Back to resultsCAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID)
Primary Purpose
Covid19
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Camostat Mesylate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
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)
Sites / Locations
- Centre Hospitalier Victor Dupouy
- AP-HP Hôpital Henri Mondor
- Centre Hospitalier Sud Ile de France - Melun
- AP-HP Hôpital Bichat
- APHP - Saint Louis
- Centre de Santé Richerand
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Camostat mesylate
Placebo
Arm Description
Camostat mesylate, oral administration 600mg/day
Placebo tablets, oral administration
Outcomes
Primary Outcome Measures
Hospitalization for COVID-19 deterioration or death without hospitalization
Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization
Secondary Outcome Measures
Adverse events
Number of patients with at least one adverse event
Serious adverse events
Number of patients with at least one serious adverse event
Investigational medication discontinuation
Number of patients who discontinued the investigational medication
Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee
Proportion of patients hospitalized for COVID-19 deterioration (reviewed by independent adjudication comitter) or who died without hospitalization
Clinical improvement using the Word Health Organization (WHO) COVID-19 scale
WHO clinical scale: Uninfected - No clinical or virological evidence of infection: 0; Ambulatory - No limitation of activities: 1; Ambulatory - limitation of activities: 2; Hospitalized - no oxygen therapy: 3; Hospitalized - oxygen by mask or nasal prongs: 4; Hospitalized; oxygen by non invasive ventilation or High flow: 5; Intubation and Mechanical ventilation: 6; Mechanical ventilation + additional organ support (pressors, Renal replacement therapy, ECMO):7; Dead: 8
Need for intensive care
Proportion of patients admitted to an intensive care unit
Duration of hospitalization
Number of days alive without hospitalization up to day 21
Need for invasive mechanical ventilation for severe COVID-19
Proportion of patients with initiation of invasive mechanical ventilation
Need for oxygen therapy for COVID-19
Proportion of patients with initiation of oxygen therapy
Overall survival
Proportion of patients alive at day 90
Duration of symptoms
Number of days alive without symptoms at day 21
SARS-CoV-2 virological assessment
By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) on nasal swab and droplet quantification of SARS-CoV2 ribonucleic acid-emia (RNAemia)
SARS-CoV-2 serological assessment
SARS-CoV2 antibodies quantification in blood
Peripheral blood lymphocyte phenotyping
Peripheral blood lymphocyte phenotyping with telomere length measurement
Acute kidney failure
Acute kidney failure defined as at least serum creatinine increase of 0.3mg/dl or 1.5-1.9 times baseline and/or oliguria < 0.5ml/kg/h
Renal function
estimated glomerular filtration rate
Concentration of urea in blood
Uricemia in mmol/L or mg/dL
Concentration of potassium in blood
Kaliemia in mmol/L
Liver function
Liver transaminases dosage on blood sample
Liver function (2)
Gamma-glutamyl transferase (gamma-GT) dosage on blood sample
Full Information
NCT ID
NCT04608266
First Posted
October 28, 2020
Last Updated
January 27, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04608266
Brief Title
CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients
Acronym
CAMOVID
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Scientific committee decision due SARS-CoV2 pandemic evolution with a decrease in inclusions and widespread distribution of vaccines
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Camostat mesylate
Arm Type
Experimental
Arm Description
Camostat mesylate, oral administration 600mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets, oral administration
Intervention Type
Drug
Intervention Name(s)
Camostat Mesylate
Intervention Description
Camostat mesylate, oral administration 600mg/day (2 x 100mg tablets every 8 hours) for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets, oral administration 2 tablets every 8 hours for 14 days
Primary Outcome Measure Information:
Title
Hospitalization for COVID-19 deterioration or death without hospitalization
Description
Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of patients with at least one adverse event
Time Frame
Day 21
Title
Serious adverse events
Description
Number of patients with at least one serious adverse event
Time Frame
Day 21
Title
Investigational medication discontinuation
Description
Number of patients who discontinued the investigational medication
Time Frame
Day 21
Title
Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee
Description
Proportion of patients hospitalized for COVID-19 deterioration (reviewed by independent adjudication comitter) or who died without hospitalization
Time Frame
Day 21
Title
Clinical improvement using the Word Health Organization (WHO) COVID-19 scale
Description
WHO clinical scale: Uninfected - No clinical or virological evidence of infection: 0; Ambulatory - No limitation of activities: 1; Ambulatory - limitation of activities: 2; Hospitalized - no oxygen therapy: 3; Hospitalized - oxygen by mask or nasal prongs: 4; Hospitalized; oxygen by non invasive ventilation or High flow: 5; Intubation and Mechanical ventilation: 6; Mechanical ventilation + additional organ support (pressors, Renal replacement therapy, ECMO):7; Dead: 8
Time Frame
Day 7, 14, 21
Title
Need for intensive care
Description
Proportion of patients admitted to an intensive care unit
Time Frame
Day 21
Title
Duration of hospitalization
Description
Number of days alive without hospitalization up to day 21
Time Frame
Day 21
Title
Need for invasive mechanical ventilation for severe COVID-19
Description
Proportion of patients with initiation of invasive mechanical ventilation
Time Frame
Day 21
Title
Need for oxygen therapy for COVID-19
Description
Proportion of patients with initiation of oxygen therapy
Time Frame
Day 21
Title
Overall survival
Description
Proportion of patients alive at day 90
Time Frame
Day 90
Title
Duration of symptoms
Description
Number of days alive without symptoms at day 21
Time Frame
Day 21
Title
SARS-CoV-2 virological assessment
Description
By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) on nasal swab and droplet quantification of SARS-CoV2 ribonucleic acid-emia (RNAemia)
Time Frame
Day 7, 14, 21
Title
SARS-CoV-2 serological assessment
Description
SARS-CoV2 antibodies quantification in blood
Time Frame
Day 7, 14, 21 and 90
Title
Peripheral blood lymphocyte phenotyping
Description
Peripheral blood lymphocyte phenotyping with telomere length measurement
Time Frame
Day 1, 14, 90
Title
Acute kidney failure
Description
Acute kidney failure defined as at least serum creatinine increase of 0.3mg/dl or 1.5-1.9 times baseline and/or oliguria < 0.5ml/kg/h
Time Frame
Day 21
Title
Renal function
Description
estimated glomerular filtration rate
Time Frame
Day 7, 14 and 21
Title
Concentration of urea in blood
Description
Uricemia in mmol/L or mg/dL
Time Frame
Day 7, 14 and 21
Title
Concentration of potassium in blood
Description
Kaliemia in mmol/L
Time Frame
Day 7, 14 and 21
Title
Liver function
Description
Liver transaminases dosage on blood sample
Time Frame
Day 7, 14 and 21
Title
Liver function (2)
Description
Gamma-glutamyl transferase (gamma-GT) dosage on blood sample
Time Frame
Day 7, 14 and 21
Other Pre-specified Outcome Measures:
Title
Biobanking for biomarker assessment
Description
Biobanking of blood samples for predictive biomarker assessment
Time Frame
Day 1, 7, 14, 21, 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
Country
France
Facility Name
AP-HP Hôpital Henri Mondor
City
Créteil
Country
France
Facility Name
Centre Hospitalier Sud Ile de France - Melun
City
Melun
Country
France
Facility Name
AP-HP Hôpital Bichat
City
Paris
Country
France
Facility Name
APHP - Saint Louis
City
Paris
Country
France
Facility Name
Centre de Santé Richerand
City
Paris
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients
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