E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronavirus disease 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. |
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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
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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
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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
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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
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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) |
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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)
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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)
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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
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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. |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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 | 0 |
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.8.5 | 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 | No |
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 | 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
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LVLS OR LAST DATA POINT REQUIRED FOR STATISTICAL ANALYSIS IS RECEIVED FROM THE LAST PATIENT, WHICHEVER IS EARLIER. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
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 |