E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
New Coronavirus infection |
Infección por el coronavirus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 efficacy and safety of the use of Ivermectin in the treatment of SARS-COV2 ambulatory patients. |
Evaluar la eficacia y seguridad del tratamiento con Ivermectina en el tratamiento de infección por SARS-COV2 ambulatorios. |
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E.2.2 | Secondary objectives of the trial |
To analyze clinical parameters To evaluate the |
1. To Analyze the improvement in clinical parameters (symptoms and physical examination). 2. To Assess the clinical cure rate after 2 weeks of treatment. 3. To Evaluate the microbiological cure rate 72 h after treatment. 4. To Assess the failure rate and admission requirements for disease progression. 5. To Analyze the factors of weak or poor response to ivermectin. 6. To Analyze adverse events to treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients over 50 years of age with comorbidities, diagnosed with SARS-Cov 2 infection by PCR or another diagnostic test performed in the emergency department, who are in the first week of clinic, without pneumonia and without admission criteria. • Patients between 18 and 70 years old (both inclusive) with pneumonia associated to SARS-Co2 infection: Cough or expectoration and / or fever> 38ºC + - Radiological infiltrate in Rxtórax; with SARS-Co2 PCR or radiological, clinical and analytical findings of COVID-19. • Evolution time of initial symptoms between 3 and 8 days. • Basal oxygen saturation> = 93% by breathing ambient air. • Have signed the informed consent. |
• Pacientes mayores de 50 años y comorbilidades con diagnóstico de infección por SARS-Cov 2 diagnosticados mediante PCR u otro test diagnóstico realizado en urgencias, que se encuentre en la primera semana de clínica, sin Neumonía y sin criterios de ingreso. • Pacientes entre 18 y 70 años (ambos inclusive) con neumonía asociada a infección por SARS-Co2: Tos o expectoración y/o fiebre > 38ºC + - Infiltrado radiológico en Rxtórax; con PCR SARS-Co2 o hallazgos radiológicos, clínicos y analíticos de COVID-19. • Tiempo de evolución de sintomatología inicial entre 3 y 8 días. • Saturación basal de oxígeno >= 93% respirando aire ambiente. • Que hayan firmado el consentimiento informado. |
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E.4 | Principal exclusion criteria |
• Patients with Pneumonia due to SARS-COV2 that requires hospital admission, due to multilobar involvement, respiratory failure P02 <93% ambient air or <92% for COPD patients; with analytical criteria of severity (D-dimer> 600, CRP> 50, lymphopenia <900, ferritin> 700 mg / dL, Il-6 or organ failure of the organ or who have significant comorbidities: Renal insufficiency> 3B; immunosuppression, cancer; chronic cirrhosis or liver disease, diabetes mellitus, atherosclerosis of any territory, heart rhythm disturbances (including prolonged QT), poorly controlled HT. • Patients with QT range > 500ms. • Patients under 18 years of age. • Chilg-Pugh C liver failure. • Impossibility of giving treatment for non-suppressible drugs with the risk of QT prolongation or interactions (antidepressants, antihistamines, quinolones, statins except pitavastatin) or allergy to the drug. • Taking any of the drugs in the trial within 7 days prior to inclusion in the study • Pregnancy, lactation |
• Pacientes con Neumonía por SARS-COV2 que requiera ingreso hospitalario, por afectación multilobar, insuficiencia respiratoria P02 < 93% aire ambiente o <92% para pacientes EPOC; con criterios analíticos de gravedad (Dímero D >600, PCR >50, linfopenia< 900, ferritina >700 mg/dL, Il-6 o fracaso de órgano de órgano o que tengan comorbilidades significativas: Insuficiencia renal >3B; inmunosupresión, cáncer; cirrosis o hepatopatía crónica, diabetes mellitus, aterosclerosis de cualquier territorio, alteraciones del ritmo cardiaco (incluida QT prolongado), HTA mal controlada. • Pacientes con QT >500ms. • Pacientes menores de 18 años. • Insuficiencia hepática Chilg-Pugh C. • Imposibilidad de dar tratamiento por fármacos no suprimibles con riesgo de prolongación QT o interacciones (antidepresivos, antihistamínicos, quinolonas, estatinas salvo pitavastatina)o alergia al medicamento. • Toma de alguno de los fármacos en ensayo de en los 7 días previos a la inclusión en el estudio • Embarazo, lactancia |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy will be measured by comparing clinical cure, Microbiology, need for hospital admission due to clinical or analytical, blood gas and / or radiological deterioration for each arm. |
La eficacia se medirá comparando curación clínica, Microbiologia, necesidad de ingreso hospitalario por empeoramiento clínico o analítico, gasometrico y/o radiológico para cada brazo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Two weeks since the start of the tratment |
A las dos semanas del inicio del tratamiento |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Two weeks since the start of the tratment |
A las dos semanas del inicio del tratamiento |
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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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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 |
Última visita del último paciente |
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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 | |