CAMOVID: A multicenter randomized trial to evaluate the efficacy and safety of camostat mesylate for the treatment of SARS-CoV-2 infection in ambulatory adult patients.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003366-39-FR

Enrollment

596

Registered

2020-07-13

Start date

2020-10-16

Completion date

Unknown

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: FOIPAN 100 mg Product Name: Camostat mesilate Pharmaceutical Form: Film-coated tablet INN or Proposed INN: CAMOSTAT MESILATE CAS Number: 59721-29-8 Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age > 18 y.o. 2) 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, dysgeusia…[WHO] 3) Informed consent to participate to the trial 4) Patients must be able and willing to comply with study visits and procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Initial need for hospitalization for COVID-19 management : defined as any of the following severity criteria : respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly (recommendations HCSP) all other reasons requiring immediate hospitalization left at the discretion of the physician 2) Pregnancy and breastfeeding 3) Participation to another interventional drug trial 4) Subject protected by law under guardianship or curatorship 5) Absence of health insurance 6) Known hypersensitivity to camostat mesylate 7) Known person sharing the same household already included in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy of camostat mesylate in the treatment of SARS-CoV-2 infection in adult patients with confirmed COVID-19 not requiring initial hospitalization, , in terms of hospitalization needs, up to day 21 after randomization;Secondary Objective: - Safety up to day 21 - Efficacy in terms of need for hospitalization for COVID-19 management, by independent blinded committee review - Overall clinical improvement at day 21 - Clinical efficacy in terms of intensive care needs, up to day 21 - Clinical efficacy in terms of time to hospitalization, up to day 21 - Clinical efficacy on respiratory functions, up to day 21 - Overall survival at day 21 and 90 after randomization - Patient-reported outcome on initial symptoms, up to day 21 - Virological, serological and immunological efficacy, up to day 21 - Renal complications, up to day 21 - Liver complications, up to day 14 ;Primary end point(s): Proportion of patients hospitalized between day 1 and day 21, for COVID-19 deterioration. Criteria for hospitalization will be the presence of any of the following: respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly [HCSP] and any all other reasons requiring hospitalization left at the discretion of the physician	—

Measure

Time frame

Main Objective: Evaluate the efficacy of camostat mesylate in the treatment of SARS-CoV-2 infection in adult patients with confirmed COVID-19 not requiring initial hospitalization, , in terms of hospitalization needs, up to day 21 after randomization;Secondary Objective: - Safety up to day 21 - Efficacy in terms of need for hospitalization for COVID-19 management, by independent blinded committee review - Overall clinical improvement at day 21 - Clinical efficacy in terms of intensive care needs, up to day 21 - Clinical efficacy in terms of time to hospitalization, up to day 21 - Clinical efficacy on respiratory functions, up to day 21 - Overall survival at day 21 and 90 after randomization - Patient-reported outcome on initial symptoms, up to day 21 - Virological, serological and immunological efficacy, up to day 21 - Renal complications, up to day 21 - Liver complications, up to day 14 ;Primary end point(s): Proportion of patients hospitalized between day 1 and day 21, for COVID-19 deterioration. Criteria for hospitalization will be the presence of any of the following: respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly [HCSP] and any all other reasons requiring hospitalization left at the discretion of the physician

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Countries

France

Outcome results