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

Phase 3

Terminated

• Conditions: Covid19
• Interventions: Drug: Placebo; Drug: Camostat Mesylate

• Registration Number: NCT04608266
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Study Start: 2020-12-03
• Primary Completion: 2021-09-27
• Study Completion: 2021-12-02
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets, oral administration
Camostat mesylate	Camostat Mesylate	Camostat mesylate, oral administration 600mg/day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Need for oxygen therapy for COVID-19	Day 21	Proportion of patients with initiation of oxygen therapy
Concentration of potassium in blood	Day 7, 14 and 21	Kaliemia in mmol/L
Liver function (2)	Day 7, 14 and 21	Gamma-glutamyl transferase (gamma-GT) dosage on blood sample
Adverse events	Day 21	Number of patients with at least one adverse event
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
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)
Renal function	Day 7, 14 and 21	estimated glomerular filtration rate
SARS-CoV-2 serological assessment	Day 7, 14, 21 and 90	SARS-CoV2 antibodies quantification in blood
Concentration of urea in blood	Day 7, 14 and 21	Uricemia in mmol/L or mg/dL
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
Liver function	Day 7, 14 and 21	Liver transaminases dosage on blood sample

Trial Locations

Locations (6)

APHP - Saint Louis; 🇫🇷 Paris, France

AP-HP Hôpital Bichat; 🇫🇷 Paris, France

AP-HP Hôpital Henri Mondor; 🇫🇷 Créteil, France

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

Centre Hospitalier Sud Ile de France - Melun; 🇫🇷 Melun, France

Centre de Santé Richerand; 🇫🇷 Paris, France