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

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 3

Conditions

Covid19

Treatments

Drug: Camostat Mesylate

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04608266

APHP200702

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)