COVID-19 trials registries data warehouse

http://www.isrctn.com/ISRCTN30564012

Margaret Band

m.band@dundee.ac.uk

2020-05-20

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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 or verapamil 6. Pregnant or breast feeding 7. Anticipated transfer to another hospital which is not a trial site within 24 hours 8. Allergy to brensocatib 9. Use of any investigational drug within 5 times the elimination half-life after the last trial dose or within 30 days, whichever is longer

2

University of Dundee

16

100

United Kingdom

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

300

Participant clinical status (on a 7-point ordinal scale); up to day 29

Phase 3

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 232, "treatment_name": "Brensocatib", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}]