COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04625114

Marie-Angélique De Scheerder

marie-angelique.descheerder@uzgent.be

2020-11-12

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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).

None

2

University Hospital, Ghent

18

100

Belgium

Mild disease at enrollment

1: Mild disease at enrollment

150

Efficacy in terms of viral load or surrogate

None

Phase 2

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