E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronavirus disease 2019 (COVID-19) |
Infezione da coronavirus 2019 (COVID-19) |
|
E.1.1.1 | Medical condition in easily understood language |
Coronavirus disease 2019 (COVID-19) |
Infezione da coronavirus 2019 (COVID-19) |
|
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 | LLT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus 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 efficacy of 2 RDV regimens compared to standard of care (SOC), with respect to the proportion of participants discharged on or before Day 14 |
Valutare l’efficacia di 2 regimi di RDV rispetto allo standard di cura (standard of care, SOC) in relazione alla percentuale di partecipanti dimessi il Giorno 14 o prima |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of RDV compared to SOC |
Valutare la sicurezza e la tollerabilità di RDV rispetto al SOC |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Willing and able to provide written informed consent prior to performing study procedures 2) Aged = 18 years 3) SARS-CoV-2 infection confirmed by PCR = 4 days before randomization 4) Currently hospitalized with fever defined as temperature = 36.6 °C armpit, = 37.2 °C oral, = 37.8 °C rectal 5) SpO2 > 94% on room air at screening 6) Radiographic evidence of pulmonary infiltrates 7) Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception |
1) Disponibilità e capacità di fornire il consenso informato scritto prima di eseguire le procedure dello studio 2) Età = 18 anni 3) Infezione da SARS-CoV-2 confermata mediante PCR = 4 giorni prima della randomizzazione 4) Soggetto attualmente ricoverato in ospedale con febbre definita da una temperatura ascellare = 36,6 °C, orale = 37,2 °C, rettale = 37,8 °C 5) SpO2 > 94% in aria ambiente allo screening 6) Evidenza radiografica di infiltrati polmonari 7) Uomini e donne in età fertile, che hanno rapporti eterosessuali, devono acconsentire all'utilizzo del/dei metodo/i di contraccezione specificato/i nel protocollo |
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E.4 | Principal exclusion criteria |
1) Participation in any other clinical trial of an experimental agent treatment for COVID-19 2) Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing 3) Requiring mechanical ventilation at screening 4) ALT or AST > 5 x ULN 5) Creatinine clearance < 50 mL/min 6) Positive pregnancy test (Appendix 3) 7) Breastfeeding woman 8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient |
1) Partecipazione a una qualsiasi altra sperimentazione clinica di un trattamento con agente sperimentale per COVID-19 2) Trattamento concomitante con altri agenti con effettiva o possibile attività antivirale ad azione diretta contro SARS-CoV-2 è proibito < 24 ore prima della dose di farmaco dello studio 3) Necessità di ventilazione meccanica allo screening 4) Alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) > 5¿ il limite superiore alla norma (ULN) 5) Clearance della creatinina < 50 ml/min 6) Test di gravidanza positivo 7) Donna che allatta al seno 8) Ipersensibilità nota al farmaco dello studio, ai metaboliti o all’eccipiente della formulazione |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of participants discharged by Day 14 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From initiation of study medication until Day 14 |
|
E.5.2 | Secondary end point(s) |
The proportion of participants with treatment emergent adverse events leading to study drug discontinuation |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From initiation of study medication until Day 14 |
|
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 | 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 | Yes |
E.8.1.3 | Single blind | No |
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 | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
China |
France |
Germany |
Hong Kong |
Italy |
Japan |
Korea, Republic of |
Singapore |
Spain |
Taiwan |
United States |
|
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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |