The overall objective of the study is to determine the therapeutic effect and tolerance of Camostat mesylate, compared to placebo in adult patients with ambulatory COVID-19 disease, presenting with risk factors of severe COVID-19. Camostat mesylate is a serine protease TMPRSS2 (Transmembrane Serine Protease 2) inhibitor which has been successfully and safely used to treat pancreatitis-associated pain and post-operative reflux oesophagitis in Japan. More recently, it has been shown to inhibit SARS-CoV-2 viral entry and reduce infection of human primary pneumocytes and lung cell lines. Camostat mesylate or placebo will be administered to consenting adult patients with virologically confirmed COVID-19, not requiring initial hospitalization. All patients will receive standard of care along with randomized treatments. Outcomes of included patients will be compared between the 2 groups.
Drug: Camostat Mesylate
Camostat mesylate, oral administration 600mg/day (2 x 100mg tablets every 8 hours) for 14 days
Drug: Placebo
Placebo tablets, oral administration 2 tablets every 8 hours for 14 days
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
Exclusion Criteria:
- 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)
Centre Hospitalier Victor Dupouy
Argenteuil, France
AP-HP Hôpital Henri Mondor
Créteil, France
Centre Hospitalier Sud Ile de France - Melun
Melun, France
AP-HP Hôpital Bichat
Paris, France
APHP - Saint Louis
Paris, France
Centre de Santé Richerand
Paris, France