COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: FOIPAN ®
Product Name: Camostat mesilate
Product Code: Camostat
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CAMOSTAT MESILATE
CAS Number: 59721-29-8
Concentration unit: mg
Sponsors
Cancer Research UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient willing and able to give informed consent 2.Adults, 18 years of age and above who score moderate to very high risk according to COVID-age risk calculation (Appendix 4) 3.Typical symptoms of COVID-19 infection e.g.as per Public Health England guidance or equivalent organisations in the UK, Health Protection Scotland, Public Health Wales, Public Health Agency (Northern Ireland) 4.Plus evidence of current COVID-19 infection from a validated assay Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 273 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 116
Exclusion criteria
Exclusion criteria: 1.Significant electrolyte disturbance (e.g. hyperkalaemia, potassium >5.0 mmol/L). 2.Any condition that, in the Investigator's opinion, will prevent adequate compliance with trial therapy e.g. mild cognitive impairment (unable to follow instructions for self assessment readings as assessed by the Investigator). 3.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) 4.Known hypersensitivity to camostat 5.Platelet count <100 x 10^9/L 6.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. 7.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. 8.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.) 9.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.) 10.Significant cardiovascular disease (as assessed via the particpant’s medical record and history) as defined by: a. History of congestive heart failure requiring therapy (New York Heart Association (NYHA) III or IV) b. History of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry c. Presence of severe valvular heart disea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of camostat to prevent respiratory deterioration in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.;Secondary Objective: 1. To assess the ability of camostat to reduce the requirement for COVID-19 related hospital admission in patients with SARS-CoV-2 infection. 2. To evaluate the requirement for supplementary oxygen (non-invasive or mechanical invasive) in patients who have received camostat as treatment for SARS-CoV-2 infection. 3. To evaluate the requirement for ventilation in patients who have received camostat as treatment for SARS-CoV-2 infection. 4. To evaluate overall mortality. 5. To evaluate efficacy of camostat by effect on clinical improvement.;Primary end point(s): Hospital admission requiring supplemental oxygen;Timepoint(s) of evaluation of this end point: Days 1-28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Rate of COVID-19 related hospital admission in patients with SARS-CoV-2 infection 2. Supplementary oxygen-free days at 28 days (from randomisation) 3. Ventilator-free days at 28 days (from randomisation) 4. Mortality related to COVID-19, one year from randomisation 5. Time to worst point on the scale or deterioration of two points or more (from randomisation) on a 9-point category ordinal scale.;Timepoint(s) of evaluation of this end point: 1-3 and 5: Days 1-28 4: 1 year post randomisation | — |
Countries
United Kingdom
Contacts
Public ContactCentre for Drug Development
Cancer Research UK
Outcome results
None listed