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Covid19Phase 3CAMOVIDNCT04608266

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

A Phase 3 study testing Camostat Mesylate in people with Covid19, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Camostat Mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
6 sitesFrance
Study dates
3 Dec 2020to 2 Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Centre Hospitalier Victor Dupouy

    Argenteuil

  • AP-HP Hôpital Henri Mondor

    Créteil

  • Centre Hospitalier Sud Ile de France - Melun

    Melun

  • AP-HP Hôpital Bichat

    Paris

  • APHP - Saint Louis

    Paris

  • Centre de Santé Richerand

    Paris

Other trials in France

About this study

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)

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.

Conditions
Covid19
Being tested
Camostat Mesylate, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camostat MesylateDrug

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

  • PlaceboDrug

    Placebo tablets, oral administration 2 tablets every 8 hours for 14 days

Study groups in NCT04608266
Study groupRoleWhat they receive
Camostat mesylateExperimentalCamostat mesylate, oral administration 600mg/day
Receives: Drug: Camostat Mesylate
PlaceboPlacebo comparatorPlacebo tablets, oral administration
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization for COVID-19 deterioration or death without hospitalization

    Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization

    Measured: Day 21

Secondary outcomes (20)

  1. Adverse events

    Number of patients with at least one adverse event

    Measured: Day 21

  2. Serious adverse events

    Number of patients with at least one serious adverse event

    Measured: Day 21

  3. Investigational medication discontinuation

    Number of patients who discontinued the investigational medication

    Measured: Day 21

  4. 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

    Measured: Day 21

  5. 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

    Measured: Day 7, 14, 21

  6. Need for intensive care

    Proportion of patients admitted to an intensive care unit

    Measured: Day 21

  7. Duration of hospitalization

    Number of days alive without hospitalization up to day 21

    Measured: Day 21

  8. Need for invasive mechanical ventilation for severe COVID-19

    Proportion of patients with initiation of invasive mechanical ventilation

    Measured: Day 21

  9. Need for oxygen therapy for COVID-19

    Proportion of patients with initiation of oxygen therapy

    Measured: Day 21

  10. Overall survival

    Proportion of patients alive at day 90

    Measured: Day 90

  11. Duration of symptoms

    Number of days alive without symptoms at day 21

    Measured: Day 21

  12. 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)

    Measured: Day 7, 14, 21

  13. SARS-CoV-2 serological assessment

    SARS-CoV2 antibodies quantification in blood

    Measured: Day 7, 14, 21 and 90

  14. Peripheral blood lymphocyte phenotyping

    Peripheral blood lymphocyte phenotyping with telomere length measurement

    Measured: Day 1, 14, 90

  15. 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

    Measured: Day 21

  16. Renal function

    estimated glomerular filtration rate

    Measured: Day 7, 14 and 21

  17. Concentration of urea in blood

    Uricemia in mmol/L or mg/dL

    Measured: Day 7, 14 and 21

  18. Concentration of potassium in blood

    Kaliemia in mmol/L

    Measured: Day 7, 14 and 21

  19. Liver function

    Liver transaminases dosage on blood sample

    Measured: Day 7, 14 and 21

  20. Liver function (2)

    Gamma-glutamyl transferase (gamma-GT) dosage on blood sample

    Measured: Day 7, 14 and 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start3 Dec 2020
  3. Primary completion27 Sep 2021
  4. Study completion2 Dec 2021

Why it stopped: Scientific committee decision due SARS-CoV2 pandemic evolution with a decrease in inclusions and widespread distribution of vaccines

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04608266
Sponsor's protocol ID
APHP200702
Acronym
CAMOVID
Status last verified
Oct 2020
First submitted
28 Oct 2020
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camostat Mesylate in people with Covid19, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Scientific committee decision due SARS-CoV2 pandemic evolution with a decrease in inclusions and widespread distribution of vaccines). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization for COVID-19 deterioration or death without hospitalization (time frame: Day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04608266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.

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