E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers, health care workers. Immune system activation after BCG vaccination. Work absenteeism and COVID-19 will be monitored. |
Raske frivillige, sundhedspersonale. Immun aktivering efter BCG vaccination. Forekomst af sygefravær og COVID-19 monitoreres. |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers, health care workers. Effect of BCG vaccination on the immune system. Work absenteeism and COVID-19 will be monitored. |
Raske frivillige, sundhedspersonale. Effekt af Calmette vaccination på immunsystemet. Forekomst af sygefravær og COVID-19 følges. |
|
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 | LLT |
E.1.2 | Classification code | 10053983 |
E.1.2 | Term | Corona virus infection |
E.1.2 | System Organ Class | 100000004862 |
|
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 absenteeism among health care workers with direct patient contacts during the COVID-19 pandemic. |
|
E.2.2 | Secondary objectives of the trial |
To reduce the number of health care workers that are infected with SARS-CoV-2 during the COVID-19 pandemic and to reduce the number of hospital admissions amongst health care workers with direct patient contacts during the COVID-19 pandemic. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult (≥18 years); Hospital personnel working at one of the participating hospitals. |
|
E.4 | Principal exclusion criteria |
Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration; Known active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species; Previous M. tuberculosis infection; Previous confirmed COVID-19 infection; Fever (>38 C) within the past 24 hours; Suspicion of active viral or bacterial infection; Pregnancy; Breastfeeding; Vaccination with other live attenuated vaccine within the last 4 weeks; Severely immunocompromised subjects. This exclusion category comprises a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy; e) subjects with primary immunodeficiency; f) treatment with any anti-cytokine therapies. g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months; Active solid or non-solid malignancy or lymphoma within the prior two years; Direct involvement in the design or the execution of the BCG-DENMARK-COVID study; Employed to the hospital < 22 hours per week. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of days of unplanned absenteeism for any reason. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study as well as weekly interim analysis. |
|
E.5.2 | Secondary end point(s) |
- The cumulative incidence of documented COVID-19. - The cumulative incidence of hospital admission for any reason. Furthermore, the following endpoints will be assessed: The number of days of unplanned absenteeism, because of documented SARS- CoV-2 infection; The number of days of absenteeism, because of imposed quarantine as a result of exposure to SARS-CoV-2; The number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented SARS- CoV-2 infection; The number of days of unplanned absenteeism because of self-reported acute respiratory symptoms; The number of days of self-reported fever (≥38 gr C); The number of days of self-reported acute respiratory symptoms; The cumulative incidence of self-reported acute respiratory symptoms; The cumulative incidence of death for any reason; The cumulative incidence of death due to documented SARS- CoV-2 infection; The cumulative incidence of Intensive Care Admission for any reason; The cumulative incidence of Intensive Care Admission due to documented SARS- CoV-2 infection; The cumulative incidence of Hospital Admission due to documented SARS-CoV-2 infection. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of study as well as monthly interim analysis. |
|
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
End of trial is defined as whichever comes latest: the last patient’s last registration in the online data collection, or 180 days. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |