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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: Camostat Mesylate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Argenteuil, France
    • Centre Hospitalier Victor Dupouy
  • Créteil, France
    • AP-HP Hôpital Henri Mondor
  • Melun, France
    • Centre Hospitalier Sud Ile de France - Melun
  • Paris, France
    • APHP - Saint Louis
  • Paris, France
    • AP-HP Hôpital Bichat
  • Paris, France
    • Centre de Santé Richerand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biobanking for biomarker assessment	Biobanking of blood samples for predictive biomarker assessment	Day 1, 7, 14, 21, 90

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): December 2, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Camostat
• Other Study ID Numbers: APHP200702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No