E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronavirus disease 2019 (COVID-19) |
Malattia da coronavirus 2019 (COVID-19) |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19 is an infectious disease caused by a coronavirus strain. COVID-19 can lead to persistent long-term symptoms also referred to as "long COVID" in non-hospitalized patients. |
Il COVID-19 è una malattia infettiva causata da un ceppo di coronavirus. Il COVID-19 può portare a sintomi persistenti a lungo termine indicati anche come "COVID lungo" in pazienti non ospedalizzati. |
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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 | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084401 |
E.1.2 | Term | COVID-19 respiratory infection |
E.1.2 | System Organ Class | 100000004862 |
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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 evaluate the long-term symptoms of patients diagnosed with COVID-19 |
- Valutare i sintomi a lungo termine dei pazienti con diagnosi di COVID-19 |
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E.2.2 | Secondary objectives of the trial |
• To evaluate health-related quality of life (HRQoL) of patients diagnosed with COVID-19 • To evaluate medical resource utilization for patients diagnosed with COVID-19 • To evaluate the long-term outcomes of COVID-19 in patients diagnosed with COVID-19 • To evaluate adverse events in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study |
• Valutare la qualità della vita correlata alla salute (HRQoL) dei pazienti con diagnosi di COVID-19 • Valutare l'utilizzo delle risorse mediche per i pazienti con diagnosi di COVID-19 • Valutare gli esiti a lungo termine di COVID-19 in pazienti con diagnosi di COVID-19 • Valutare gli eventi avversi nei pazienti con diagnosi di COVID-19 che in precedenza erano arruolati in uno studio con RO7496998 (AT-527) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age >=18 years (regardless of weight) at the time of signing Informed Consent Form or age >=12 to <18 years (weight >=40 kg) at the time of signing Informed Consent Form (and Assent Form) • Ability, judged by the investigator, to comply with the study protocol • Patient was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) COVID-19 study. Patients who completed all study assessments in the parent study are eligible, regardless of whether patients completed or discontinued early from the study drug |
• Età >=18 anni (indipendentemente dal peso) al momento della firma del modulo di consenso informato o età da >=12 a <18 anni (peso >=40 kg) al momento della firma del modulo di consenso informato (e modulo di assenso) • Capacità, giudicata dallo sperimentatore, di rispettare il protocollo di studio • Al paziente è stato diagnosticato il COVID-19 ed è stato arruolato in uno studio di Fase III RO7496998 (AT-527) COVID-19. Sono eleggibili i pazienti che hanno completato tutte le valutazioni dello studio nello studio genitore, indipendentemente dal fatto che i pazienti abbiano completato o interrotto anticipatamente il farmaco in studio |
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E.4 | Principal exclusion criteria |
• Participation in an interventional study at the time of enrollment or plans to enroll in an interventional study during this study • Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study |
• Partecipazione a uno studio interventistico al momento dell'iscrizione o prevede di iscriversi a uno studio interventistico durante questo studio • Qualsiasi condizione medica grave o anomalia dei test clinici di laboratorio che, a giudizio dello sperimentatore, precluda la partecipazione sicura del paziente e il completamento dello studio |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Descriptive summaries, over time, of COVID-19 symptoms, as assessed through the COVID-19 Symptom Diary (Items 1-14) |
1. Riepiloghi descrittivi, nel tempo, dei sintomi di COVID-19, valutati tramite il Diario dei sintomi di COVID-19 (punti 1-14) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. From Day 1 up to approximately 6 months (Weekly) |
1. Dal giorno 1 fino a circa 6 mesi (settimanale) |
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E.5.2 | Secondary end point(s) |
1. Impact of dyspnea symptoms on specific activities, as assessed through use of Patient Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Questionnaire at Day 1 and Months 1, 2, 3, 4, 5, and 6 2. Respiratory-specific HRQoL, as assessed through use of St. George's Respiratory Questionnaire (SGRQ) at Day 1 and Months 1, 2, 3, 4, 5, and 6 3. Proportion of patients with COVID-19 related medically attended visits through to study end (defined as hospitalization, emergency room visit, urgent care visit, physician's office visit, or telemedicine visit with the primary reason for the visit being COVID-19 or COVID-19 related symptoms) 4. Proportion of patients with all-cause mortality 5. Proportion of patients with death attributable to progression of COVID-19 6. Proportion of patients re-infected with Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) 7. Proportion of patients with any post-treatment infection including but not limited to bacterial, viral, or fungal pneumonia or sepsis 8. Frequency of COVID-19 related complications (e.g. death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure sepsis, coagulopathy, pericarditis, myocarditis, cardiac failure) 9. Incidence and severity of adverse events and serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) |
1. Impatto dei sintomi della dispnea su attività specifiche, come valutato attraverso l'uso delle informazioni sulla misurazione degli esiti riferiti dal paziente Sistema (PROMIS) - Questionario sulla dispnea al giorno 1 e ai mesi 1, 2, 3, 4, 5 e 6 2. HRQoL respiratorio specifico, valutato mediante l'uso del St. George's Respiratory Questionnaire (SGRQ) al giorno 1 e ai mesi 1, 2, 3, 4, 5 e 6 3. Percentuale di pazienti con visite mediche correlate al COVID-19 fino alla fine dello studio (definito come ricovero ospedaliero, pronto soccorso visita, visita di assistenza urgente, visita presso lo studio medico o visita di telemedicina con il motivo principale della visita correlato a COVID-19 o COVID-19 sintomi) 4. Percentuale di pazienti con mortalità per tutte le cause 5. Percentuale di pazienti con morte attribuibile alla progressione di COVID-19 6. Percentuale di pazienti re-infettati con sindrome respiratoria acuta grave coronavirus-2 (SARS-CoV-2) 7. Percentuale di pazienti con qualsiasi infezione post-trattamento inclusa, ma non limitata a, polmonite o sepsi batterica, virale o fungina 8. Frequenza delle complicanze correlate al COVID-19 (ad es. morte, ospedalizzazione, polmonite confermata radiologicamente, respirazione acuta sepsi, coagulopatia, pericardite, miocardite, insufficienza cardiaca) 9. Incidenza e gravità degli eventi avversi e degli eventi avversi gravi, con gravità determinata secondo i criteri comuni di terminologia per gli eventi avversi del National Cancer Institute, versione 5.0 (NCI CTCAE v5.0) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-2. At Day 1 and Months 1, 2, 3, 4, 5, and 6 3-9. Up to approximately 6 months |
1-2. Al giorno 1 e ai mesi 1, 2, 3, 4, 5 e 6 3-9. Fino a circa 6 mesi |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
This is a Phase III, non-treatment, observational, multicenter, follow-up study to assess long-term outcomes for approx. six months in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 study. |
Questa è una fase III, senza trattamento, osservazionale, multicentrica, di follow-up studio per valutare i risultati a lungo termine per ca. sei mesi nei pazienti con diagnosi di COVID-19 che in precedenza aveva partecipato a uno studio con RO7496998. |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Questo è uno studio non terapeutico senza farmaco in studio. Non è randomizzato, studio osservaziona |
This is non treatment study with no study drug. It is non randomized, observational study. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 70 |
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 |
Brazil |
Colombia |
Japan |
Mexico |
Peru |
Russian Federation |
Serbia |
Turkey |
Ukraine |
United States |
Belgium |
Denmark |
France |
Germany |
Hungary |
Italy |
Poland |
Portugal |
Romania |
Spain |
Switzerland |
United Kingdom |
Argentina |
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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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LVLS OR LAST DATA POINT REQUIRED FOR STATISTICAL ANALYSIS IS RECEIVED FROM THE LAST PATIENT, WHICHEVER IS EARLIER. |
LVLS O ULTIMO PUNTO DATI RICHIESTO PER L'ANALISI STATISTICA È RICEVUTO DALL'ULTIMO PAZIENTE, QUALUNQUE AVVENGA PRIMA. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |