E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
The intervention has a protective objective which is to improve the clinical course of SARS-CoV-2 infection in elderly. |
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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 | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10047490 |
E.1.2 | Term | Virus identification and serology |
E.1.2 | System Organ Class | 100000004848 |
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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 |
To reduce hospital admission of elderly people during the SARS-CoV-2 outbreak. |
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E.2.2 | Secondary objectives of the trial |
To reduce SARS-CoV-2 related symptoms, the duraction of hospital admission or death of elderly people during the SARS-CoV-2 outbreak. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet the following criteria: • Adult (≥ 60 years) • Written informed consent
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E.4 | Principal exclusion criteria |
• Fever (>38 ºC) within the past 24 hours • Suspicion of current active viral or bacterial infection • Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks • Active solid or non-solid malignancy or lymphoma within the prior two years • Active participation in another research study that involves BCG administration
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E.5 End points |
E.5.1 | Primary end point(s) |
SARS-CoV-2 related hospital admission |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Between day 0 up to 12 months after inclusion |
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E.5.2 | Secondary end point(s) |
Secondary endpoints will be: • the duration of hospital admission • the cumulative incidence of documented SARS-CoV-2 infection • the number of days of self-reported fever (≥38 ºC) • the number of days of self-reported acute respiratory symptoms • the cumulative incidence of self-reported acute respiratory symptoms • the cumulative incidence of delirium due to SARS-CoV-2 • the cumulative incidence of pneumonia, skin infection, urinary tract infection, flu and gastro-intestinal infection • the cumulative incidence of death for any reason • the cumulative incidence of death due to documented SARS-CoV-2 infection • the cumulative incidence of hospital or Intensive Care Admission for any reason • the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Between day 0 up to month 12 after inclusion |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | 2 |
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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The end of the study is defined as the last patient’s last registration in the mobile application (end of follow-up period).
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |