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NCT ID: NCT05311891 Not yet recruiting - COVID-19 Clinical Trials

Variants of SARS-CoV-2 Causing COVID-19 in Africa

South-Spike
Start date: September 2022
Phase:
Study type: Observational

The main objective of this research is to identify and characterize the different molecular variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine their role in the evolution of the pandemic.

NCT ID: NCT05303168 Recruiting - COVID-19 Clinical Trials

Prevalence and Impact of COVID-19 on Maternal and Infant Health in African Populations

MA-CoV
Start date: July 1, 2021
Phase:
Study type: Observational [Patient Registry]

There is growing evidence that COVID-19 threatens maternal and perinatal health. Pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched non-pregnant women. On the other hand, the number of confirmed COVID-19 cases reported in sub-Saharan Africa (SSA) continues to increase, where the highest maternal mortality rates in the world are registered. The World Health Organization (WHO) estimates that this region alone accounted for roughly two-thirds (196 000) of all maternal deaths in 2017, which among other reasons is explained by the inequalities in access to quality antenatal care (ANC) services and the low numbers of skilled health workers in the region. The spread of SARS-CoV-2 in SSA is threatening the already fragile health services, affecting mainly the most vulnerable populations such as pregnant women. This project aims to describe the burden and effects of SARS-CoV-2 infection during pregnancy in women living in malaria endemic areas and high prevalence of HIV infection. Pregnant women attending ANC clinics in selected sites from Libreville and Lambaréné (Gabon) and Manhiça (Mozambique) will be enrolled in a cohort study to determine the frequency of SARS-CoV-2 infection and COVID-19 during pregnancy and its effects on maternal and neonatal health. Participants will be tested for SARS-CoV-2 infection whenever reporting respiratory symptoms suggestive of COVID-19 during routine ANC follow-up and six weeks after the end of pregnancy. The presence of antibodies (IgG/IgM) against SARS CoV-2 in blood samples will be determined. The clinical presentation of COVID-19 in pregnancy will be also characterised, and the incidence of infection during pregnancy and the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the frequency of mother- to- child transmission of SARS-CoV-2 will be assessed. The findings of this project will contribute to the understanding of the impact of SARS-CoV-2 and COVID-19 among pregnant women living in SSA countries where malaria and HIV infections are highly prevalent.

NCT ID: NCT05222139 Recruiting - Clinical trials for SARS CoV 2 Infection

Monitoring COVID-19 Vaccination Response in Fragile Populations

ORCHESTRA-4
Start date: May 24, 2021
Phase:
Study type: Observational

The present study is part of ORCHESTRA project, a three-year international research project aimed at tackling the coronavirus pandemic. ORCHESTRA provides an innovative approach to learn from the pandemic SARS-CoV-2 crisis, derive recommendations to further management of COVID-19 and be prepared for the possible future pandemic waves. The ORCHESTRA project aims to deliver sound scientific evidence for the prevention and treatment of the infections caused by SARS-CoV-2 assessing epidemiological, clinical, microbiological, and genotypic aspects of population, environment and socio-economic features. The project builds upon existing, and new largescale population cohorts in Europe (France, Germany, Spain, Italy, Belgium, Romania, Netherlands, Luxemburg, and Slovakia) and non-European countries (India, Perú, Ecuador, Colombia, Venezuela, Argentina, Brazil and Gabon) including SARS-CoV-2 infected and non-infected individuals of all ages and conditions. The primary aim of ORCHESTRA is the creation of a new pan European cohort applying homogenous protocols for data collection, data sharing, sampling, and follow-up, which can rapidly advance the knowledge on the control and management of the COVID-19. ORCHESTRA will include SARS-CoV-2-negative individuals and thereby enable a prospective follow-up and an analysis of vaccination response. The cohort will involve four different populations: general population, COVID-19 patients, fragile individuals (children, elderly, transplanted, oncological, HIV infected, and those with Parkinson disease), and health-care workers. Each of these "perpetual" cohorts can answer different research questions and vaccine strategies. Within the ORCHESTRA project, the Work Package 4 (WP4) will focus on the cohort of fragile patients including pregnant women/new-born, children, patients with HIV infection, patients with autoimmune disease, solid organ transplant recipients, patients with oncological and hematological diseases, patients with cystic fibrosis, patients with Parkinson Disease and rheumatological diseases from from 14 countries (5 European and 9 non-European countries), with approximately 20000 subjects.

NCT ID: NCT05130398 Recruiting - Ebola Virus Disease Clinical Trials

Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Years and in Their Adults and/or Children Relatives Living in Lambaréné, Gabon

EBOLAPED
Start date: April 9, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

LA rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled open label trial. The LA rVSVΔG-ZEBOV-GP -02-PED trial aims primarily to assess the clinical significance of shedding of the rVSV RNA following vaccination with the rVSVΔG-ZEBOV-GP vaccine in children. The vaccine doses of ≥7.8 x 107 pfu will be evaluated and compared to vaccination with varicella vaccine as a control. In addition, the closest contact persons of the vaccinees will be monitored for possible transmission of the viral vaccine vector. The study will enroll children of two age groups living in Lambaréné, Gabon. Children will be followed-up for 12 months post vaccination. The 1-2 closest contact persons of each participant will be involved in the monitoring of rVSV transmission. They will be followed until day 56 post- vaccination of their children/ sibling.

NCT ID: NCT05065632 Not yet recruiting - Clinical trials for Seroprevalence of SARS-CoV-2 Infection (COVID-19) in Gabon

Seroepidemiological Investigation of Coronavirus 2019 (COVID-19) Infection in Gabon

Sero-CoV
Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

Gabon is the 3rd country most affected by COVID-19 behind Cameroon and Democratic Republic of Congo in Central Africa, with 8860 cases and 54 deaths in critically ill patients, since the first confirmed case of COVID-19 on the 10th of March 2020 (https://africacdc.org/covid-19/). Most of the individuals infected by SARS-CoV-2 are asymptomatic and they represent a major source of viral spread. To date, African countries have been less affected by deaths caused by the Covid-19 pandemic compared to other countries. It is currently unknown why Africa has avoided more deaths and appears to not simply be due to a lack of testing, since the overall death rate has not increased. Better quality data on seroprevalence in different African regions and proven explanations of the differences between Africa and other continents, are urgently needed. The aim of this study is to learn about the proportion of people after a first pic of transmission, who have been exposed to COVID-19 in Gabon by testing for plasma antibodies to the SARS-CoV-2 virus. The overall goal of this study is to examine the trend of specific anti-SARS-CoV-2 antibodies in Gabonese population.

NCT ID: NCT04847817 Recruiting - Clinical trials for Coronavirus Infection

Important Data on COVID-19 Profile in Africa

AIDCO
Start date: August 1, 2020
Phase:
Study type: Observational

The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples.

NCT ID: NCT04546633 Recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria

Start date: February 16, 2021
Phase: Phase 2
Study type: Interventional

This study aims to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of age) with uncomplicated P. falciparum malaria. There is an unmet medical need for anti-malarial treatment with a new mechanism of action to reduce the probability of developing resistance, and for a duration shorter than 3 days of treatment and/or reduced pill burden.

NCT ID: NCT04505046 Recruiting - Performance Clinical Trials

Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections.

INSPiRED-WP3
Start date: March 20, 2020
Phase:
Study type: Observational [Patient Registry]

Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect hundreds of millions of people and are an important cause of global mortality and morbidity. For the control of these poverty related parasitic diseases, and to complement chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial role. In recent years, innovative smart mobile technologies have been applied for detection and identification of cultured parasite species, which is basically based on sample imaging and parasite morphology identification. Promising advances have been made with this technology and coupled with its small size, low cost and easy to manipulate, makes it suitable for point of care diagnostics in low resource setting. The aim of the proposed explorative study is to further validate sensitivity and specificity of each of the developed devices, using besides microscopy a range of more advanced reference tests.

NCT ID: NCT04351685 Recruiting - Clinical trials for Mycobacterium Tuberculosis Infection

Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants

VPM1002
Start date: November 9, 2020
Phase: Phase 3
Study type: Interventional

The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.

NCT ID: NCT04326868 Completed - Drug Resistance Clinical Trials

Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon

BenziR
Start date: November 11, 2019
Phase: Phase 4
Study type: Interventional

Soil-transmitted helminths (STHs) infections are common in subtropics and mostly affect the poorest communities, with an impact on human health in many parts of the world. In 2017, World Health organization (WHO) reports more than 1.5 billion people are infected with soil-transmitted helminths worldwide, including 568 million school-age children who need treatment and preventive interventions. Preventive chemotherapy and periodic mass administration with benzimidazoles (BZ) [albendazole (ABZ) and mebendazole (MBZ)] are used to control these parasites. However, rapid reinfection with Ascaris lumbricoides within six months after a completed treatment has been reported, while the reinfection with hookworms is slow. Similarly, the efficacy of these drugs on Trichuris trichiura cure rate is poor. After many years of use of this drug class, there is an increase possibility that BZ resistance could develop. This resistance may occur due to single nucleotide polymorphisms (SNPs) in the β-tubulin gene at positions 167, 198 or 200, as has been reported in animals. Little data exist to show whether any of these polymorphisms do influence the BZ efficacy against STH in humans. The present study will develop methods to look for molecular evidence of BZ drug resistance in human population in order to support the investigation of the control and elimination of neglected tropical diseases (NTDs) in our communities.