Clinical trial NCT04608266: CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients
Official title: A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Hospitalization for COVID-19 deterioration or death without hospitalization
timeFrame: Day 21
Secondary outcomes:
measure: Adverse events
timeFrame: Day 21
measure: Serious adverse events
timeFrame: Day 21
measure: Investigational medication discontinuation
timeFrame: Day 21
measure: Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee
timeFrame: Day 21
measure: Clinical improvement using the Word Health Organization (WHO) COVID-19 scale
timeFrame: Day 7, 14, 21
measure: Need for intensive care
timeFrame: Day 21
measure: Duration of hospitalization
timeFrame: Day 21
measure: Need for invasive mechanical ventilation for severe COVID-19
timeFrame: Day 21
measure: Need for oxygen therapy for COVID-19
timeFrame: Day 21
measure: Overall survival
timeFrame: Day 90
measure: Duration of symptoms
timeFrame: Day 21
measure: SARS-CoV-2 virological assessment
timeFrame: Day 7, 14, 21
measure: SARS-CoV-2 serological assessment
timeFrame: Day 7, 14, 21 and 90
measure: Peripheral blood lymphocyte phenotyping
timeFrame: Day 1, 14, 90
measure: Acute kidney failure
timeFrame: Day 21
measure: Renal function
timeFrame: Day 7, 14 and 21
measure: Concentration of urea in blood
timeFrame: Day 7, 14 and 21
measure: Concentration of potassium in blood
timeFrame: Day 7, 14 and 21
measure: Liver function
timeFrame: Day 7, 14 and 21
measure: Liver function (2)
timeFrame: Day 7, 14 and 21
Other outcomes:
measure: Biobanking for biomarker assessment
timeFrame: Day 1, 7, 14, 21, 90
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Créteil
country: France
facility: AP-HP Hôpital Henri Mondor
city: Melun
country: France
facility: Centre Hospitalier Sud Ile de France - Melun
city: Paris
country: France
facility: AP-HP Hôpital Bichat
city: Paris
country: France
facility: APHP - Saint Louis
city: Paris
country: France
facility: Centre de Santé Richerand
Study officials:
References: