| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| SARS-CoV infection |
| Infezione da SARS-CoV |
|
| E.1.1.1 | Medical condition in easily understood language |
| Coronavirus disease |
| Malattia da coronavirus |
|
| 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 | 10084268 |
| E.1.2 | Term | COVID-19 |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| 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 |
Master Protocol Number: 1.1 dated 07 April 2021
Phase 3 objectives
Part A, moderate disease. The primary objective is to determine the effect of therapeutic interventions on occurrence of disease progression in hospitalized patients with moderate COVID-19.
Part B, severe disease. The primary objective is to determine the effect of therapeutic interventions on occurrence of death in hospitalized patients with severe or critical COVID-19.
Baricitib-specific protocol v. 1.1, dated 07 April 2021: The primary objective is to determine the effect of baricitinib vs. placebo added to SoC on occurrence of death in hospitalized patients with severe or critical COVID-19. |
Master Protocol Number: 1.1 dated 07 April 2021
Parte A della Fase 3: Malattia moderata
Incidenza della progressione di malattia definita come progressione dallo stato moderato (WHO score 4-5) a severo (WHO score 6-9) o decesso (WHO score 6-9) nei 14 giorni dall’inizio del trattamento.
Parte B della Fase 3: Malattia severa
Tasso di mortalità nei 60 giorni successivi all’inizio del trattamento
Baricitib-specific protocol v. 1.1, dated 07 April 2021:
Determinare l’effetto di Baricitinib in associazione a terapia standard vs placebo in associazione a terapia standard, sull’incidenza della mortalità nei 60 giorni successivi all’inizio del trattamento in pazienti affetti da infezione severa da COVID-19. |
|
| E.2.2 | Secondary objectives of the trial |
Master Protocol Number: 1.1 dated 07 Apr 2021:
Secondary objectives are:
1. to determine the effect of therapeutic interventions on other clinical endpoints
2. to determine the effect of therapeutic interventions on viral clearance
3. to determine the effect of therapeutic interventions on biochemical parameters
4. to assess the safety impact of therapeutic interventions on major serious adverse events
5. to determine the effect of therapeutic interventions on patient reported outcomes.
Baricitinib specific protocol v. 1.1, 07 Apr 2021:
Secondary objectives are
-to compare the efficacy of baricitinib vs. placebo on disease progression, time to sustained recovery and time to first hospital discharge
-to compare baricitinib vs. placebo on major SAE
-to compare baricitinib vs. placebo on patient reported outcomes
-to compare the efficacy of baricitinib vs. placebo on viral clearance
-to compare the efficacy of baricitinib vs. placebo on markers of systemic inflammation |
Master Protocol Number: 1.1 dated 07 Apr 2021:
Gli obiettivi secondari sono:
1. determinare l'effetto di interventi terapeutici su altri endpoints clinici
2. determinare l'effetto di interventi terapeutici sulla clearance virale
3. determinare l'effetto di interventi terapeutici sui parametri biochimici
5. valutare la sicurezza di interventi terapeutici sui risultati riportati dai pazienti
Baricitinib specific protocol v. 1.1, 07 Apr 2021:
Gli obiettivi secondari sono:
- comparare l'efficacia del baricitinib vs placebo sulla progressione della malattia, sul tempo di recupero e sul tempo intercorso dal ricovero alla dimissione
- comparare l'efficacia del baricitinib vs placebo sugli eventi avversi seri
- comparare l'efficacia del baricitinib vs placebo sui risultati riportati dai pazienti
- comparare l'efficacia del baricitinib vs placebo sulla clearance virale
- comparare l'efficacia del baricitinib vs placebo sui markers dell'infiammazione sistemica |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Master Protocol Number: 1.1 dated 07 April 2021:
Participants are eligible to be included in the study only if all the following general inclusion (GI) criteria apply:
GI1. >= 18 years of age
GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR not more than 9 days old
GI3. Admitted to hospital
GI4. Informed consent by the participant or legally authorized representative.
GI5A: Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed, or
GI5B: Severe/critical disease state defined as fulfilliing at least one of the following criteria:
1. SpO2<90% on room air, or
2. SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
3. Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
4. Need of mechanical ventilation/ECMO
*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = Extracorporeal membrane oxygenation.
Additional inclusion criteria are given in the intervention-specific sub-protocols.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
All participants must be eligible according to the master protocol inclusion criteria (SolidAct Part B).
Only the general inclusion criteria (GI) for severe/critical COVID-19 are applicable:
GI1. >=18 years of age
GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR in any specimen not more than 9 days old
GI3. Admitted to hospital
GI4. Informed consent by the participant or legally authorized representative.
GI5B: Severe/critical disease state defined as fulfilling at least one of the following criteria:
1. SpO2<90% on room air, or
2. SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
3. Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
4. Need of mechanical ventilation/ECMO
*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = extracorporeal membrane oxygenation. |
Master Protocol Number: 1.1 dated 07 April 2021:
1. Età >=18 anni
2. Infezione da SARS-CoV-2 (nuova infezione o reinfezione) determinata tramite analisi con PCR in qualsiasi campione biologico prelevato non oltre i 9 giorni.
3. Ricovero in ospedale
4. Firma del consenso informato del paziente o del suo rappresentante legale autorizzato.
5. Stato della malattia severo/critico determinato da almeno uno dei seguenti parametri:
6. SpO2<90%
7. SpO2 90-94% con un chiaro trend in calo associato a distress dei parametri respiratori.
8. Necessità di ossigeno attraverso ventilazione non invasiva (CPAP, BIPAP)
9. Necessità di ventilazione meccanica con ossigeno terapia
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
1. Età >=18 anni
2. Infezione da SARS-CoV-2 (nuova infezione o reinfezione) determinata tramite analisi con PCR in qualsiasi campione biologico prelevato non oltre i 9 giorni.
3. Ricovero in ospedale
4. Firma del consenso informato del paziente o del suo rappresentante legale autorizzato.
5. Stato della malattia severo/critico determinato da almeno uno dei seguenti parametri:
6. SpO2<90%
7. SpO2 90-94% con un chiaro trend in calo associato a distress dei parametri respiratori.
8. Necessità di ossigeno attraverso ventilazione non invasiva (CPAP, BIPAP)
9. Necessità di ventilazione meccanica con ossigeno terapia |
|
| E.4 | Principal exclusion criteria |
Master Protocol Number 1.1 dated 07 April 2021:
Participants are excluded from the study if any of the following general exclusion criteria apply:
GE1. Anticipated transfer to another non-trial hospital within 72 hours
Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
GE1. Anticipated transfer to another non-trial hospital within 72 hours.
In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply:
• SE-01. Receiving cytotoxic or biologic treatments (such as tumour necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1, e.g. anakinra], anti-IL-6 [e.g. tocilizumab or sarilumab], T-cell or B-cell targeted therapies (e.g. rituximab), interferon, or Janus kinase (JAK) inhibitors (including baricitinib) for any indication at study entry.
• SE-02. Have received high dose corticosteroids at doses >20 mg prednisone (or prednisone equivalent) per day administered for =14 consecutive days in the month prior to study entry.
• SE-03. Have received dexamethasone 6 mg once daily for more than 4 days prior to screening as part of SoC for severe/critical COVID-19
• SE-04. Had COVID-related symptoms > 14 days or hospitalized > 7 days.
• SE-05. Strong inhibitors of organic anion transporter 3 [OAT3], (e.g. probenecid) that cannot be discontinued at study entry.
• SE-06. Have received neutralizing antibodies for COVID-19, except if receiving such treatment as part of EU SolidAct part A after disease progression.
• SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)).
• SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
• SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
• SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
• SE-11. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
• SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
• SE-13. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN.
• SE-14. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <15 millilitre/minute/1.73 meters squared are excluded.
• SE-15. Known hypersensitivity to baricitinib or any of its excipients.
• SE-16. Are pregnant, or intend to become pregnant or breastfeed during the study. |
Master Protocol Number 1.1 dated 07 April 2021:
1.Trasferimento anticipato del paziente presso un altro ospedale entro le 72h dal ricovero
2.Trattamenti con agenti citotossici o biologici (per esempio inibitori TNF, anti-interleuchina 1, anti IL-6, terapie target con T cell o B cell, interferone o Janus chinasi.
3.Precedenti trattamenti con corticosteroidi ad alte dosi con di prednisone, > 20 mg al giorno per 14 o più giorni, dal mese precedente dell’ingresso nello studio.
4.Precedenti trattamenti con desametasone 6mg una volta al giorno per più di 4 giorni prima dello screening per lo studio.
5.Pazienti che hanno avuto sintomi da covid-19 per più di 14 giorni, oppure ospedalizzati per più di 7 giorni.
6.Trattamento con inibitori di trasportatori organici di anioni (es. Probenecid) che non possono essere discontinuati prima dell’ingresso nello studio.
7.Trattamento con anticorpi neutralizzanti per la cura dell’infezione da COVID-19
8.Qualsiasi tipo di vaccino nelle 4 settimane antecedenti allo screening dello studio o che intendono sottoporsi a vaccinazione durante il periodo di studio.
9.Devices per la purificazione del sangue extracorporeo per la rimozione di citochine proinfiammatorie.
10.Diagnosi di tubercolosi trattata per meno di 4 settimane con terapia appropriata.
11.Sospetta infezione batterica, virale, funginea o altre infezioni che secondo l’opinione del medico possono costituire un rischio, se associate all’assunzione del farmaco in studio.
12.Diagnosi di malattie concomitanti che secondo l’opinione del medico possono inficiare la partecipazione allo studio.
13.Precedente storia di tromboembolia venosa (es. DVT) nelle 12 settimane antecedenti alla randomizzazione dello studio.
14.Storia di nota di ipersensibilità al Baricitinib
15.Gravidanza o allattamento
16.Partecipazione ad altra sperimentazione clinica che investiga altri immunomodulatori per il COVID-19.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
1.Trasferimento anticipato del paziente presso un altro ospedale entro le 72 ore dal ricovero
2.Trattamenti con agenti citotossici o biologici (per esempio inibitori TNF, anti-interleuchina 1, anti IL-6, terapie target con T cell o B cell, interferone o Janus chinasi.
3.Precedenti trattamenti con corticosteroidi ad alte dosi di prednisone, > 20 mg al giorno per 14 o più giorni, dal mese precedente dell’ingresso nello studio.
4.Precedenti trattamenti con desametasone 6mg una volta al giorno per più di 4 giorni prima dello screening per lo studio.
5.Pazienti che hanno avuto sintomi da covid-19 per più di 14 giorni, oppure ospedalizzati per più di 7 giorni.
6.Trattamento con inibitori di trasportatori organici di anioni (es. Probenecid) che non possono essere discontinuati prima dell’ingresso nello studio.
7.Pazienti che hanno ricevuto anticorpi neutralizzanti per la cura dell’infezione da COVID-19
8.Pazienti che hanno ricevuto qualsiasi tipo di vaccino nelle 4 settimane antecedenti allo screening dello studio o che intendono sottoporsi a vaccinazione durante il periodo di studio.
9.Pazienti che hanno utilizzato o che useranno devices per la purificazione del sangue extracorporeo per la rimozione di citochine proinfiammatorie.
10.Pazienti che hanno ricevuto una diagnosi di tubercolosi trattata per meno di 4 settimane con terapia appropriata.
11.Sospetta infezione batterica, virale, funginea o altre infezioni che secondo l’opinione del medico possono costituire un rischio, se associate all’assunzione del farmaco in studio.
12.Diagnosi di malattie concomitanti che secondo l’opinione del medico possono inficiare la partecipazione allo studio.
13.Precedente storia di tromboembolia venosa (es. DVT) nelle 12 settimane antecedenti alla randomizzazione dello studio.
14.AST o ALT > 5 volte ULN
15.Tasso di filtrazione glomerulare stimato < 15 mL/sec
16.Storia di nota di ipersensibilità al Baricitinib
17.Gravidanza o allattamento |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Master Protocol Number 1.1 dated 07 April 2021:
Part A, moderate disease: Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical (WHO score 6-9) or death (WHO score 10) within 14 days.
Part B, severe disease: Occurrence of death within 60 days.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
Occurrence of death within 60 days |
Master Protocol Number 1.1 dated 07 April 2021:
Endpoint primario della Parte A della Fase 3: Malattia moderata
Incidenza della progressione di malattia definita come progressione dallo stato moderato (WHO score 4-5) a severo (WHO score 6-9) o decesso (WHO score 6-9) nei 14 giorni dall’inizio del trattamento.
Endpoint primario della Parte B della Fase 3: Malattia severa
Tasso di mortalità nei 60 giorni successivi all’inizio del trattamento
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
Mortalità entro 60 giorni dall’inizio del trattamento |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Master Protocol Number 1.1 dated 07 April 2021:
Part A: Within 14 days.
Part B: Within 60 days.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
Within 60 days. |
Master Protocol Number 1.1 dated 07 April 2021:
Parte A: Entro 14 giorni
Parte B: Entro 60 giorni
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
Entro 60 giorni |
|
| E.5.2 | Secondary end point(s) |
Master Protocol Number 1.1 dated 07 April 2021:
1.1 Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical/death (WHO score 6-10) or from severe/critical (WHO score 6-9) to death within 28 days
1.2 Time from randomization to sustained recovery, defined as being discharged from the index hospitalization, followed by being alive and at home for 14 consecutive days within 90 days
1.3 Time from randomization to first hospital discharge within 90 days
1.4 Disease state on a 5-point scale defined as 1. Mild (WHO score 1-3) or better, 2. Moderate (WHO score 4-5), 3. Severe
(WHO score 6), 4. Critical (WHO score 7-9) or 5. Death at Day 15 and 29
1.5 Time from randomization to recovery defined as no need for oxygen
1.6 SpO2/FiO2-ratio at day 3, 5 and 8
2. Viral clearance as assessed by SARS-CoV-2 PCR in oropharyngeal specimens during hospitalization
3. Biochemical parameters including inflammatory markers (C-reactive protein, ferritin, lactate dehydrogenase, procalcitonin, D-dimer, leukocyte subsets and cytokine panels) during hospitalisation
4. Occurence of serious adverse events leading to study treatment discontinuation or death
5 The Oslo COVID-19 QLQ-PW80 subscale scores at Day 90
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
· Occurrence of disease progression, defined as a progression from severe (WHO score 6) to critical/death (WHO score 7-10) or from critical (WHO score 7-9) to death within 28 days
·Time from randomization to sustained recovery, with sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days within 90 days
·Time from randomization to first hospital discharge within 90 days
·Disease state on a 5 point scale defined as 1. Mild (WHO score 1-3) or better, 2. Moderate (WHO score 4-5), 3. Severe (WHO score 6), 4. Critical (WHO score 7-9) or 5. Death at Day 15 and 29
·Occurrence of serious adverse events leading to study treatment discontinuation or death
·Viral clearance as assessed by SARS-CoV-2 PCR in oropharyngeal specimens during hospitalization
·Inflammatory markers (C-reactive protein, ferritin, lactate dehydrogenase, procalcitonin, D-dimer, leukocyte subsets and cytokine panels) during hospitalisation |
Master Protocol Number 1.1 dated 07 April 2021:
1.1 Incidenza di progressione di malattia, definita come la progressione della patologia da uno stato moderato (WHO score 4-5) ad uno stato severo/critico/decesso (WHO score 6-10) o da uno stato severo/critico (WHO score 6-9) al decesso entro 28 giorni dall'inizio del trattamento.
1.2 Periodo intercorso dalla randomizzazione al recupero, definito alla dimissione, seguita da sopravvivenza.
1.3 Periodo intercorso dalla randomizzazione alla prima dimissione dall'ospedale entro 90 giorni.
1.4 Stato di malattia ad un punteggio pari a 1 in una scala di 5 punti. Discreto (WHO score 1-3) o migliore 2. Moderato (WHO score 4-5), 3. Severo (WHO score 6) 4.Critico (WHO score 7-9) o 5.Morte al giorno 15 e 29
1.5 Tempo dalla randomizzazione al ricovero senza il supporto di ossigeno
1.6 SpO2/FiO2 rapporto al giorno 3,5 e 8
2. Clearance virale stabilita da esame PCR SARS-CoV-2 su campioni orofaringei durante il ricovero
3. Parametri biochimici inclusi i marcatori infiammatori (proteina C reattiva, ferritina, LDH, procalcitonina, D-dimero, Leucociti, citochine) durante il ricovero
4. Incidenza di eventi avversi seri che causano discontinuazione dallo studio o decesso del paziente
5. Questionario sulla qualità di vita al giorno 90
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
Incidenza di progressione di malattia definita come definita come la progressione della patologia da uno stato severo (WHO score 6) a critico/morte (WHO score 7-10) o da critico (WHO score 7-9) a morte entro 28 giorni
- Periodo intercorso dalla randomizzazione al recupero, definito alla dimissione, seguita da sopravvivenza per 14 giorni consecutivi entro i 90 giorni
- Periodo intercorso dalla randomizzazione alla prima dimissione dall'ospedale entro 90 giorni.
- Stato di malattia ad un punteggio pari a 1 in una scala di 5 punti. Discreto (WHO score 1-3) o migliore 2. Moderato (WHO score 4-5), 3. Severo (WHO score 6) 4.Critico (WHO score 7-9) o 5.Morte al giorno 15 e 29
- Incidenza di eventi avversi seri che causano discontinuazione dallo studio o decesso del paziente
- Clearance virale stabilita da esame PCR SARS-CoV-2 su campioni orofaringei durante il ricovero
- Parametri biochimici inclusi i marcatori infiammatori (proteina C reattiva, ferritina, LDH, procalcitonina, D-dimero, Leucociti, citochine) durante il ricovero |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Please see above |
| Per favore vedi sopra |
|
| 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 | 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) | 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 | 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 | 20 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 130 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Turkey |
| Austria |
| Belgium |
| France |
| Germany |
| Hungary |
| Ireland |
| Italy |
| Luxembourg |
| Norway |
| Poland |
| Portugal |
| Slovakia |
| Spain |
| Czechia |
| Greece |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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