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

NCT04608266 | Terminated Phase 3 DMC

• 1 other identifier: APHP200702
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 6

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Adverse events

  Day 21

• Serious adverse events

  Day 21

• Investigational medication discontinuation

  Day 21

• Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee

  Day 21

• Clinical improvement using the Word Health Organization (WHO) COVID-19 scale

  Day 7, 14, 21

Other Outcomes (1)

• Biobanking for biomarker assessment

  Day 1, 7, 14, 21, 90

Study Arms (2)

Camostat mesylate

EXPERIMENTAL

Camostat mesylate, oral administration 600mg/day

Drug: Camostat Mesylate

Placebo

PLACEBO COMPARATOR

Placebo tablets, oral administration

Drug: Placebo

Interventions

Camostat Mesylate DRUG

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

Camostat mesylate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (6)

Centre Hospitalier Victor Dupouy

Argenteuil, France

Location

AP-HP Hôpital Henri Mondor

Créteil, France

Location

Centre Hospitalier Sud Ile de France - Melun

Melun, France

Location

AP-HP Hôpital Bichat

Paris, France

Location

APHP - Saint Louis

Paris, France

Location

Centre de Santé Richerand

Paris, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

camostat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: October 29, 2020
• Study Start: December 3, 2020
• Primary Completion: September 27, 2021
• Study Completion: December 2, 2021
• Last Updated: February 10, 2022

Record last verified: 2020-10

Locations

FR (6)