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

Covid19 Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04608266
• Other study ID #: APHP200702
• Status: Terminated
• Phase: Phase 3
• Start date: December 3, 2020
• Est. completion date: December 2, 2021

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: December 2, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biobanking for biomarker assessment	Biobanking of blood samples for predictive biomarker assessment	Day 1, 7, 14, 21, 90
Primary	Hospitalization for COVID-19 deterioration or death without hospitalization	Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization	Day 21
Secondary	Adverse events	Number of patients with at least one adverse event	Day 21
Secondary	Serious adverse events	Number of patients with at least one serious adverse event	Day 21
Secondary	Investigational medication discontinuation	Number of patients who discontinued the investigational medication	Day 21
Secondary	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	Day 21
Secondary	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	Day 7, 14, 21
Secondary	Need for intensive care	Proportion of patients admitted to an intensive care unit	Day 21
Secondary	Duration of hospitalization	Number of days alive without hospitalization up to day 21	Day 21
Secondary	Need for invasive mechanical ventilation for severe COVID-19	Proportion of patients with initiation of invasive mechanical ventilation	Day 21
Secondary	Need for oxygen therapy for COVID-19	Proportion of patients with initiation of oxygen therapy	Day 21
Secondary	Overall survival	Proportion of patients alive at day 90	Day 90
Secondary	Duration of symptoms	Number of days alive without symptoms at day 21	Day 21
Secondary	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)	Day 7, 14, 21
Secondary	SARS-CoV-2 serological assessment	SARS-CoV2 antibodies quantification in blood	Day 7, 14, 21 and 90
Secondary	Peripheral blood lymphocyte phenotyping	Peripheral blood lymphocyte phenotyping with telomere length measurement	Day 1, 14, 90
Secondary	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	Day 21
Secondary	Renal function	estimated glomerular filtration rate	Day 7, 14 and 21
Secondary	Concentration of urea in blood	Uricemia in mmol/L or mg/dL	Day 7, 14 and 21
Secondary	Concentration of potassium in blood	Kaliemia in mmol/L	Day 7, 14 and 21
Secondary	Liver function	Liver transaminases dosage on blood sample	Day 7, 14 and 21
Secondary	Liver function (2)	Gamma-glutamyl transferase (gamma-GT) dosage on blood sample	Day 7, 14 and 21