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NCT ID: NCT05031780 Recruiting - Sickle Cell Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)

Start date: February 11, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical trial is a Phase 2/3 study that will determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion.

NCT ID: NCT04976179 Completed - Clinical trials for Iron Deficiency Anemia of Pregnancy

Iron Infusion Into a Vein Compared to Iron Tablet Taken by Mouth for Treating Iron Deficiency Anemia in Pregnancy (IVON)

IVON
Start date: August 9, 2021
Phase: Phase 3
Study type: Interventional

Background: Anaemia in pregnancy is a public health burden with high incidence in Africa. Currently high dose oral iron is recommended for treatment of mild to moderate anaemia and blood transfusion for severe anaemia. The high dose oral iron is often poorly tolerated and associated with several side effects. Various parenteral iron preparations are now available for treatment of iron deficiency anaemia (IDA). The earliest of these, iron dextran is not commonly used because of its potential to cause anaphylactic reactions. Newer preparations have been found to be safer and their use for treatment of IDA is currently being evaluated. Objective: This study sought out to compare the effectiveness of intravenous ferric carboxymaltose (intervention) versus oral ferrous sulphate (control) for treating IDA in pregnancy and to compare the tolerability, safety and the cost-effectiveness of intravenous versus oral iron among pregnant Nigerian women with moderate and severe IDA at 20-32 weeks' gestation. Methodology: This study will be a hybrid Type 1 effectiveness-implementation design. 1056 eligible and consenting pregnant women with anaemia at 20 - 32 weeks gestation will be recruited. They will be randomized into either of 2 groups. Group A will have intravenous ferric carboxymaltose 20mg/kg to a maximum of 1000mg in 200mls of normal saline infusion over 15 - 20 minutes at enrolment. Group B will have oral ferrous sulphate 200mg (65mg elemental iron) thrice daily from enrolment till delivery. They will be followed up through delivery and until 6 weeks post partum. Their haemoglobin concentration, full blood count, serum ferritin and serum transferrin will be assayed at specific intervals using standard laboratory techniques. Depression will be assessed at each visit using Edinburg Postnatal Depression Scale. Cost effectiveness analysis will also be done at each visit. The primary outcome measure will be incidence of maternal anaemia and rise in haemoglobin level. Secondary outcome measures will include safety and tolerability of trial drugs, severe maternal events, incidence of infant low birth weight and incidence of depression. Statistical analysis will be done using STATA version 16.0 statistical software (STATACorp, Texas, USA).

NCT ID: NCT04969250 Completed - Covid19 Clinical Trials

Vaccination for Recovered Inpatients With COVID-19 (VATICO)

Start date: August 25, 2021
Phase: Phase 4
Study type: Interventional

In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial at selected sites who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sustained recovery, and who are still [TICO assignment] blinded and who are still within 28 to 90 days after initial TICO randomization, will be randomized in this 2x2 factorial design to one of four groups: (i) immediate versus 12 week deferral of first dose administration and also (ii) one dose only, versus two doses to be given 4 weeks apart of the Moderna mRNA-1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines). Choice of Moderna or Pfizer vaccine is determined based on availability at the site. The choice is individual, although participants vaccinated twice should receive the same type of vaccine for both injections. The primary objectives of this 2x2 factorial design are (i) to estimate the difference in neutralizing antibody (NAb) response to the mRNA vaccine from baseline to Week 48 among participants vaccinated early versus deferred, and (ii) to estimate the difference in NAb response to this vaccine among participants vaccinated once versus twice. The primary analyses will be carried out in participants randomized to placebo in TICO. Analyses will also be carried out for those who receive the investigational agent(s) studied in TICO. A key secondary objective is to ascertain the effect, if any, of SARS-CoV-2 monoclonal antibodies, and other interventions that have been studied in hospitalized COVID-19 subjects, on natural and vaccine-induced immunity. Participants will remain blinded to the interventions received in the ACTIV-3/TICO study, however allocation to the timing of vaccination and to one or two vaccinations in this (VATICO) study is not blinded.

NCT ID: NCT04950153 Active, not recruiting - Clinical trials for Adolescent HIV Infection

Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase

iCARE
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study findings will demonstrate whether or not the combination interventions for HIV testing and linkage to care and for HIV treatment outcomes, which were found to be efficacious in our prior pilot UG3 trial, will remain efficacious if scaled as proposed in this UH3 trial, across multiple sites.

NCT ID: NCT04937218 Completed - Egg Consumption Clinical Trials

Impact Evaluation of GAIN Egg Campaign in Two Nigerian States

Start date: September 9, 2019
Phase: N/A
Study type: Interventional

Improved infant and young child feeding, including dietary quality and diversity, is important for child health and development. In the 2013 Nigeria Demographic and Health Survey, only 18% of children 6-23 months of age received at least 4 food groups in the previous 24 hours. In Kaduna, one of the poorest states, dietary diversity is low and consumption of eggs is infrequent, with households reporting consuming eggs only one day per week. Eggs are a nutrient-dense food, which can contribute enormously to a child's dietary quality. This study evaluates whether a 14-month behavior change intervention about eggs can increase the procurement and consumption of eggs in children 6-59 months of age living in Nigeria. The intervention includes delivery of messages about the health benefits of eggs through Above-the-line methods and Below-the-line methods. The intervention is evaluated using a longitudinal quasi-experimental design in two states in Nigeria with pre- and post-test questionnaires designed to assess changes in acquisition and consumption of eggs.

NCT ID: NCT04935879 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

NCT ID: NCT04930198 Completed - HIV/AIDS Clinical Trials

PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The PEERNaija application will feature routine medication reminders, along with individual adherence monitoring with adherence scores, anonymized peer adherence scores (from peers attending the same clinic; social incentive), and a monthly lottery-based prize for youth with the highest adherence scores (financial incentive). The Investigators will recruit a cohort of 50 HIV-infected adolescents and young adults (AYA) to pilot the app and assess feasibility, acceptability, adoption, and preliminary efficacy of important clinical measures (including adherence and virologic suppression). The proposed study will provide important preliminary data for the role of mobile health (mHealth) platforms to harness and deliver social and financial incentives to promote adherence efforts, especially for vulnerable youth, and for a larger intervention trial evaluating this app among HIV-infected AYA in Nigeria.

NCT ID: NCT04929691 Recruiting - Clinical trials for COVID-19 Respiratory Infection

The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Among Patients With COVID-19

CircumVent
Start date: November 13, 2020
Phase: N/A
Study type: Interventional

The purpose of the CircumVent Project is to evaluate the feasibility, adaptability and acceptability of a CPAP/O2 helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria.

NCT ID: NCT04927247 Terminated - Sickle Cell Disease Clinical Trials

A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises

Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of a single dose of inclacumab, a P-selectin inhibitor, for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD). Participants will be randomized to receive either inclacumab or placebo.

NCT ID: NCT04907682 Completed - Lassa Fever Clinical Trials

Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever

SAFARI
Start date: July 30, 2021
Phase: Phase 2
Study type: Interventional

This exploratory, prospective, controlled, multisite, open label, randomized clinical trial with two treatment arms aims to compare favipiravir, a new treatment candidate for Lassa fever (LF), with the current standard of care, ribavirin. The primary endpoints of this research are (1) the description of classical pharmacokinetic parameters of favipiravir in comparison with ribavirin standard treatment in patients suffering from LF and (2) the safety and tolerability of both study drugs in the investigated regimens.