E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
2019-nCoV acute respiratory disease |
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E.1.1.1 | Medical condition in easily understood language |
Infection in the respiratory tract caused by SARS-CoV-2 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The overall objective of the study is to evaluate the efficacy of Camostat Mesilate against COVID-19 infection among adults with COVID-19 infection. |
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E.2.2 | Secondary objectives of the trial |
1) To evaluate the safety and tolerability of the Investigational Medicinal Product (IMP) in patients with COVID-19 2) To evaluate mortality between treatment groups 3) To evaluate the need for admission to ICU including ventilator- and Extra Corporal Membran Oxygenation treatment 4) To evaluate the frequency of (re-)admission to hospital after initial discharge for COVID-19 infection 5) To evaluate the duration of oxygen supplementation 6) To evaluate time to self-reported recovery from infection 7) To evaluate time to hospital admission (Cohort 2) 8) To evaluate the rate of participant-reported secondary infection of housemates (Cohort 2)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Cohort 1: 1) Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical assay) for SARS-CoV-2 2) Less than 48 hours since time of hospital admission OR if hospital-acquired COVID-19 is suspected, less than 48 hrs since onset of symptoms 3) Adolescents and adults age >=18 years 4) Subject or legally authorized representative able to give informed consent 5) Admitted to hospital
Cohort 2: 1) Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical assay) for SARS-CoV-2 2) One or more of the following symptoms of COVID-19 infection: fever, cough, expectoration, shortness of breath, myalgia, fatigue, or head ache 3) No more than 5 days since the beginning of symptom onset 4) Adolescents and adults age >=18 years 5) Subject or legally authorized representative able to give informed consent 6) Do not require immediate hospitalization (newly diagnosed COVID-19 patients who are discharged within 24 hrs of hospital admission are eligible for enrollment) 7) Must be willing to fill out a daily symptom diary 8) Must be available for a daily phone call 9) Must be willing to take their own temperature at least twice a day
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E.4 | Principal exclusion criteria |
1) Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy 2) The following laboratory values at baseline (Day 0): o Serum total bilirubin ≥3 ULN o Estimated glomerular filtration rate (eGFR) ≤30 mL/min (based on serum creatinine) 3) Known hypersensitivity to Camostat Mesilate 4) Women who are pregnant or breastfeeding, or with a positive pregnancy test as determined by a positive urine or blood beta- human chorionic gonadotropin test during screening or women of child bearing potential* who are unwilling or unable to use an acceptable method of contraception (combined estrogen and progestogen hormonal contraception (oral, intravaginal or transdermal), progesteron-only hormonal contraception (oral, injectable or implantable), intrauterine device or intrauterine hormone-releasing system) to avoid pregnancy during the study. Sexual abstinence will only be accepted in cases where this reflect the usual lifestyle.
* Women are considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy (According to the Clinical Trial Facilitation Group, 2014-09-15). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cohort 1: Time to clinical improvement from study enrolment defined as days to live hospital discharge OR days to a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale.20,21 o The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Cohort 2: Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Dynamical; from baseline (day 0) and daily until day 30 or death, whichever comes first. |
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E.5.2 | Secondary end point(s) |
1) Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs) 2) Clinical status as assessed by the 7-point ordinal scale 3) Day 30 mortality 4) Change in National Early Warning Score (NEWS) 5) Admission to ICU 6) Days in ICU 7) (Re-)admission 8) Use of invasive mechanical ventilation or ECMO 9) Duration of supplemental oxygen (days) 10) Days to self-reported recovery (e.g. limitations in daily life activities) according to web-based questionnaires and/or during telephone interviews conducted up until day 30. 11) Number participant-reported secondary infection of housemates (Cohort 2) 12) Time to hospital admission related to COVID-19 infection (Cohort 2)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 4, 5, 6, 7, 8, 9) From baseline (day 0) to day 30 2) Day 7, 14 and 30 3, 10) Day 30 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |