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

NCT ID: NCT04608266

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2021-12-02

Brief 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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Camostat mesylate

Camostat mesylate, oral administration 600mg/day

Group Type: EXPERIMENTAL

Camostat Mesylate

Intervention Type: DRUG

Camostat mesylate, oral administration 600mg/day (2 x 100mg tablets every 8 hours) for 14 days

Placebo

Placebo tablets, oral administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets, oral administration 2 tablets every 8 hours for 14 days

Interventions

Camostat Mesylate

Camostat mesylate, oral administration 600mg/day (2 x 100mg tablets every 8 hours) for 14 days

Intervention Type: DRUG

Placebo

Placebo tablets, oral administration 2 tablets every 8 hours for 14 days

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

France

Other Identifiers

APHP200702

Identifier Type: -

Identifier Source: org_study_id