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) |
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E.1.1.1 | Medical condition in easily understood language |
Coronavirus disease 2019 (COVID-19) |
Infezione da coronavirus 2019 (COVID-19) |
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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 | 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 two remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14 |
Valutare l’efficacia di 2 regimi di RDV in termini di normalizzazione della temperatura e saturazione di ossigeno fino al Giorno 14 |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of RDV |
Valutare la sicurezza e la tollerabilità di RDV |
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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 ≥ 36.6 °C armpit, ≥ 37.2°C oral, ≥ 37.8 °C rectal 5) SpO2 > 94% on room air at screening 6) Radiographc 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 as described in Protocol Appendix 3. |
1) Disponibilità e capacità di fornire il consenso informato per iscritto prima dell’esecuzione delle procedure dello studio 2) Età = 18 anni 3) Infezione da SARS-CoV-2 confermata mediante test della PCR = 4 giorni precedenti la randomizzazione 4) Attuale ricovero ospedaliero con febbre definita come temperatura ascellare = 36,6 °C, orale = 37,2 °C, rettale = 37,8 °C 5) Saturazione dell'ossigeno (SpO2) in aria ambiente = 94% allo Screening 6) Evidenza radiografica di infiltrati polmonari 7) Uomini e donne in età fertile che abbiano rapporti eterosessuali devono acconsentire all’utilizzo di uno o più metodi contraccettivi specificati nel protocollo. |
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E.4 | Principal exclusion criteria |
1) Participation in any other clinical trial of an experimental 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) Evidence of multiorgan failure 4) Requiring mechanical ventilation at screening 5) ALT or AST > 5 x upper limit of normal (ULN) 6) Creatinine clearance < 50 mL/min 7) Positive pregnancy test (Protocol; Appendix 3) 8) Breastfeeding woman 9) Known hypersensitivity to the study drug, the metabolites, or formulation excipient |
1) Partecipazione a qualsiasi altra sperimentazione clinica di un trattamento sperimentale per COVID-19 2) Trattamento concomitante con altri agenti con effettiva o possibile attività antivirale ad azione diretta contro SARS-CoV-2 proibito < 24 ore prima della dose del farmaco sperimentale 3) Evidenza di insufficienza multiorgano 4) Necessità di ventilazione meccanica allo Screening 5) Alanina aminotransferasi (ALT) o a aspartato aminotransferasi (AST) > 5¿ il limite superiore della norma (Upper Limit of Normal, [ULN]) 6) Clearance della creatinina < 50 ml/min 7) Test di gravidanza positivo 8) Donne durante l’allattamento al seno 9) Ipersensibilità nota verso il farmaco sperimentale, i metaboliti o l’eccipiente della formulazione |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of participants in each group with normalization of fever and oxygen saturation [criteria for normalization: temperature < 36.6°C armpit, < 37.2°C oral, < 37.8°C rectal; and SpO2 > 94%, sustained for at least 24 hours] through Day 14 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From initiation of study medication until Day 14 |
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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 |
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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 | 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
|
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |