Status:
COMPLETED
STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19
Lead Sponsor:
University of Dundee
Collaborating Sponsors:
NHS Tayside
Insmed Incorporated
Conditions:
Covid19
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 and no t...
Detailed Description
BACKGROUND COVID-19 is a respiratory disease caused by a novel coronavirus severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and causes substantial morbidity and mortality.This clinical tri...
Eligibility Criteria
Inclusion
- 1. Inclusion criteria
- • Male or female
- ≥16 years of age
- SARS-CoV-2 infection (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:
- Radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (CT) scan) OR
- Evidence of rales/crackles on physical examination OR
- Peripheral capillary oxygen saturation (SpO2) ≤94% on room air prior to randomization OR
- Requiring supplemental oxygen. OR
- Lymphocyte count \<1 x 109 cells per litre (L)
- Participant (or legally authorized representative) provides written informed consent
- Able to take oral medication
- 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 COVID-19 symptoms whilst an in-patient, randomisation may occur up to 96 hours from onset of symptoms.
Exclusion
- 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. estimated Glomerular Filtration Rate \< 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 treatments with potent Cyp3A4 inducers/inhibitors (e.g 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 Chief Investigator.
- 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.
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Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT04817332
Start Date
June 5 2020
End Date
February 28 2021
Last Update
August 22 2023
Active Locations (16)
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1
NHS Grampian
Aberdeen, United Kingdom
2
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
3
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
4
Cardiff & Vale University Health Board
Cardiff, United Kingdom