A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1)
Condition: COVID-19 Infection
MeSH terms: Infections; COVID-19
Intervention: Camostat
Intervention description: Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.
Intervention MeSH terms: Gabexate; Camostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Coronavirus Infections; Respiratory Tract Infections; Pneumonia, Viral; Virus Diseases; Camostat; Protease Inhibitors; Enzyme Inhibitors; Serine Proteinase Inhibitors

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient willing and able to give informed consent

          2. Adults, 18 years of age and above

          3. Symptomatic COVID-19 infection

          4. Evidence of current COVID-19 infection from a validated assay

        Exclusion Criteria:

        The patient may not enter the trial if ANY of the following apply:

          1. Significant electrolyte disturbance (e.g. hyperkalaemia, potassium > site specific
             upper limit of normal)

          2. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or Alkaline
             Phosphatase (ALP) ≥ 2.5 x ULN

          3. 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).

          4. 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)

          5. Known hypersensitivity to camostat

          6. Platelet count <100 x 10^9/L

          7. 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.

          8. 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.

          9. 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.)

         10. 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.)

         11. Significant cardiovascular disease (as assessed via the participant's medical record
             and history) as defined by:

               1. History of congestive heart failure requiring therapy (New York Heart Association
                  [NYHA] III or IV)

               2. History of unstable angina pectoris or myocardial infarction up to 6 months prior
                  to trial entry

               3. Presence of severe valvular heart disease

               4. Presence of a ventricular arrhythmia requiring treatment

        Known allergic reactions to components of camostat e.g., lactose intolerance