Trial · NCT04817332

STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19

NCT04817332, Phase 3, Completed, University of Dundee; results first posted 2023-08-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19. Trials, record NCT04817332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04817332

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19
NCT number: NCT04817332
Status: Completed
Phases: Phase 3
Enrollment: 406 participants, actual
Lead sponsor: University of Dundee
Conditions: Covid19
Interventions: Brensocatib, Placebo
First posted: 2021-03-26
Last updated: 2023-08-22
Other registries' IDs: eudract:2020-001643-13
Results first posted: 2023-08-22

Source ClinicalTrials.gov

Registered outcomes30

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Comparison of Participant Clinical Status Between Treatment Arms	Up to 29 days	To determine the participant clinical status on a 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome: 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 Extracorporeal membrane oxygenation (ECMO) 7. Death.
Secondary	Improvement of One Category From Admission Using 7-point Ordinal Scale.	Day 29	Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitations 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 Extracorporeal membrane oxygenation (ECMO) 7. Death
Secondary	Participant Clinical Status on 7-point Ordinal Scale	Day 15	Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitations 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 Extracorporeal membrane oxygenation (ECMO) 7. Death
Secondary	Mean Change in the 7-point Ordinal Scale	Baseline to days 3, 5, 8, 11 and 29	Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitations 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 Extracorporeal membrane oxygenation (ECMO) 7. Death
Secondary	Number of Participants Discharged or to a National Early Warning Score (NEWS) of Equal or Less Than 2 and Maintained for 24 Hours, Whichever Occurs First.	Up to 29 days	Evaluation of the clinical efficacy of Brensocatib relative to standard care: National Early Warning Score (NEWS). NEWS is a system that scores 6 physiological parameters (respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, temperature) to give an aggerate score. Minimum score is 1, maximum score is 20.. Higher scores indicate worsening clinical outcomes.
Secondary	Change From Baseline of National Early Warning Score (NEWS).	Baseline to day 15	Evaluation of the clinical efficacy of Brensocatib relative to standard care: National Early Warning Score. NEWS is a system that scores 6 physiological parameters (respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, temperature) to give an aggerate score. Minimum score is 1, maximum score is 20.. Higher scores indicate worsening clinical outcomes.
Secondary	Number of Oxygen Therapy Free Days	1-29 days	Evaluation of the clinical efficacy of Brensocatib relative to standard care: oxygenation
Secondary	Incidence and Duration of New Oxygen Therapy Use During the Trial	0-29 days	Evaluation of the clinical efficacy of Brensocatib relative to standard care: oxygenation
Secondary	Number of Mechanical Ventilator Free Days	1-29 days	Evaluation of the clinical efficacy of Brensocatib relative to standard care: Mechanical ventilation
Secondary	Incidence and Duration of New Mechanical Ventilation Use During the Trial.	1-29 days	Evaluation of the clinical efficacy of Brensocatib relative to standard care: Mechanical ventilation

1 to 10 of 30Source ClinicalTrials.gov

See all 30 registered outcomes

Outcomes30

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Comparison of Participant Clinical Status Between Treatment Arms	Up to 29 days	Intention to treat	participants	NUMBER
SECONDARY	Improvement of One Category From Admission Using 7-point Ordinal Scale.	Day 29	ITT. Days to improvement was derived as~1. days from randomization to date of first follow-up day where there was an improvement in CSTAT~2. those who died before improvement were censored at date of death.~3. those who withdrew or were loss to follow-up before improvement, if their day 29 status was unknown, they were censored at the date of loss to follow-up/withdrawal~4. other participants were censored at day 29 from randomisation in study time if there were no improvement.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participant Clinical Status on 7-point Ordinal Scale	Day 15	ITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change in the 7-point Ordinal Scale	Baseline to days 3, 5, 8, 11 and 29	ITT	Units on WHO scale	MEAN
SECONDARY	Number of Participants Discharged or to a National Early Warning Score (NEWS) of Equal or Less Than 2 and Maintained for 24 Hours, Whichever Occurs First.	Up to 29 days	ITT. Those who died before being discharged or having a NEWS of ≤ 2 were censored at date of death. For those who withdrew or were loss to follow-up before being discharged or having a NEWS of ≤ 2, if their day 29 status was unknown, they were censored at the date of loss to follow-up/withdrawal. Other participants were censored at day 29 or 28 days from randomisation in study time if they were still in hospital and never had a NEWS of ≤ 2.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline of National Early Warning Score (NEWS).	Baseline to day 15		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Oxygen Therapy Free Days	1-29 days	ITT.	days	MEDIAN
SECONDARY	Incidence and Duration of New Oxygen Therapy Use During the Trial	0-29 days	For the duration of new oxygen use analysis, only participants who were hospitalised but not requiring supplemental oxygen (CSTAT = 3) at baseline were included	days	MEDIAN
SECONDARY	Number of Mechanical Ventilator Free Days	1-29 days	ITT	days	MEDIAN
SECONDARY	Incidence and Duration of New Mechanical Ventilation Use During the Trial.	1-29 days		days	MEDIAN

1 to 10 of 30Source ClinicalTrials.gov

See all 30 outcomes

Results by group130

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Comparison of Participant Clinical Status Between Treatment Arms	Brensocatib	Not hospitalized, no limitations on activities	28	participants
Comparison of Participant Clinical Status Between Treatment Arms	Placebo	Not hospitalized, no limitations on activities	40	participants
Comparison of Participant Clinical Status Between Treatment Arms	Brensocatib	Not hospitalized, limitations on activities	112	participants
Comparison of Participant Clinical Status Between Treatment Arms	Placebo	Not hospitalized, limitations on activities	129	participants
Comparison of Participant Clinical Status Between Treatment Arms	Brensocatib	Hospitalized, not requiring supplemental oxygen	7	participants
Comparison of Participant Clinical Status Between Treatment Arms	Placebo	Hospitalized, not requiring supplemental oxygen	11	participants
Comparison of Participant Clinical Status Between Treatment Arms	Brensocatib	Hospitalized, requiring supplemental oxygen	6	participants
Comparison of Participant Clinical Status Between Treatment Arms	Placebo	Hospitalized, requiring supplemental oxygen	1	participants
Comparison of Participant Clinical Status Between Treatment Arms	Brensocatib	Hospitalized, on non-invasive ventilation or high flow oxygen devices	0	participants
Comparison of Participant Clinical Status Between Treatment Arms	Placebo	Hospitalized, on non-invasive ventilation or high flow oxygen devices	1	participants

1 to 10 of 130Source ClinicalTrials.gov

See all 130 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brensocatib	192
Overall Study	STARTED	Placebo	214
Overall Study	COMPLETED	Brensocatib	187
Overall Study	COMPLETED	Placebo	211
Overall Study	NOT COMPLETED	Brensocatib	5
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events248

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Brensocatib	1	192	1
other	Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Placebo	0	214	0
other	Peripheral ischaemia	Vascular disorders	Brensocatib	1	192	1
other	Peripheral ischaemia	Vascular disorders	Placebo	0	214	0
other	Chest pain	General disorders	Brensocatib	0	192	0
other	Chest pain	General disorders	Placebo	4	214	4
other	Cold sweat	General disorders	Brensocatib	0	192	0
other	Cold sweat	General disorders	Placebo	1	214	1
other	Chest discomfort	General disorders	Brensocatib	2	192	2
other	Chest discomfort	General disorders	Placebo	0	214	0

1 to 10 of 248Source ClinicalTrials.gov

See all 248 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brensocatib	29	192
Total, all-cause mortality	Placebo	23	214
Total, other adverse events	Brensocatib	86	192
Total, other adverse events	Placebo	99	214
Total, serious adverse events	Brensocatib	40	192
Total, serious adverse events	Placebo	35	214

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Brensocatib vs Placebo: Improvement of One Category From Admission Using 7-point Ordinal Scale.	Trial comparisons
Brensocatib vs Placebo: Cumulative Incidence of Serious Adverse Events (SAEs)	Trial comparisons
Brensocatib vs Placebo: Discontinuation or Temporary Suspension of Treatment	Trial comparisons
Brensocatib vs Placebo: Number of Participants Discharged or to a National Early Warning Score (NEWS) of Equal or Less Than 2 and Maintained for 24 Hours, Whichever Occurs First.	Trial comparisons
Brensocatib vs Placebo: deaths from any cause	Trial comparisons
Brensocatib vs Placebo: 28-day Mortality	Trial comparisons
Brensocatib vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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