CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Camostat

Criteria

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)