Trial · NCT04455815

A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1)

NCT04455815, Phase 2, Terminated, Cancer Research UK; results first posted 2023-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1). Trials, record NCT04455815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04455815

On this page

Trial

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

Title: A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1)
NCT number: NCT04455815
Status: Terminated
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: Cancer Research UK
Conditions: COVID-19 Infection
Interventions: Camostat
First posted: 2020-07-02
Last updated: 2023-12-11
Other registries' IDs: eudract:2020-002110-41
Results first posted: 2023-12-11

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Number of Camostat Related AEs and SAEs.	Days 1 - 28	Number of AEs and SAEs assessed as related to camostat by the Investigator.
Primary	Number of AEs by Severity Grade	Days 1 - 28	Number of AEs by Severity Grade (mild, moderate, severe)
Secondary	PK Parameter Maximum Concentration (Cmax) of 4-(4-Guanidinobenzoyloxy)Phenylacetic Acid (GBPA).	Days 7 and 14	Maximum concentration (Cmax) of GBPA as assessed by population estimates from population PK analysis.
Secondary	PK Parameter Time to Maximum Concentration (Tmax) of GBPA	Days 7 and 14	Time to maximum concentration (Tmax) of GBPA, as assessed by population estimates from population PK analysis.
Secondary	PK Parameter Area Under the Curve (AUC) of GBPA	Days 7 and 14	Area under the curve (AUC) of GBPA, as assessed by population estimates from population PK analysis.
Secondary	PK Parameter to Confirm Half-life (T1/2) of GBPA	Days 1 - 28	Half-life (T1/2) of GBPA as assessed by population estimates from population PK analysis
Secondary	Number of Community Patients Admitted to Hospital Due to COVID-19	Days 1 - 28	Number of patients who were recruited in community healthcare settings who were subsequently admitted to hospital due to COVID-19.
Secondary	Number of Oxygen Free Days	Days 1 - 28	Number of days from Day 1 that each patient did not supplementary oxygen (median and range).
Secondary	Number of Ventilator - Free Days	Days 1 - 28	Number of days from Day 1 that each patient did not require ventilation (median and range).
Secondary	Time to Worst Point on the Scale or Deterioration of Two Points or More (From Randomisation) on 9 Point Category Ordinal Scale Ranging From '0 - Uninfected, no Clinical or Virological Evidence of Infection' to '8 - Death'	Days 1 - 28	Median time and range to worst point on the scale or deterioration of two points or more (from randomisation) on 9 point category ordinal scale. The scale was described in the protocol as follows: '0 - Uninfected, no clinical or virological evidence of infection, 1 - Ambulatory, no limitation of activities, 2 - Ambulatory, limitation of activities, 3 - Hospitalised - mild disease, no oxygen therapy, 4 - Hospitalised - mild disease, oxygen by mask or nasal prongs, 5 - Hospitalised - severe disease, non-invasive, ventilation or high-flow oxygen, 6 - Hospitalised - severe disease, intubation and mechanical ventilation, 7 - Hospitalised - severe disease, ventilation and additional organ support - vasopressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO), 8 - Death'

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Camostat Related AEs and SAEs.	Days 1 - 28	All enrolled patients who received at least one dose of camostat. As only participants in the Camostat Arm received camostat, this outcome measure is reported in the Camostat Arm only.	Adverse Events	NUMBER
PRIMARY	Number of AEs by Severity Grade	Days 1 - 28	All enrolled patients who received at least one dose of camostat (or complete Day 1 of the control arm).	Adverse Events	NUMBER
SECONDARY	PK Parameter Maximum Concentration (Cmax) of 4-(4-Guanidinobenzoyloxy)Phenylacetic Acid (GBPA).	Days 7 and 14	Analysis was not completed because no samples were collected for this analysis.
SECONDARY	PK Parameter Time to Maximum Concentration (Tmax) of GBPA	Days 7 and 14	Analysis was not completed because no samples were collected for this analysis
SECONDARY	PK Parameter Area Under the Curve (AUC) of GBPA	Days 7 and 14	Analysis was not completed because no samples were collected for this analysis
SECONDARY	PK Parameter to Confirm Half-life (T1/2) of GBPA	Days 1 - 28	Analysis was not completed because no samples were collected for this analysis
SECONDARY	Number of Community Patients Admitted to Hospital Due to COVID-19	Days 1 - 28	Treatment arm patients who received camostat for a minimum of five days, and control arm patients who completed up to Day 14 or came off trial at an earlier timepoint due to an endpoint (e.g. hospitalisation).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Oxygen Free Days	Days 1 - 28	Treatment arm patients who received camostat for a minimum of five days, and control arm patients who completed up to Day 14 or came off trial at an earlier timepoint due to an endpoint (e.g. hospitalisation).	Days	MEDIAN
SECONDARY	Number of Ventilator - Free Days	Days 1 - 28	Treatment arm patients who received camostat for a minimum of five days, and control arm patients who completed up to Day 14 or came off trial at an earlier timepoint due to an endpoint (e.g. hospitalisation).	Days	MEDIAN
SECONDARY	Time to Worst Point on the Scale or Deterioration of Two Points or More (From Randomisation) on 9 Point Category Ordinal Scale Ranging From '0 - Uninfected, no Clinical or Virological Evidence of Infection' to '8 - Death'	Days 1 - 28	Treatment arm patients who received camostat for a minimum of five days, and control arm patients who completed up to Day 14 or came off trial at an earlier timepoint due to an endpoint (e.g. hospitalisation).	Days	MEDIAN

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Category	Value	Units
Number of Camostat Related AEs and SAEs.	Camostat	Total AEs related to Camostat	11	Adverse Events
Number of Camostat Related AEs and SAEs.	Camostat	Total SAEs related to Camostat	0	Adverse Events
Number of AEs by Severity Grade	Camostat	Total Mild AEs	25	Adverse Events
Number of AEs by Severity Grade	Control Arm	Total Mild AEs	25	Adverse Events
Number of AEs by Severity Grade	Camostat	Total Moderate AEs	10	Adverse Events
Number of AEs by Severity Grade	Control Arm	Total Moderate AEs	5	Adverse Events
Number of AEs by Severity Grade	Camostat	Total Severe AEs	2	Adverse Events
Number of AEs by Severity Grade	Control Arm	Total Severe AEs	2	Adverse Events
Number of AEs by Severity Grade	Camostat	Total Mild AEs related to Camostat	5	Adverse Events
Number of AEs by Severity Grade	Control Arm	Total Mild AEs related to Camostat	NA	Adverse Events

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Randomisation Phase	STARTED	Camostat	16
Randomisation Phase	STARTED	Control Arm	18
Randomisation Phase	COMPLETED	Camostat	15
Randomisation Phase	COMPLETED	Control Arm	18
Randomisation Phase	NOT COMPLETED	Camostat	1
Randomisation Phase	NOT COMPLETED	Control Arm	0
Treatment Phase	STARTED	Camostat	15
Treatment Phase	STARTED	Control Arm	18
Treatment Phase	COMPLETED	Camostat	13
Treatment Phase	COMPLETED	Control Arm	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events76

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	Alanine aminotransferase increased	Investigations	Camostat	1	16	1
other	Alanine aminotransferase increased	Investigations	Control Arm	2	18	2
other	Aspartate aminotransferase increased	Investigations	Camostat	1	16	1
other	Aspartate aminotransferase increased	Investigations	Control Arm	1	18	1
other	Blood alkaline phosphatase increased	Investigations	Camostat	0	16	0
other	Blood alkaline phosphatase increased	Investigations	Control Arm	1	18	1
other	Blood bilirubin increased	Investigations	Camostat	1	16	1
other	Blood bilirubin increased	Investigations	Control Arm	0	18	0
other	COVID-19 pneumonia	Infections and infestations	Camostat	1	16	1
other	COVID-19 pneumonia	Infections and infestations	Control Arm	1	18	1

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Camostat	0	16
Total, all-cause mortality	Control Arm	0	18
Total, other adverse events	Camostat	14	16
Total, other adverse events	Control Arm	13	18
Total, serious adverse events	Camostat	4	16
Total, serious adverse events	Control Arm	1	18

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34412682	BACKGROUND

Source PubMed

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 comparisons3

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

Comparison	Source
Camostat vs Control Arm: Number of Community Patients Admitted to Hospital Due to COVID-19	Trial comparisons
Camostat vs Control Arm: deaths from any cause	Trial comparisons
Camostat vs Control Arm: 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.

For software

Read this trial from software.

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

GET https://conductscience.org/api/trials/v1/NCT04455815

GET https://conductscience.org/api/trials/v1/NCT04455815/results?page=2

API reference For AI assistants