baseline to days 3, 5, 8, 11, 15 and 29. National Early Warning Score (NEWS): Time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first. Daily whilst in hospital. Change from baseline Days 8, 15, 29 Oxygenation: Oxygen free days 1-29 days Incidence and duration of new oxygen use during the trial 1-29 days Mechanical Ventilation: Ventilator free days 1-29 days Incidence and duration of new mechanical ventilation use during the trial. 1-29 days Hospitalisation: Duration of hospitalisation (days). Date of admission and discharge Mortality: 28-day mortality Date of death Cumulative incidence of serious Adverse events (SAEs) 1-29 days Discontinuation or temporary suspension of treatment 1-29 days Changes in white cell count, haemoglobin, platelets, creatinine, total bilirubin, ALT, and AST over time (hospitalised participants only) Days 0/1, 3, 5, 8, 11, 15, 29 Adverse events of special interest- hyperkeratosis, infections and dental complications 1-29 days EQ-5D-5L administered via telephone (if at home) or in person if still in hospital Day 29 ;Timepoint(s) of evaluation of this end point: As above | — |
Countries
United Kingdom
Contacts
Public ContactJames Chalmers
University of Dundee
Outcome results
None listed