COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04608266

David Boutboul, MD PhD

david.boutboul@aphp.fr

2020-10-29

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - patients ≥ 18 years old - patients with an increased risk of severe covid-19 belonging to one or more of the following groups : - age ≥ 50 years - body mass index ≥ 30 kg/m² - diabetes - hypertension - chronic renal failure (egfr <60 ml/min) - chronic heart disease - asthma/chronic obstructive pumonary disease/cystic fibrosis - chronic liver disease - chronic neurological disease - solid organ transplant - bone marrow transplant - sickle cell anemia/ major thalassemias - active or currently treated or <1 year diagnosed cancer - active or currently treated or <1 year diagnosed malignant blood disease - immunosuppressive treatment observed for more than 1 month - laboratory confirmed sars-cov2 infection with mild covid-19, fulfilling all the following criteria: - positive sars-cov-2 rt-pcr nasal swab samples and - clinical symptoms and signs consistent with sars-cov2 infection including but not limited to, fever, upper respiratory tract infection signs, digestive signs, muscle pain, anosmia, dysgueusia…(1) - informed consent to participate to the trial - patients must be able and willing to comply with study visits and procedures

- initial need for hospitalization for covid-19 management - pregnancy and breastfeeding - participation to another interventional drug trial - subject protected by law under guardianship or curatorship - absence of health insurance - known hypersensitivity to camostat mesylate - known person sharing the same household already included in the study - participation to another covid-19 ambulatory interventional study - patients having completed a full sars-cov2 vaccine immunization procedure less than 4 weeks prior to covid-19 diagnosis (last vaccine injection performed less than 4 weeks prior to covid-19 diagnosis)

2

Assistance Publique - Hôpitaux de Paris

18

100

France

Mild disease at enrollment

1: Mild disease at enrollment

70

Hospitalization for COVID-19 deterioration or death without hospitalization

None

Phase 3

[{"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"}]