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NCT ID: NCT05202288 Not yet recruiting - Ebola Virus Disease Clinical Trials

Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers

Start date: March 2022
Phase: Phase 2
Study type: Interventional

Ebola virus disease (EVD) is emerging regularly in various African countries for various reasons: during contact with mortal remains, during an unsafe burial or following the viral dissemination around a recovered patient. However, tools to fight the spread of the disease are being made available to countries affected by MVE. A vaccine (Ervebo), developed by the Merck laboratory, demonstrated its efficacy in protecting contacts and contacts of contacts in the "Ebola That's Enough" trial and two monoclonal antibodies (Mabs) have demonstrated their efficacy in reducing mortality in patients with EVM: REGN-E3B and Mab114. The question of their use in post-exposure prophylaxis (PEP), defined as the treatment of contacts at very high risk of contracting EVD, is essential. Vaccination with Ervebo alone does not appear to be a good option for PEP, particularly because antibody synthesis is delayed, and the vaccine is likely to be inactive for 10 days after administration. Monoclonal antibodies, on the other hand, seem to be a promising avenue in this indication because of their rapid action on the inhibition of virus entry into the cell. Moreover, Ervebo vaccine and monoclonal antibodies share the same viral target. It is therefore possible that the vaccine is inhibited by the monoclonal antibodies, particularly in the case of concomitant administration. However, no data on vaccine efficacy in combination are available. The question of the interaction between the monoclonal antibody and Ervebo and the delay between the administration of these two strategies remains unresolved. The hypothesis of this trial is that Ervebo vaccine efficacy is diminished with the concomitant administration of a monoclonal antibody, especially if this administration is close (short time between Mabs and vaccination). We hypothesize that with an optimal delay between Mabs and vaccination, the immunogenicity of the vaccine combined with monoclonal antibodies could be non-inferior to the vaccine alone, thus providing optimal short and long term protection. The primary objective of this study is to compare the vaccine immune response at 24 weeks induced by Ervebo administered on the same day (D0) or at S3, S6, or S12 of Inmazeb administration, in healthy volunteers, with vaccination with Ervebo alone. The trial will have 5 arms. The control arm (vaccination alone) will serve as a comparator of vaccine response in the intervention arms. The 4 intervention arms will assess the minimum time between Mab and vaccination.

NCT ID: NCT05096091 Recruiting - COVID-19 Clinical Trials

International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)

Start date: August 16, 2021
Study type: Observational

InVITE is funded by NIAID and is conducted in multiple international sites (approximately 20 sites across 7 countries). This is a study of adults who receive locally available COVID-19 vaccines through local vaccination programs. Persons will be enrolled within one day (before or after) of receipt of a COVID-19 vaccine. The study will enroll participants who receive COVID-19 vaccination at local clinics and/or study sites.

NCT ID: NCT04920838 Recruiting - Covid19 Clinical Trials

Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection

Start date: April 12, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Coverage Africa is a nested study in the large Anticov platform trial that aims to generate data on new early treatment strategies for mild/moderate COVID-19 patients in resource-limited-settings to reduce the number progressing to severe forms requiring hospitalization, thereby relieving the burden on health care systems and contributing to "flattening the curve" in contexts where none pharmaceutical intervention such as quarantine are difficult to implement in large urban settings. Treating early when the virus is still present might also limit transmission. Coverage Africa will be conducted in Guinea and Burkina Faso. The main objective is to conduct an open-label, multicenter, randomized, adaptive platform trial to test the safety and efficacy of several marketed products, including antiviral therapies versus control in mild/moderate of coronavirus disease 2019 (Covid-19) in resource-limited-settings. The study aims to recruit 600 patients in both countries, one site in Guinea and two sites in Burkina Faso. The two assessed treatments are now the association of Ciclésonide / Nitazoxanide and the Telmisartan, compared with a control arm: paracetamol. The adaptive design trial will allow for the removal of drugs, or the addition of new study arms when new data becomes available. Data on the primary efficacy parameters and safety will be integrated with the primary endpoint based on an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment, including death for any reason. Study will run until December 2021. However, with the proposed adaptive design, the study could also be interrupted for success earlier than planned with the identification of a treatment that significantly reduces hospitalization rate as evidence by results from the primary endpoint.

NCT ID: NCT04912284 Completed - Covid19 Clinical Trials

Africa COVID-19 Vaccine Hesitancy

Start date: May 5, 2021
Study type: Observational

Vaccine hesitancy is defined by the WHO's Strategic Advisory Group of Experts on Immunization as a 'delay in acceptance or refusal of vaccination despite availability of vaccination services'. This varies in form and intensity based on when and where it occurs and what vaccine is involved. Several prophylactic vaccines against COVID-19 are currently available. As the world is beginning the roll-out the first approved vaccines, little is known about people's potential acceptance of a COVID-19 vaccine in most of the African countries. ACHES (African COVID -19Vaccine Hesitancy) is an observational study aimed at measuring COVID-19 vaccine hesitancy in five west African countries and exploring causes behind the hesitancy with the main objective of informing guidelines for the proficient roll-out of the vaccines in the region.

NCT ID: NCT04885543 Completed - Covid19 Clinical Trials

COVID-19 STAndard of Care in Sub-Saharan Africa

Start date: March 1, 2020
Study type: Observational

This study was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. The data were recorded using the WHO COVID-19 rapid core case report form.

NCT ID: NCT04822376 Not yet recruiting - Ebola Virus Disease Clinical Trials

Prophylaxis Vaccine Antibodies Ebola

Start date: October 17, 2021
Phase: Phase 2
Study type: Interventional

- Three measures are currently being implemented to control Ebola outbreaks: - Monitoring of contacts - Isolation and treatment of sick people - Vaccination of the population in high-risk areas. - In contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-VSV-ZEBOV vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration. - Specific monoclonal antibodies (Mab) from the Regeneron and mAb114 research specialties have been shown to be effective in reducing mortality in patients with Ebola virus disease (EVD). - Their use in a single parenteral administration and good tolerability make them candidates for use in post-exposure prophylaxis (PEP) in individuals at high risk of viral exposure. - A comprehensive strategy for the protection of high-risk contacts must therefore be implemented, including the vaccine and the Mabs, to ensure both immediate and prolonged protection. Indeed, the efficacy of the vaccine is likely to be diminished when co-administered with Mabs, as both strategies share the same viral target (the GP envelope glycoprotein) and the vaccine is replicative (and therefore may be inhibited by Mabs). PROVAE aim to evaluate the effectiveness of a comprehensive strategy to prevent transmission of MVE in contacts at high risk of infection, including (i) post-exposure prophylaxis with Mabs and (ii) vaccination with r-VSV-ZEBOV.

NCT ID: NCT04738812 Not yet recruiting - Tuberculosis Clinical Trials

Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression

Start date: September 2021
Phase: Phase 3
Study type: Interventional

DATURA trial is a phase III, multicenter, two-arm, open-label, randomized superiority trial to compare the efficacy and the safety of an intensified tuberculosis (TB) regimen versus standard TB treatment in HIV-infected adults and adolescents hospitalized for TB with CD4 ≤ 100 cells/μL over 48 weeks: - Intensified TB treatment regimen: increased doses of rifampicin and isoniazid together with standard-dose of pyrazinamide and ethambutol for 8 weeks in addition to prednisone for 6 weeks and albendazole for 3 days - WHO standard TB treatment regimen. The continuation phase of TB treatment will be identical in the two arms: 4 months of rifampicin and isoniazid at standard doses.

NCT ID: NCT04502342 Enrolling by invitation - Covid19 Clinical Trials

Add on to Azythromycine, Phytomedicine and/or Antimalarial Drug vs Hydroxychloroquine in Uncomplicated COVID-19 Patients

Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

The phase II clinical trial, with three arms and at rate of 10 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non inferiority test aimed to compare the efficacy and safety in add on to Azithromycin, an antimalarial drug, a treatment combination of the antimalrial drug with an antiviral phytomedicine versus Hydroxychloroquine in COVID-19 patients without complications. During the treatment, viral clearance, adverse effects related to treatment, and symptoms progression will be assessed on days 3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the 3-month trial. Ethical and deontological considerations will be applied.

NCT ID: NCT04501965 Enrolling by invitation - Covid19 Clinical Trials

Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azythromycin in Asymptomatic Covid-19 Patients

Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

Our previous work on plants has indicated significant antimalarial and antiviral activities. Of these plants, two recipes are proposed for evaluation for COVID-19. It is Cinchona, an antimalarial and a combination of 4 plants with antiviral, antimalarial, antitussive and anti-inflammatory properties. The phase II clinical trial, with three arms and at a rate of 77 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non-inferiority test aimed at comparing the therapeutic impact in "add on" to Azithromycin, phytomedicines versus Hydroxychloroquine in asymptomatic COVID-19 patients. After 10 days of treatment, viral clearance and symptom progression will be assessed on days 3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the 3-month trial. Ethical and deontological considerations will be applied

NCT ID: NCT04105855 Recruiting - Malaria Clinical Trials

Malaria Prevalence Around Maferinyah, Guinea

Start date: July 13, 2020
Study type: Observational

Background: Many women in Sub-Saharan Africa get malaria while they are pregnant. Plasmodium falciparum is a parasite that can cause malaria. Placental malaria (PM) caused by P. falciparum can cause anemia or death in first-time mothers. In infants, it can cause low birth weight, premature birth, or other problems. Some women don t show any signs of having PM. This makes it harder to know if they might have it. Researchers want to learn how much the seasons affect the number of women and infants who get PM as well as the severity of the disease. To do this, they are going to test women and babies who visit a health center in Guinea. Objective: To learn the seasonal burden of P. falciparum infection in pregnant women and otherwise healthy infants. Eligibility: Pregnant women ages 18 years and older (or emancipated minors) and infants ages 6-12 months. Design: Participants will include women and infants who visit the health center in Maf(SqrRoot)(Registered Trademark)rinyah, Guinea, for routine care. They can take part only once per pregnancy. For screening, mothers will talk about their medical history. They will talk about their past pregnancies and their current pregnancy. They will answer questions about where they live and what they do to keep from getting malaria. Babies will be screened with their medical history and demographic information. Participants will also give a blood sample. Adults will have a finger stick. Children will have a heel stick. Or they will have blood taken from a vein. Participation will last for 1 visit to the health center.