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NCT ID: NCT03309020 Not yet recruiting - Cataract Clinical Trials

PREVAIL VII: Persistence of Ebola Virus in Aqueous Humor and Outcomes of Cataract Surgery in Survivors of Ebola Virus Disease

Start date: October 25, 2017
Phase: N/A
Study type: Observational

Objective: Zaire ebolavirus is a single-stranded RNA virus associated with high morbidity and mortality. The most recent epidemic of Ebola virus disease (EVD) in West Africa resulted in over 11,000 deaths and disabling sequelae among survivors, among which eye complications are highly represented. Chronic intraocular inflammation and viral persistence may result in posterior synechiae and cataract formation, resulting in loss of visual acuity and requiring surgical intervention to resolve. Approximately one out of ten Ebola survivors present with cataract, most of whom will require intraocular surgery during their lifetime, and many of whom require intervention in the near future to regain quality of life. For survivors who are blind from cataract, cataract extraction is necessary to restore visual function, allow reintegration into society and facilitate performance of activities of daily living. However, surgical parameters among Ebola survivors are unknown, including whether Ebola viral RNA persists in aqueous humor, whether additional anti-inflammatory medication is needed, and the expected degree of improvement in visual function. Moreover, sites of viral persistence are unknown, and it is unclear if lens tissues removed during cataract surgery may harbor virus in Ebola-affected eyes. We propose following EVD survivors and control subjects undergoing cataract surgery to determine visual outcomes among Ebola survivors and explore detection of the presence of virus in lens tissues. The data will inform both future surgical intervention and aid in the understanding of the pathophysiology of Ebola-associated eye disease. Study Population: Up to 60 Ebola survivors and up to 60 controls will be enrolled. The accrual ceiling is 120 participants. Design: This is a prospective, natural history study to evaluate the persistence of Ebola viral RNA in the eyes of Ebola survivors and assess the response to cataract surgery in survivors as compared to controls. EVD survivors will first undergo assessment of aqueous humor for the presence of viral RNA. Survivors testing negative for viral RNA and control subjects will undergo clinically indicated cataract surgery. Subjects will be evaluated 1 day, 1 week, 1 month, and 3 months after surgery for safety and visual outcome assessments, and more often as clinically indicated. Outcome Measures: The primary outcomes are: 1) the proportion of EVD survivors with evidence of persistence of Ebola viral RNA in ocular tissue and 2) the comparison of amount of intraocular inflammation, as measured by average grade of anterior chamber cell by SUN criteria, between EVD survivors and controls at 1 month and 3 months following cataract surgery. Secondary outcomes include: 1) the proportion of survivors with at least 20/40 best corrected visual acuity (BCVA) after cataract surgery, relative to controls; 2) significance of covariates, age and gender, in logistic regression assessment of viral persistence and cataract outcomes; 3) post-operative optical coherence tomography results in EVD survivors.

NCT ID: NCT03098862 Recruiting - Ebola Virus Disease Clinical Trials

PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response

Start date: October 25, 2017
Phase: N/A
Study type: Observational

Background: Genes are instructions that tell the body how to work and grow. They can affect how the body responds to infection. Researchers want to learn more about genes that affect how the body responds to the Ebola virus. Some people with Ebola get very sick and die. Others do not. The research may lead to better treatments for Ebola virus and other germs. Objective: To look for genes that may be related to a person s chance of getting very sick after coming in contact with the Ebola virus. Eligibility: People at least 3 years of age who either: Had Ebola Had close contact with someone who had Ebola Were in an Ebola vaccine study Design: Participants will have a small amount of blood taken from an arm vein by a needle. Researchers will collect participants data from other vaccine studies they may have been in. Participants may be asked questions about their health and social history. Some participants will have their blood tested for the infection syphilis and HIV, the virus that causes AIDS. Participants will be told the results and will get help finding care, if necessary. Some participants will have their blood sample tested to see if they have had Ebola in the past. Blood samples will be stored for future research. They will be marked with a code but not with participants names.

NCT ID: NCT02876328 Recruiting - Ebola Virus Disease Clinical Trials

Partnership for Research on Ebola VACcinations

PREVAC
Start date: March 31, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVĪ”G-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.

NCT ID: NCT02852291 Active, not recruiting - Parenting Clinical Trials

Parents Make the Difference II: Trial of a Parenting Intervention

Start date: March 2016
Phase: N/A
Study type: Interventional

Multisite randomized trial of a parenting intervention in Liberia for caregivers of young children. Two main objectives of the "Parents Make the Difference" program are to teach parents (a) skills for decreasing harsh punishments and replacing those with positive ways to manage children's behavior and (b) skills for having more positive interactions with their children, including interactions that encourage learning. As a result of positive changes in parenting, the investigators expect that, over time, children's behavioral and cognitive well-being will improve and that future abuse and poor developmental outcomes will be prevented in the long-term.

NCT ID: NCT02818582 Recruiting - Clinical trials for Persistent Ebola Virus

GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

Start date: June 28, 2016
Phase: Phase 2
Study type: Interventional

Background: Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. There are currently no drugs for people who have survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734, might help get rid of Ebola virus in semen. Objective: To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans. Eligibility: Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola virus in their semen Design: Participants will be screened with: Questions Physical exam Eye exam Blood tests 2 semen samples if they have not had it tested recently Participants must live near the study site in Liberia for 6 months. Participants will be put into 1 of 2 study groups. They will have an infusion of either GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The infusion lasts 1 hour. Participants will be observed for 1 hour after. They will provide a semen sample on infusion day 4. After the infusions, participants will have 5 visits in the first month, then 1 per month for 5 more months. These include giving a blood and semen sample. Blood tests are performed before and after each infusion and the last visit (5 month visit) will also include an eye exam. When the study is over, if the study drug works and is safe, participants who got the placebo can get the study drug.

NCT ID: NCT02448745 Enrolling by invitation - Anemia Clinical Trials

Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)

Start date: January 2014
Phase: N/A
Study type: Interventional

A cluster-randomized control trial will study the effect of insecticide-treated wall lining on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study will receive insecticide-treated wall lining covering their walls and ceilings in addition to long-lasting insecticidal nets, while the other half will be protected by existing long-lasting insecticidal nets.

NCT ID: NCT02431923 Recruiting - Ebola Virus Disease Clinical Trials

Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up

Start date: April 30, 2015
Phase: N/A
Study type: Observational

Background: - Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects. Researchers want to learn what ill health conditions Ebola survivors have. They want to learn if Ebola survivors can infect others in their household through close contact. They also want to learn if Ebola survivors are immune from getting Ebola again. To learn these things, they want to follow people in Liberia for 5 years. Objectives: - To learn how Ebola affects the health of survivors and the people they live with. Eligibility: - People in Liberia who had Ebola in the past 2 years, who share a household with someone who had Ebola, or who got ill and went to an Ebola Treatment Unit but were sent home because they did not have Ebola. Design: - Participants will be screened with family illness history, physical exam, and blood tests. They may have an eye exam. - Ebola survivors and those who went to a Treatment Unit but did not have Ebola will visit a clinic at 3, 6, and 12 months, then every 6 months for 5 years. At each visit, they will repeat the screening tests. - Participants who live with someone who had Ebola will have only the screening visit. But they may be asked to return for follow-up visits. These visits will help researchers learn more about the differences between those who have had Ebola and those who have not. - Participants brought to the NIH Clinical Center will have documentation of positive Ebola virus PCR and a clinical syndrome compatible with acute EVD. - The study will last 5 years.

NCT ID: NCT02363322 Active, not recruiting - Clinical trials for Ebola Virus Infection

Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection

Start date: February 13, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Ebola is a viral infection that can spread quickly and causes life-threatening disease. Right now there is an Ebola outbreak in many countries in West Africa. There are no approved treatments for Ebola. But possible treatments are being developed. Researchers need to study these treatments to see if they help people get better. Objective: - To identify possible Ebola treatments. Also, to learn if adding 1 or more experimental drugs to advanced Ebola care can reduce the risk of death. Eligibility: - People who have recently been diagnosed with Ebola, usually by a test called the Polymerase Chain Reaction (PCR), and have been hospitalized in an isolation unit for treatment. Design: - Participants will be randomly assigned to Group A or B. Both groups will get advanced level care. One group will also get an experimental drug. - Participants may have blood tests. They may have another PCR test. - Researchers will try to learn how the participant got Ebola. - Participants put in the experimental drug group may start taking medicine within 24 hours of enrollment. It may be given by mouth or intravenously. Additional doses may be needed. - Participants may have a series of timed blood tests over the first 24 to 48 hours after they take the medicine. - Blood will be drawn frequently. Other body fluids (urine, stool, vaginal fluid, etc.) may also be collected. - Participants will be followed for up to 60 days. They may be evaluated for any long-term effects of the experimental treatment(s). They may be asked to return for 1 or more outpatient visits. - For consenting participants, follow-up will be extended for up to one full year past Day 58 with contact/visits every 1-3 months to assess for a history of signs or symptoms potentially consistent with late onset of virologic relapse syndrome.

NCT ID: NCT02344407 Active, not recruiting - Ebola Virus Clinical Trials

Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)

Start date: January 20, 2015
Phase: Phase 2
Study type: Interventional

Background: - Ebola virus disease (EVD) affects many people in Liberia and other countries in West Africa. It is caused by the Ebola virus and makes people sick with fever, headache, vomiting, diarrhea, rash, and bleeding. About half the people with EVD die. There is no approved treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not cause Ebola. Objectives: - To study the safety and efficacy of two Ebola vaccines. Eligibility: - Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never had Ebola. Design: - Participants will give information including birthdate, gender, occupation, and location of home. They will give contact information for themselves and 2 alternate contacts. They will give a history of their contact with people with Ebola. Some participants may have a physical. They may have blood taken. - Participants will be injected with either an Ebola vaccine or a placebo with a needle in the upper arm. The placebo is a salt solution. - Participants will have blood taken. - Participants will be watched for 30 minutes. - Participants will return to the clinic 1 week and 1 month after they get the shot. They will have blood taken. - After that, participants will be contacted monthly to discuss how they are feeling. They may be contacted by phone, may visit the clinic, or may have a home visit. - The study ends 8-12 months after participants get the shot. If one of the vaccines works against Ebola and does not have many side effects, participants can get the vaccine if they did not get it in the study.

NCT ID: NCT02333578 Recruiting - Ebola Virus Disease Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of Convalescent Plasma for Ebola Treatment

EVD001
Start date: November 2014
Phase: N/A
Study type: Interventional

A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease (EVD) Convalescent Plasma (ECP) for treatment of EVD.