COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04455815

Kevin Dhaliwal, Professor

Kev.Dhaliwal@ed.ac.uk

2020-07-02

Terminated

RCT

Randomized

Sequential assignment

Open label

multi-center

Treatment

inclusion criteria: 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

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) history of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry presence of severe valvular heart disease presence of a ventricular arrhythmia requiring treatment known allergic reactions to components of camostat e.g., lactose intolerance

2

Cancer Research UK

18

100

United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

34

Number of AEs by severity grade;Number of camostat related AEs and SAEs.

None

Phase 2

[{"arm_notes": "", "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]