The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden

This is an interventional treatment trial for Covid19 focused on measuring antiviral Read More

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).