CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Camostat mesylate Camostat mesylate, oral administration 600mg/day |
Drug: Camostat Mesylate
Camostat mesylate, oral administration 600mg/day (2 x 100mg tablets every 8 hours) for 14 days
|
| Placebo Comparator: Placebo Placebo tablets, oral administration |
Drug: Placebo
Placebo tablets, oral administration 2 tablets every 8 hours for 14 days
|
Outcome Measures
Primary Outcome Measures
- Hospitalization for COVID-19 deterioration or death without hospitalization [Day 21]
Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization
Secondary Outcome Measures
- Adverse events [Day 21]
Number of patients with at least one adverse event
- Serious adverse events [Day 21]
Number of patients with at least one serious adverse event
- Investigational medication discontinuation [Day 21]
Number of patients who discontinued the investigational medication
- Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee [Day 21]
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 [Day 7, 14, 21]
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 [Day 21]
Proportion of patients admitted to an intensive care unit
- Duration of hospitalization [Day 21]
Number of days alive without hospitalization up to day 21
- Need for invasive mechanical ventilation for severe COVID-19 [Day 21]
Proportion of patients with initiation of invasive mechanical ventilation
- Need for oxygen therapy for COVID-19 [Day 21]
Proportion of patients with initiation of oxygen therapy
- Overall survival [Day 90]
Proportion of patients alive at day 90
- Duration of symptoms [Day 21]
Number of days alive without symptoms at day 21
- SARS-CoV-2 virological assessment [Day 7, 14, 21]
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 [Day 7, 14, 21 and 90]
SARS-CoV2 antibodies quantification in blood
- Peripheral blood lymphocyte phenotyping [Day 1, 14, 90]
Peripheral blood lymphocyte phenotyping with telomere length measurement
- Acute kidney failure [Day 21]
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 [Day 7, 14 and 21]
estimated glomerular filtration rate
- Concentration of urea in blood [Day 7, 14 and 21]
Uricemia in mmol/L or mg/dL
- Concentration of potassium in blood [Day 7, 14 and 21]
Kaliemia in mmol/L
- Liver function [Day 7, 14 and 21]
Liver transaminases dosage on blood sample
- Liver function (2) [Day 7, 14 and 21]
Gamma-glutamyl transferase (gamma-GT) dosage on blood sample
Other Outcome Measures
- Biobanking for biomarker assessment [Day 1, 7, 14, 21, 90]
Biobanking of blood samples for predictive biomarker assessment
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Victor Dupouy | Argenteuil | France | ||
| 2 | AP-HP Hôpital Henri Mondor | Créteil | France | ||
| 3 | Centre Hospitalier Sud Ile de France - Melun | Melun | France | ||
| 4 | AP-HP Hôpital Bichat | Paris | France | ||
| 5 | APHP - Saint Louis | Paris | France | ||
| 6 | Centre de Santé Richerand | Paris | France |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP200702