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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608266
Recruitment Status : Terminated (Scientific committee decision due SARS-CoV2 pandemic evolution with a decrease in inclusions and widespread distribution of vaccines)
First Posted : October 29, 2020
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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
Covid19 Drug: Camostat Mesylate Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 3, 2020
Actual Primary Completion Date : September 27, 2021
Actual Study Completion Date : December 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Hospitalization for COVID-19 deterioration or death without hospitalization [ Time Frame: Day 21 ]
    Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Day 21 ]
    Number of patients with at least one adverse event

  2. Serious adverse events [ Time Frame: Day 21 ]
    Number of patients with at least one serious adverse event

  3. Investigational medication discontinuation [ Time Frame: Day 21 ]
    Number of patients who discontinued the investigational medication

  4. Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee [ Time Frame: Day 21 ]
    Proportion of patients hospitalized for COVID-19 deterioration (reviewed by independent adjudication comitter) or who died without hospitalization

  5. Clinical improvement using the Word Health Organization (WHO) COVID-19 scale [ Time Frame: 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

  6. Need for intensive care [ Time Frame: Day 21 ]
    Proportion of patients admitted to an intensive care unit

  7. Duration of hospitalization [ Time Frame: Day 21 ]
    Number of days alive without hospitalization up to day 21

  8. Need for invasive mechanical ventilation for severe COVID-19 [ Time Frame: Day 21 ]
    Proportion of patients with initiation of invasive mechanical ventilation

  9. Need for oxygen therapy for COVID-19 [ Time Frame: Day 21 ]
    Proportion of patients with initiation of oxygen therapy

  10. Overall survival [ Time Frame: Day 90 ]
    Proportion of patients alive at day 90

  11. Duration of symptoms [ Time Frame: Day 21 ]
    Number of days alive without symptoms at day 21

  12. SARS-CoV-2 virological assessment [ Time Frame: 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)

  13. SARS-CoV-2 serological assessment [ Time Frame: Day 7, 14, 21 and 90 ]
    SARS-CoV2 antibodies quantification in blood

  14. Peripheral blood lymphocyte phenotyping [ Time Frame: Day 1, 14, 90 ]
    Peripheral blood lymphocyte phenotyping with telomere length measurement

  15. Acute kidney failure [ Time Frame: 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

  16. Renal function [ Time Frame: Day 7, 14 and 21 ]
    estimated glomerular filtration rate

  17. Concentration of urea in blood [ Time Frame: Day 7, 14 and 21 ]
    Uricemia in mmol/L or mg/dL

  18. Concentration of potassium in blood [ Time Frame: Day 7, 14 and 21 ]
    Kaliemia in mmol/L

  19. Liver function [ Time Frame: Day 7, 14 and 21 ]
    Liver transaminases dosage on blood sample

  20. Liver function (2) [ Time Frame: Day 7, 14 and 21 ]
    Gamma-glutamyl transferase (gamma-GT) dosage on blood sample


Other Outcome Measures:
  1. Biobanking for biomarker assessment [ Time Frame: Day 1, 7, 14, 21, 90 ]
    Biobanking of blood samples for predictive biomarker assessment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608266


Locations
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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, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04608266    
Other Study ID Numbers: APHP200702
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Camostat
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors