COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003475-18/BE

Ghent University Hospital - HIRUZ

hiruz.ctu@uzgent.be

2020-09-16

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

- 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 at Ghent University Hospital, 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 - 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

- 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 flow chart used at the emergency department - 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 or serum (if an early pregnancy cannot be excluded) 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)

2

Ghent University Hospital

18

100

Belgium

Mild disease at enrollment

1: Mild disease at enrollment

150

The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) log10 viral load. Descriptive endpoints are to assess the safety and compliance of the drug in ambulatory setting.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": null, "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]