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
  • End date
    Mar 14, 2022
  • participants needed
    596
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 14 April 2021

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.

Details
Condition COVID19
Treatment Placebo, Camostat Mesylate
Clinical Study IdentifierNCT04608266
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

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/m
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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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