The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring antiviral
Eligibility Criteria
Inclusion Criteria
- Aged ≥18
- Willing to participate and fill out a daily symptom diary
- Willing to take the parameters such as blood oxygenation and temperature
- Willing to attend follow-up visits both by phone as at the clinic
- Capable of understanding the commitment in the trial
- Signed informed consent
- Signs and symptoms suggestive of COVID disease in absence of hospitalization criteria as defined by the flowchart used at the emergency department of our institution (appendix 4), present for maximum 5 days and confirmed by PCR.
- OR documented COVID-19 infection by PCR with CT value below the threshold of 30 in asymptomatic individuals.
- For women of childbearing potential*: they should be willing to use highly effective method of contraception during treatment and until the end of study defined as having a failure rate of less than 1% per year when used consistently and correctly.
Such methods include:
- combined (estrogen and progestogen containing) hormonal contraception
- associated with inhibition of ovulation: oral, intravaginal or transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable
- intrauterine device (IUD) and intrauterine hormone-releasing system ( IUS)
- bilateral tubal occlusion
- vasectomised partner
sexual abstinence
For men of reproductive potential**: condom should be used as contraception during treatment and until the end of study when having a partner of childbearing potential
a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
Exclusion Criteria
- Inability to make a decision to participate
- Pregnant or breast feeding
- Inability to take oral medication
- Inability to provide informed written consent
- Known hypersensitivity towards Camostat or other Serine protease inhibitors
- Any condition that, in the Investigator's opinion, prevents adequate compliance with study therapy.
- Any COVID infection at risk for hospitalisation as described in the emergency department flowchart (cfr appendix 4)
- With regard to exclusion of women of child-bearing potential, women who tell us they know they are pregnant are excluded. All women of child-bearing potential who test positive for pregnancy by urine test at first visit are excluded.
- Severe chronic pancreatitis requiring suction of gastric juice, fasting or abstention from drinking
- Postoperative reflux oesophagitis due to reflux or gastric juice
- Postoperative reflux oesophagitis (if improvement of symptoms is not observed).
Sites / Locations
- Ghent University Hospital, Algemene Inwendige ZiektenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Camostat
Placebo
camostat 100mg 3 tablets 3x/day D1->D5 (+ possible extension D6->D10)
Placebo 3 tablets 3x/day D1->D5 (+ possible extension D6->D10)