Scientific committee decision due SARS-CoV2 pandemic evolution with a decrease in inclusions and widespread distribution of vaccines

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.

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)