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

NCT04455815 | Terminated Phase 2 Results

• 2 other identifiers: CRUKD/20/0022020-002110-41
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 9

Brief Summary

This is a phase II randomised, multicentre, prospective, open label clinical trial. The trial aims to recruit patients who test positive for COVID-19 who have mild symptoms and therefore can treat their symptoms in the community. Patients who test positive for COVID-19 at hospital may also be able to participate.

Conditions

COVID-19 Infection

Keywords

COVID-19; Coronavirus Infections; Respiratory Tract Infections; Pneumonia, Viral; Virus Diseases; Camostat; Protease Inhibitors; Enzyme Inhibitors; Serine Proteinase Inhibitors

Outcome Measures

Primary Outcomes (2)

• Number of Camostat Related AEs and SAEs.

  Number of AEs and SAEs assessed as related to camostat by the Investigator.

  Days 1 - 28

• Number of AEs by Severity Grade

  Number of AEs by Severity Grade (mild, moderate, severe)

  Days 1 - 28

Secondary Outcomes (8)

• PK Parameter Maximum Concentration (Cmax) of 4-(4-Guanidinobenzoyloxy)Phenylacetic Acid (GBPA).

  Days 7 and 14

• PK Parameter Time to Maximum Concentration (Tmax) of GBPA

  Days 7 and 14

• PK Parameter Area Under the Curve (AUC) of GBPA

  Days 7 and 14

• PK Parameter to Confirm Half-life (T1/2) of GBPA

  Days 1 - 28

• Number of Community Patients Admitted to Hospital Due to COVID-19

  Days 1 - 28

Study Arms (2)

Camostat

EXPERIMENTAL

Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.

Drug: Camostat

Control arm

NO INTERVENTION

Patient to receive best supportive care.

Interventions

Camostat DRUG

Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.

Also known as: Camostat mesylate, Camostat mesilate

Camostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient willing and able to give informed consent
• Adults, 18 years of age and above
• Symptomatic COVID-19 infection
• Evidence of current COVID-19 infection from a validated assay

You may not qualify if:

• The patient may not enter the trial if ANY of the following apply:
• Significant electrolyte disturbance (e.g. hyperkalaemia, potassium \> site specific upper limit of normal)
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or Alkaline Phosphatase (ALP) ≥ 2.5 x ULN
• Any condition that, in the Investigator's opinion, would not make the patient a good candidate for the clinical trial or would prevent adequate compliance with trial therapy e.g. mild cognitive impairment (unable to follow instructions for self-assessment readings as assessed by the Investigator).
• Patients on long term supplementary oxygen requirement (patients for whom hospital admission would not be considered e.g. care plan in the community is in place, are not excluded)
• Known hypersensitivity to camostat
• Platelet count \<100 x 10\^9/L
• Co-enrolment with a Clinical Trial of an Investigational Medicinal Product (CTIMP) will not be permitted. Co-enrolment with a clinical investigation of a Medical Device or a non-interventional clinical study will be considered on a study-by-study basis and in discussion with the relevant Chief Investigators and Sponsors and industrial collaborators.
• Co-enrolment involving non-interventional research (including questionnaire or tissue only studies) will be allowed provided this is not expected to affect the outcomes of both studies or place undue burden upon participants and their families.
• Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who are of child bearing potential and have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method \[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\]) or agree to sexual abstinence\*, effective from the first administration of camostat, throughout the trial and for 28 days afterwards are considered eligible.
• (\*Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \[e.g. calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
• Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception \[condom plus spermicide\] or to sexual abstinence\* effective from the first administration of camostat, throughout the trial and for 28 days afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
• (\*Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \[e.g. calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
• Significant cardiovascular disease (as assessed via the participant's medical record and history) as defined by:
• History of congestive heart failure requiring therapy (New York Heart Association \[NYHA\] III or IV)

Sponsors & Collaborators

• Cancer Research UK: lead
• Latus Therapeutics: collaborator

Study Sites (9)

Chawton Park Surgery

Alton, United Kingdom

Location

The Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Church Avenue Medical Group

Harrogate, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Preston Lantern Centre

Preston, United Kingdom

Location

Clarence Medical Centre

Rhyl, United Kingdom

Location

Trafalgar Medical Practice

Southsea, United Kingdom

Location

Velindre Hospital

Wales, United Kingdom

Location

Eynsham Medical Centre

Witney, United Kingdom

Location

Related Publications (1)

• Halford S, Wan S, Dragoni I, Silvester J, Nazarov B, Anthony D, Anthony S, Ladds E, Norrie J, Dhaliwal K; CDD SPIKE-1 Project Team. SPIKE-1: A Randomised Phase II/III trial in a community setting, assessing use of camostat in reducing the clinical progression of COVID-19 by blocking SARS-CoV-2 Spike protein-initiated membrane fusion. Trials. 2021 Aug 19;22(1):550. doi: 10.1186/s13063-021-05461-9.

  PMID: 34412682 BACKGROUND

Related Links

• A lay summary of the trial on the Health Research Authority website

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Respiratory Tract Infections; Pneumonia, Viral; Virus Diseases

Interventions

camostat

Condition Hierarchy (Ancestors)

Pneumonia; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Regulatory Affairs Manager
• Organization: Cancer Research UK Centre for Drug Development

regulatory@cancer.org.uk

+44 203 4696878

Study Officials

• Kevin Dhaliwal, Professor

  The Royal Infirmary of Edinburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 2, 2020
• Study Start: September 23, 2020
• Primary Completion: November 29, 2021
• Study Completion: March 3, 2022
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: All requests made within 5 years from end-of-trial will be considered; requests made subsequently will be considered where possible.
• Access Criteria: When a request has been approved Cancer Research UK will provide access to the de-identified individual patient-level data and appropriate supporting information. A signed Data Sharing Agreement must be in place before accessing requested information. Requests should be submitted to drugdev@cancer.org.uk.

Locations

GB (9)