E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053983 |
E.1.2 | Term | Corona virus infection |
E.1.2 | System Organ Class | 100000004862 |
|
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 |
The study is aimed: 1) at defining if ivermectin, administered at dosage of 600 µg/kg or 1200 µg/kg QD for five consecutive days is safe in patients with initial, asymptomatic or oligosymptomatic SARS_CoV-2 infection, 2) at defining if ivermectin, administered at the dosage(s) found to be safe decreases the viral load of SARS-CoV-2 at Day 7. |
Lo studio è inteso a: 1. definire se l'ivermectina, somministrata alla dose di 600 mcg/kg o 1200 mcg/kg QD per cinque giorni consecutivi è sicura nei pazienti con infezione SARS_CoV2 iniziale, asintomatica o paucisintomatica e: 2. definire se l'ivermectina, somministrata al dosaggio (i) trovato (i) sicuro, riduce la carica virale di SARS-CoV2 al 7 ° giorno. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives To assess 1. the temporal profile of viral load at baseline, day 7, 14 and 30 2. the time to clinical cure (for symptomatic patients) 3. the proportion of patients with virological clearance at day 14 and 30. 4. the hospitalization rate. 5. the COVID-19 Severity Score at day 14 and 30 |
Valutare 1. il profilo temporale della carica virale al basale e ai giorni 7, 14 e 30 2. il tempo di remissione clinica (per i pazienti sintomatici) 3. la percentuale di pazienti con clearance virologica al giorno 14 e 30 4. il tasso di ospedalizzazione 5. il COVID-19 Severity Score ai giorni 14 e 30 |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Other types of substudies Specify title, date and version of each substudy with relative objectives: Pharmacokynetics study - Vers. 1.0 - 01.05.2020 - Objective: to evaluate the association between plasma drug concentration and clinical endpoints
|
Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Studio di Farmacocinetica - Vers. 1.0 - 01.05.2020 - Obiettivo: valutare l'associazione tra le concentrazioni plasmatiche del farmaco e gli endpoint clinici.
|
|
E.3 | Principal inclusion criteria |
• Age (>=18 years) • Positivity at RT-PCR per SARS_CoV-2 (nasopharyngeal swabs) • COVID-19 Severity Score < 3 • Patient able to take oral drugs • Informed consent to study participation and to personal data treatment |
Criterio di inclusione • Età (> = 18 anni) • Positività a RT-PCR per SARS_CoV2 (tampone nasofaringeo) • COVID-19 Severity Score <3 • Paziente in grado di assumere farmaci per via orale • Consenso alla partecipazione allo studio e al trattamento dei dati personali |
|
E.4 | Principal exclusion criteria |
Exclusion criteria: • Pregnant or lactating women (pregnancy test not required, if doubt patient is excluded) • Subjects suffering from known CNS diseases • Lack of (or inability to provide) informed consent • Patient under dialysis • Any severe medical condition with a prognosis of < 6 months • Patients under warfarin treatment • Patients under antiviral treatment • Patients under chloroquine phosphate or hydroxychloroquine |
Criteri di esclusione • Donne in gravidanza o in allattamento (non è richiesto il test di gravidanza, in caso di dubbio la paziente viene esclusa) • Soggetti che soffrono di malattie del SNC note • Mancanza (o incapacità di fornire) un consenso informato • Paziente in dialisi • Qualsiasi condizione medica grave con una prognosi inferiore a 6 mesi • Pazienti in trattamento con warfarin • Pazienti sottoposti a trattamento antivirale • Pazienti in trattamento con clorochina fosfato o idrossiclorochina |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of serious adverse drug reaction (SADR). 2. Quantitative viral load at Day 7 as measured by quantitative, digital droplet PCR.
NB: The primary outcome no.2., as well as all secondary outcomes, will be measured only if the number of SADR is less than 4 in at least one of the treatment arms. |
1. numero di reazioni avverse gravi al farmaco (SADR) 2. Carica virale quantitativa al giorno 7, misurata mediante PCR digitale
Nota: L'endpoint primario n. 2 e gli endpoints secondari verranno valutati solo se il numero delle SADR sarà inferiore a 4 in almeno uno dei bracci di trattamento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Trend over time of quantitative viral load at Day 7, 14 and Day 30 as measured by quantitative, digital droplet PCR.; Time to clinical resolution (for symptomatic patients).; Proportion of patients with virological clearance at day 14 and 30; Rate of hospitalization.; COVID-19 Severity Score at Day 14 and Day 30 |
Andamento nel tempo della carica virale misurata mediante PCR quantitativa digitale ai giorni 7, 14 e 30; Tempo alla guarigione clinica (per i pazienti sintomatici); Percentuale di pazienti con clearance virale ai giorni 14 e 30; Tasso di ospedalizzazione; COVID-19 Severity Score ai giorni 14 e 30 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 7, 14 and 30; During the follow-up period; Day 14 and 30; During the follow-up period; Day 14 and 30 |
Giorni 7,14 e 30; Durante i 30 giorni di follow-up; Giorni 14 e 30; Durante tutto il periodo di follow-up.; Giorni 14 e 30 |
|
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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
|
|
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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |