E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Emerging disease (COVID-19) due to a novel coronavirus (named SARS-CoV-2 latter) started in Wuhan, China and rapidly spread in China and outside and has been declared pandemic by WHO on March 12th 2020. It has been shown that an excessive immune response to the SARS-CoV-2 virus would results in hyper-inflammation, with excessive increase of cytokines IL6 and IL10. This may progress to a cytokine storm, followed by multiorgan failure and potentially death. |
L’esperienza in corso indica che COVID19 si caratterizza come una forma di infezione caratterizzata da un esordio con sintomi influenzali per poi evolvere verso una sintomatologia alle vie respiratorie più importante caratterizzata da un quadro di polmonite e via via, in una percentuale sempre più ristretta di persone verso un quadro da insufficienza respiratoria che può evolvere fino alla ARD grave. |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19 due to a novel coronavirus (named SARS-CoV-2 latter) may progress to a cytokine storm, followed by multiorgan failure and potentially death. |
COVID19 è una forma di infezione caratterizzata da un esordio con sintomi influenzali per poi evolvere verso un quadro da insufficienza respiratoria che può evolvere fino alla ARD grave. |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063099 |
E.1.2 | Term | Viral syndrome |
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 out-of-hospital treatment with HCQ in the reducing viral loads and need for hospitalization in symptomatic SARS-CoV-2 infected patient who are confined at home. |
Lo studio quindi si propone di dimostrare l’efficacia dell’HCQ nel ridurre la crescita virale e la conseguente sintomatologia nel paziente a domicilio nella fase iniziale della malattia. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with SARS-CoV-2 infection in a nasopharyngeal sample, with diagnosis, carried out in a centralized core-lab. 2. Patients confined at home because their clinical picture was judged by the local Health authorities not severe enough to require hospitalization. 3. Patients agree to maintain seclusion at home up to viral negativization of the nasopharyngeal test in two consecutive samples, according to Italian laws. 4. Patients with 1 or more of the following symptoms/signs on the day of nasopharyngeal sample: 1) Fever (>37.0° Celsius); 2) Cough. |
1. Pazienti con infezione da SARS-CoV-2 (diagnosi effettuata in un laboratorio centrale centralizzato con modalità definite) > 18 aa ed in isolamento domiciliare obbligato 2. Che dopo informativa hanno firmato il consenso 3. in isolamento domiciliare per quadro clinico lieve caratterizzato dalla presenza si 1 o più dei seguenti sintomi / segni nel giorno del campione nasofaringeo positivo: • Febbre (> 37,0 ° Celsius); • Tosse. |
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E.4 | Principal exclusion criteria |
1. Age <18 years. 2. Allergy to HCQ or chloroquine. 3. Contraindication to treatment with the study drug for one or more of the following conditions: retinopathy, G6PD deficiency, Long-QT syndrome or treatment with drugs associated with QTc prolongation (unless these drugs can be safely discontinued during HCQ treatment). Appendix 1 shows a table, derived from AIFA, which lists these drugs. 4. Breastfeeding and pregnant patients will be excluded based on their declaration and pregnancy test results when required. |
1. Allergia a HCQ o clorochina. 2. Controindicazione al trattamento con il farmaco in studio per una o più delle seguenti condizioni: retinopatia, deficit di G6PD, sindrome del QT lungo o trattamento con farmaci associati al prolungamento del QTc (a meno che questi farmaci non possano essere interrotti in modo sicuro durante il trattamento con HCQ). (viene fornito elenco) 3. L'allattamento e gravidanza (definita in base ad auto dichiarazione e ai risultati dei test di gravidanza quando richiesto). |
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E.5 End points |
E.5.1 | Primary end point(s) |
virological clearance (nasopharyngeal sample negative for SARS-CoV-2 virus) at the sample taken on days 8. Co-primary end-point: Hospital admission over the time-interval between day 0 (randomization) and day 15. |
clearance virologica (campione rinofaringeo negativo per il virus SARS-CoV-2) al campione prelevato nei giorni 7-9. (viene fatto anche un2° test al giorno 14-17) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
a) Need for intubation during the interval between day 0 (randomization) and day 15; b) All-cause death during the interval between day 0 (randomization) and day 15. c) Virological clearance in all samples (both day 8 and day 15) d) Composite of a), b), c). The first-occurring component will be considered for analysis. |
1) esito composito: clearance virologica in tutti i campioni + ricovero ospedaliero nel corso di 2 settimane a causa di complicanze dell'infezione virale + intubazione nel corso di 2 settimane + morte nel corso di 2 settimane; 2) Ciascuno dei singoli componenti dell'endpoint secondario |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Terapia standar |
Standard therapy |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |