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H2020

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HORIZON-JU-GH-EDCTP3-2023-01-0...
Funding to successfully finalise EDCTP2-funded clinical trials that were negatively impacted by the COVID-19 pandemic
ExpectedOutcome:Project results are expected to contribute to the following outcomes:
Sólo fondo perdido 0 €
Europeo
Esta convocatoria está cerrada Esta línea ya está cerrada por lo que no puedes aplicar. Cerró el pasado día 04-07-2023.
Se espera una próxima convocatoria para esta ayuda, aún no está clara la fecha exacta de inicio de convocatoria.
Por suerte, hemos conseguido la lista de proyectos financiados!
Presentación: Consorcio Consorcio: Esta ayuda está diseñada para aplicar a ella en formato consorcio..
Esta ayuda financia Proyectos:

ExpectedOutcome:Project results are expected to contribute to the following outcomes:

Clinical trials of medical technologies that were funded by EDCTP2 and whose activities were disrupted during the COVID-19 pandemic, can be concluded;Information about medical technologies can be used by health care professionals and health care systems.
Scope:The following clinical trials – identified by their clinical trial registration numbers - are addressed by this topic:

ISRCTN[1] 61526229

PACTR[2]202010540737215

Assessing the safety and tolerability of artemether-lumefantrine+atovaquone-proguanil tri-therapy for malaria treatment in adults and adolescents in Gabon

ISRCTN 14750348

PACTR 202201797112873

A multicentre phase III trial to evaluate the safety, tolerability, and efficacy of a combination of three antimalaria drugs (artemether-lumefantrine+atovaquone-proguanil) versus two malaria drugs (artemether-lumefantrine) +placebo in African children aged 6-59months with an uncomplicated malaria infection

PACTR 202011812241529
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ExpectedOutcome:Project results are expected to contribute to the following outcomes:

Clinical trials of medical technologies that were funded by EDCTP2 and whose activities were disrupted during the COVID-19 pandemic, can be concluded;Information about medical technologies can be used by health care professionals and health care systems.
Scope:The following clinical trials – identified by their clinical trial registration numbers - are addressed by this topic:

ISRCTN[1] 61526229

PACTR[2]202010540737215

Assessing the safety and tolerability of artemether-lumefantrine+atovaquone-proguanil tri-therapy for malaria treatment in adults and adolescents in Gabon

ISRCTN 14750348

PACTR 202201797112873

A multicentre phase III trial to evaluate the safety, tolerability, and efficacy of a combination of three antimalaria drugs (artemether-lumefantrine+atovaquone-proguanil) versus two malaria drugs (artemether-lumefantrine) +placebo in African children aged 6-59months with an uncomplicated malaria infection

PACTR 202011812241529

Efficacy and safety of pyronaridine-artesunate (Pyramax) for the treatment of falciparum malaria in African pregnant women

NCT[3] 03876262

PACTR 202004639229710

Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis

NCT 04311671

PACTR 202003567524647

Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas

NL7294 (NTR7503) https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7503

Integrated skin screening and SDR-PEP administration for leprosy prevention: comparing the effectiveness and feasibility of a community-based intervention to a health centre-based intervention in Ethiopia, Mozambique, and Tanzania (PEP4LEP)

PACTR 202011804563392



A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA)

NCT 05119426

Effectiveness of a Typhoid Conjugate Vaccine in DRC (TyVECO)

NCT 05047315

Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV (Stool4TB)

NCT 05048472

East Africa Point of Care Viral Load Study (EAPoC-VL)

NCT 05175794

Triage Test for All Oral DR-TB Regimen (TRiAD Study)

NCT 05317247

Cough Audio Classification as a TB Triage Test (CAGE-TB)

NCT 04145258

Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis (INTENSE-TBM)

NCT 04600167

Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus (PROTID)

ISRCTN 77382043

Metformin treatment for diabetes prevention in Africa

NCT 04653948

Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital (PREPARE)

NCT 04732026

Serocorrelate of protection against GBS

NCT 04596878

Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV

PACTR202208844472053

Increasing the uptake of intermittent preventive treatment using sulfadoxine-pyrimethamine through seasonal malaria chemoprevention channel delivery

NCT05441410





Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults (SPICY)

NCT04601714

Baseline Cohort Malaria Morbidity Study (BLOOMy)

PACTR201909810587438

Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial

This funding will ensure that essential clinical trials working to deliver answers of immediate public health relevance in SSA can be concluded. Focussing funding to projects previously supported under the EDCTP2 programme is justified by the advanced stage ongoing studies have reached. It is also justified by ethical issues, such as fully validating the willingness of trial participants to take part in the clinical investigations.

The proposals need to address all of the following:

Demonstrate the work performed so far, such as number of recruited trial participants, follow-up status as well as analyses to be performed;Explain the impact of COVID-19-related delays and disruption in relation to the trial timing (start, recruitment, follow-up period);Clearly explain the additional work to be carried out, with a comprehensive plan and budget to conclude the planned studies in a tight timeframe;Proposals should present a sound assessment of the feasibility of the planned clinical investigations. Realistic plans for recruiting and following up trial subjects must be presented and corroborated by demonstrated success from previous studies and/or the current study;Whilst it is acknowledged that the projects build on previous studies, the proposals should briefly recall the justification of the choice of populations to be enrolled into the trials and explain how they relate to the larger population; It should also be explained how the full range of relevant determining characteristics (sex, gender, age, socio-economic status, etc.) is considered.

[1]https://www.isrctn.com/

[2]Pan-African clinical trials registry https://pactr.samrc.ac.za/

[3]US National Library of Medicine clinical trial registry https://clinicaltrials.gov/


Expected Impact:Expected impacts of the calls under the 2023 work programme of the Global Health EDCTP3 JU

Activities funded under the 2023 calls for proposals should contribute to:

Achieve SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African countries;Enable the implementation of the short and medium term actions foreseen by the AU EU Innovation Agenda[1] (expected to be adopted in June 2023) in the area of Public HealthProvide evidence for informed health policies and guidelines within public health systems in sub-Saharan Africa and at international level;Strengthen clinical research capability in sub-Saharan Africa to rapidly respond to emerging epidemics;Enable a regulatory environment that can ensure effective development, delivery, and uptake of new or improved safe health technologies guaranteeing that trials in sub-Saharan African countries meet international standards;Increase cost effectiveness of public investment through collaboration of funders of clinical trials in the area of infectious diseases in sub-Saharan Africa;Strengthen health systems to ensure uptake of effective health technologies and innovations;Enhance sustainable global scientific collaboration in health research and international cooperation across sub-Saharan Africa.Improve opportunities for training of researchers and healthcare professionals in sub-Saharan Africa. [1]Working document of the AU EU Innovation Agenda available online at: https://research-and-innovation.ec.europa.eu/system/files/2022-02/final_au-eu_ia_14_february.pdf


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Temáticas Obligatorias del proyecto: Temática principal:

Características del consorcio

Ámbito Europeo : La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Tipo y tamaño de organizaciones: El diseño de consorcio necesario para la tramitación de esta ayuda necesita de:
Empresas Micro, Pequeña, Mediana, Grande
Centros Tecnológicos
Universidades
Organismos públicos

Características del Proyecto

Requisitos de diseño: *Presupuesto para cada participante en el proyecto
Requisitos técnicos: ExpectedOutcome:Project results are expected to contribute to the following outcomes: ExpectedOutcome:Project results are expected to contribute to the following outcomes:
¿Quieres ejemplos? Puedes consultar aquí los últimos proyectos conocidos financiados por esta línea, sus tecnologías, sus presupuestos y sus compañías.
Capítulos financiables: Los capítulos de gastos financiables para esta línea son:
Madurez tecnológica: La tramitación de esta ayuda requiere de un nivel tecnológico mínimo en el proyecto de TRL 4:. Es el primer paso para determinar si los componentes individuales funcionarán juntos como un sistema en un entorno de laboratorio. Es un sistema de baja fidelidad para demostrar la funcionalidad básica y se definen las predicciones de rendimiento asociadas en relación con el entorno operativo final. + info.
TRL esperado:
Estadísticas proyectos financiados: Te facilitamos algunas estadísticas de los últimos 7 proyectos tramitados conocidos por categoría de empresa, porcentaje y presupuesto medio.

Categoria

%

Presupuesto medio

Grande

100%

0€

Características de la financiación

Intensidad de la ayuda: Sólo fondo perdido + info
Fondo perdido:
The funding rate for RIA projects is 100 % of the eligible costs for all types of organizations. The funding rate for RIA projects is 100 % of the eligible costs for all types of organizations.
Garantías: No existe condiciones financieras para el beneficiario.

Información adicional de la convocatoria

Efecto incentivador: Esta ayuda no tiene efecto incentivador. + info.
Respuesta Organismo: Se calcula que aproximadamente, la respuesta del organismo una vez tramitada la ayuda es de:
Meses de respuesta:
Muy Competitiva:
No Competitiva Competitiva Muy Competitiva
No conocemos el presupuesto total de la línea pero en los últimos 6 meses la línea ha concecido
Total concedido en los últimos 6 meses.
Minimis: Esta línea de financiación NO considera una “ayuda de minimis”. Puedes consultar la normativa aquí.

Otras ventajas

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