- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04354597
Hydroxychloroquine and Azithromycin as Prophylaxis for Healthcare Workers Dealing With COVID19 Patients (MOPHYDA)
A Multicenter, Open-label, Pilot Study on Using Hydroxychloroquine (HCQ) and Azithromycin (AZ) Prophylaxis for Healthcare Workers With a Potential Risk of Exposure to COVID-19 Patients
Descripción general del estudio
Descripción detallada
Exceptional efforts have been paid globally to apply the latest and most effective means of universal standard precautions throughout the settings facing COVID-19 crisis, and this is led by health care providers who are more vulnerable and have a higher risk of getting the infection (8.3% in Italy) and a higher rate of complications and mortality with some reports suggesting high mortality among these individuals.
While several clinical trials are underway across the globe to examine the effect of chloroquine at the moment, the number of COVID-19 cases is still on the rise and health care workers are facing a very high risk of getting the infection. In this study, we aim to study prophylactic efficacy of the combination (HCQ and AZ) among health care professionals in a 16 weeks period.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Amman, Jordán
- King Hussein Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Medical doctors, Nurses and Respiratory therapists caring for COVID-19 patients in ER and ICU and dedicated COVID19 units.
- Age between 18 and 70 years old.
- Male or non-pregnant, non- lactating female.
- Availability for follow up by phone.
- Willing to participate and provide signed informed consent.
Exclusion Criteria:
- Subjects with a history of retinopathy, sickle cell disease or trait, psoriasis, or porphyria.
- Subjects who take certain prescribed or over the counter (OTC) concomitant medication including ampicillin, cimetidine, digoxin, statins, cyclosporine, warfarin, fluconazole, within 2 weeks of dosing start, and during the duration of the study.
- Current Symptoms of Fever, Cough, or Shortness of Breath.
- PCR confirmed positive test of COVID-19.
- Weight < 40 kg.
- Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at the screening.
- Allergy to any of the study medications.
- History of splenectomy.
- Infection with hepatitis B or C viruses.
- Chronic or active neurologic disease including seizure disorder and chronic migraine headaches.
Any abnormal baseline laboratory screening tests listed below
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)above twice the upper limit of normal for the reference lab.
- Creatinine above the normal range.
- Hemoglobin for males <12.5 g/dl and females <10.5 g/dl.
- Platelet count of <150 X 103/L.
- Total white blood cell (WBC) count out of normal range Note: If screening lab values are out of the normal range but are expected to be temporary (e.g. due to dehydration), they may be re-assessed one more time at the discretion of the investigator.
- An abnormal baseline screening ECG suggestive of cardiac disease as determined by a clinical investigator. QTcF of >450 msec for males and >470 msec for females.
- Any other significant finding that based on the judgment of the PI would increase the risk of having an adverse outcome from participating in this study
- Subjects known to have a mental illness
- Subjects who have Skin disorders (including rash, dermatitis, and psoriasis)
- Hematological disease.
- Cardiovascular disease.
- G6PD deficiency.
- Lactose intolerance.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Study Arm A (HCQ & AZ)
Subjects will receive weekly HCQ 400mg X 1 Day PO and AZ 500mg PO X 3 Days; weekly for 16 weeks.
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Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.
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Sin intervención: Study Arm B (No treatment)
Subjects will receive no treatment in this group and will be serving as control.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients
Periodo de tiempo: 4 Months
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Compare the proportion of participants who have RT-PCR confirmed infection with SARS-CoV-2 in both arms during the study period, measured by negative PCR test for SARS COV-2 virus
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4 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety of HCQ and AZ
Periodo de tiempo: 4 Months
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Solicited and unsolicited adverse events in participants receiving HCQ+AZ during the study period, measured by the incidence of AEs in both arms.
(The difference in type, number, and intensity)
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4 Months
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Oxygen requirement
Periodo de tiempo: 4 Months
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The proportion of participants who require oxygen therapy for any indication during the study period in both arms, measured by the requirement for O2 or not in both arms.
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4 Months
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ICU admission
Periodo de tiempo: 4 Months
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The proportion of participants who need ICU admission for any reason during the study period in both arms, measured by the incidence of ICU admission in both arms.
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4 Months
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Mortality rate
Periodo de tiempo: 4 Months
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The proportion of participants who die of any cause during the study period in both arms, measured by the incidence of death in both arms.
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4 Months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20 KHCC 67
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre COVID-19
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PfizerActivo, no reclutandoCOVID-19 | Enfermedad por coronavirus 2019 (COVID-19) | Contagio de COVID-19 | Vacunas para COVID-19 | Infección por SARS-CoV-2, COVID19 | Vacunación COVID-19 | Infección por SARS-CoV-2, COVID-19 | COVID-19 (Enfermedad por coronavirus 2019) | Infección por COVID-19 SARS-CoV-2Estados Unidos
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Shanghai Public Health Clinical CenterAún no reclutando
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Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Terminado
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European Institute of OncologyFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; Azienda Ospedaliera Niguarda... y otros colaboradoresTerminado
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Owlstone LtdCambridge University Hospitals NHS Foundation TrustTerminado
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Eggensberger OHGBavarian Health and Food Safety Authority (LGL)ReclutamientoCondición posterior a COVID-19 | Publicar COVID-19 | Síndrome post COVID-19 | Síndrome largo de COVID-19 | Condición posterior a COVID-19 (PCC)Alemania
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Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaReclutamientoFatiga | Síndrome Post-COVID-19 | Condición posterior a COVID-19 | Síndrome Post-COVID | Largo COVID-19 | Largo-COVID | Condición post-COVIDCanadá
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PfizerReclutamientoEnfermedades de las vías respiratorias | COVID-19 | Neumonía | Enfermedades pulmonares | Enfermedad del coronavirus 2019 | Enfermedad por coronavirus 2019 (COVID-19) | Contagio de COVID-19 | Infecciones del Tracto Respiratorio Superior | Infección del tracto respiratorio | COVID-19 (Enfermedad por coronavirus... y otras condicionesBélgica
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Yang I. PachankisActivo, no reclutandoInfección respiratoria por COVID-19 | Síndrome de Estrés COVID-19 | Reacción adversa a la vacuna COVID-19 | Tromboembolismo asociado a COVID-19 | Síndrome Post-Cuidados Intensivos COVID-19 | Accidente cerebrovascular asociado con COVID-19Porcelana
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RSUP PersahabatanTerminadoSíndrome post COVID-19 | Síndrome largo de COVID-19 | Síndrome Post COVID Long COVIDIndonesia
Ensayos clínicos sobre HCQ & AZ
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Azafaros A.G.TerminadoEnfermedad de Niemann-Pick, tipo C | Gangliosidosis GM2Brasil
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Alexza Pharmaceuticals, Inc.CelerionTerminado
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Azafaros A.G.ReclutamientoGangliosidosis GM2 | Enfermedad de Niemann-Pick tipo CBrasil
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King Hussein Cancer CenterRetirado
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University of Alabama at BirminghamAstraZenecaTerminadoEnfermedad del hígado graso no alcohólico (EHGNA) | Esteatohepatitis no alcohólica (EHNA)Estados Unidos
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UnitedHealth GroupUniversity of Pennsylvania; ProHealth Care AssociatesTerminadoContagio de coronavirus | CoronavirusEstados Unidos
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Novartis PharmaceuticalsTerminado
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Azafaros A.G.ReclutamientoGangliosidosis GM2 | Gangliosidosis GM1 | Enfermedad de Niemann-Pick tipo CFrancia, Reino Unido, Italia, Australia, Estados Unidos, México, Canadá, Brasil, Portugal, India, España, Turquía (Türkiye), Alemania, Suecia, Argentina, Suiza
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Azafaros A.G.ReclutamientoGangliosidosis, GM1 | Gangliosidosis, GM2Francia, Reino Unido, Italia, Australia, Estados Unidos, México, Canadá, Brasil, Portugal, India, España, Turquía (Türkiye), Alemania, Suecia, Argentina, Suiza
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Guang'anmen Hospital of China Academy of Chinese...DesconocidoArtritis ReumatoidePorcelana