Clinical Research Directory

Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)

Background: Loss of the sense of smell can seriously affect a person's quality of life. The ability to smell can be damaged by many factors, including illnesses, injuries, and exposure to toxic chemicals. The effects can vary, including complete loss of smell, partial loss, and parosomia, which is when things smell differently than they should. Objective: To study how brain function changes in people with different types of smell disorders. Also, to look at how smell loss affects quality of life over time. Eligibility: People aged 18 years or older with a disorder that affects their sense of smell. Healthy volunteers are also needed. Design: Participants will have 5 study visits over 1 year. They will have various tests and procedures: Smell tests. They will have several tests that involve smelling different items and answering questions. Questionnaires. They will answer questions about their health, mood, sense of smell, and daily habits. Magnetic resonance imaging (MRI) scans. They will lie on a bed that slides into a tube. Padding will hold their head still. They will smell different odors while in the scanner. Electrobulbogram (EBG). They will wear a soft cap with sensors that measure brain activity. They will smell different odors while wearing the cap. Nasal endoscopy. A flexible tube will be inserted into a nostril to view the inside of the nose. Biopsy. A numbing substance will be sprayed into the nose. Then a scissor-like tool will be used to collect a sample of tissue from one or both nasal passages. Samples of blood, urine, and nasal fluid will be taken.

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults

The purpose of this trial is to evaluate immunogenicity and safety of CVXGA administered as a single intranasal dose against SARS-CoV-2 S-protein in participants. The trial will enroll up to 400 healthy participants, age 18-80 years.

A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults

This phase 1 randomized, open-label, dose-escalation clinical trial evaluates the safety and immunogenicity of OCU500, a ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine, in healthy adults aged 18-64 who previously completed a primary COVID-19 vaccination series and at least one booster. The study evaluates two dose levels (1×10\^10 viral particles (VP) and 5×10\^10 VP) and two routes of administration (intranasal and inhaled). The trial includes 80 participants across four study arms (20 per arm). The primary objective is to evaluate the safety and reactogenicity of a single dose of OCU500 administered in previously vaccinated healthy adults.

A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults

The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. The trial will enroll up to 434 healthy participants.

Secondary Databased Post-marketing Surveillance Study of BNT162b2

This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.

A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans

Background: The immune response is how the body recognizes and defends itself against foreign and harmful substances. Researchers want to compare the immune responses between young and older healthy adults after they receive vaccine doses for COVID-19. This research may help to determine whether age impacts cell response to COVID-19 vaccines. Objective: To study the immune response of people who receive Pizer or Moderna COVID-19 vaccines. Eligibility: People aged 18 and older who have not had COVID-19 and who either plan to receive the first dose of a COVID-19 vaccine within the next month or have received at least the first of 2 doses of the vaccine within the last 6 months. Design: Participants will be screened by telephone. Participants will not get the COVID-19 vaccine in this study. They must get it through a vaccine location. Participants who have not yet been vaccinated will have 7 visits. The first 4 visits will occur in the first month before and after each vaccination. The last 3 visits will occur 6 months, 1 year, and 2 years after completed vaccination. Participants who have received at least 1 of 2 doses of the COVID-19 vaccine within the last 6 months will have 3 visits. The first visit will occur within 6 months of receiving the first vaccine dose. The last 2 visits will occur 1 year and 2 years after the first vaccine dose. At visits, participant will review their medical history. Their height, weight, and/or vital signs will be measured. They will give blood samples after fasting. They may give urine samples. They may have a nasal swab test for COVID-19.

Viral Infections in Healthy and Immunocompromised Hosts

Background: \- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development. Objectives: \- To collect samples and data from individuals who have been exposed to or have contracted viral infections. Eligibility: * Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases. * Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate. Design: * Participants will be pre-screened to determine if they meet the eligibility criteria for the trial. * If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies. * Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing. * Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection. * Treatment is not offered under this study.

Evaluation of the Safety and Efficacy of Autologous COVID-19 Antigen Specific T Cell in Prolonged SARS-CoV-2 Patients

The goal of this clinical study is to evaluate the safety and efficacy of autologous COVID-19 antigen specific T cell (LB-DTK-COV19) treatment in prolonged SARS-CoV-2 infected patients. The main questions it aims to answer are: * What adverse events occur after the infusion of LB-DTK-COV19? * Is there a clinically significant improvement in clinical symptoms within 4 weeks after the infusion? * Is there a clinically significant reduction in SARS-CoV-2 viral load within 4 weeks after the infusion? The patients will: * Receive a single infusion of LB-DTK-COV19 either intravenously or using central venous catheter during the baseline visit at a dose of 1x10\^7/m\^2. * Receive a second infusion of LB-DTK-COV19 either intravenously or using central venous catheter at the same dose 14 days after the first infusion. * Attend follow-up visits at the clinic for 6 months after the first infusion.

COVID-19 Experiences in the SELF Cohort

Background: COVID-19 affected African Americans more than Whites. African Americans, especially women, have had higher rates of COVID-19 infections compared to Whites. They are also more likely to go to the hospital or die of this disease. Many researchers who looked into these issues lacked background data on the people they studied. SELF is a 10-year study of fibroids in African American women aged 23-35. Researchers already have a lot of data on these women. Asking how COVID-19 affected them can add context other studies lack. Objective: To describe the impact of the COVID-19 pandemic on young African American women and their families. Eligibility: Participants must be enrolled in SELF (Study of Environment, Lifestyle, and Fibroids). Design: Researchers will invite all women enrolled in SELF to participate in this natural history study. Participants will complete one questionnaire. They will answer the questions online. They may also choose to get a paper copy sent by mail. The survey will take no more than 15-20 minutes. All questions will relate to COVID-19. Participants will be asked if they had COVID-19. They will be asked if family, friends, or members of their community did. They will answer questions about their vaccine status and access to health care services. Participants will also answer questions about how the pandemic affected their lives. They will be asked about their job and if finding childcare was a challenge. They will be asked about money problems and how they coped. They will be asked about sleep problems and emotional distress. Participants will get a $30 gift card after they finish the survey. ...

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations

The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.

Smart Analysis and Decision-Making for Emerging Infectious Diseases

Emerging infectious diseases, such as COVID-19, mpox, and dengue fever, are characterized by rapid transmission, wide impact, and high uncertainty, posing ongoing threats to global public health. While China achieved significant success in COVID-19 control, the response also revealed key challenges, including fragmented information, delayed risk perception, experience-dependent assessment, and inefficiencies in complex decision-making. This study aims to establish a smart technology system covering the full chain of "risk perception-situational assessment-intelligent decision-making-comprehensive evaluation." Specific objectives include: Constructing a global disease burden database and knowledge graph for emerging infectious diseases; Developing early risk assessment models covering the full transmission spectrum (cross-species, imported, and local outbreak); Building an AI-driven collective intelligence decision-support tool for epidemic control; Developing precise intervention frameworks and comprehensive evaluation indicators for key populations (e.g., elderly, students); Integrating the above technologies into a multi-agent toolkit and evaluating its effectiveness through a cluster randomized controlled trial across 52 CDC sites in five provinces (Guangdong, Zhejiang, Hubei, Sichuan, and Shanghai). The study population includes public health professionals and managers responsible for epidemic surveillance, risk assessment, decision-making, and emergency response at the city/district/county CDC levels across the five provinces. Approximately 780 participants will be enrolled. The intervention group will use the smart toolkit alongside routine practices, while the control group will follow routine practices only. The primary outcome is response time for epidemic assessment and decision-making (hours from risk perception to decision completion). Secondary outcomes include epidemic control effectiveness, user satisfaction, and socioeconomic benefits. The intervention period is 3 months, starting around July 2026 and ending in December 2027. This study has been approved by the Peking University Biomedical Ethics Committee. The study does not involve individual patient data; all data are aggregated at the district/county level from CDC sources or publicly available data. Anonymous questionnaires do not collect any personal identifiable information.

The SINCERE Intervention to Address COVID-19 Health Disparities

The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic follow-up as a scalable strategy for preventing COVID-19 transmission, and for addressing the secondary health effects of the social, behavioral, and economic changes following the COVID-19 pandemic. With statewide community service providers, existing health information technology, and piloted methods, we seek to determine the effectiveness of universal social needs screening and community service referrals - the SINCERE intervention - in improving health outcomes of COVID-19 vulnerable and socioeconomically disadvantaged populations and whether intensive follow-up and collaborative goal-setting helps overcome barriers to community service use by patients seen in the emergency department and seeking COVID testing at community-based and mobile clinic locations.

Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System

The purpose of this pilot study is to measure the impact of non-invasive pneumatic manipulation of transthoracic pressure on oxygenation in patients with Acute Respiratory Distress Syndrome (ARDS) due to Coronavirus Disease 2019 (COVID 19) who are on mechanical ventilator support. This will be achieved by a pneumatic Vest placed around the chest wall of consenting patients who meet inclusion criteria. The Vest is essentially a non-invasive segmental device placed upon the anterior and posterior right and left aspects of the chest wall. The researchers have the ability to inflate and deflate the chambers of the Vest to achieve preset pressures as determined by the protocol and observe the patient's physiological response. Participants will have up to four hours of intervention with the study intervention, followed by 1 hour of post-intervention observation.

Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data

This study aims to use vaccination information from state vaccine registries linked with HealthVerity insurance claims for the following: * to measure how effective the Pfizer-BioNTech vaccine is at preventing post-COVID conditions. * to understand characteristics of patients who are receiving COVID-19 vaccines. All patients whose information is kept unidentified in the HealthVerity database are eligible to be included for both aims of this study.

A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir

Healthy adults will be enrolled into this open-label, Phase 1 research study. Participants will spend about 9 nights and 10 days in the clinical research unit (CRU) and the total time in the study will be about 11 weeks. The goal of this clinical trial is to compare how much of the study drug ibuzatrelvir is in participants' blood after taking one of the two different types of tablets containing the same amount of ibuzatrelvir without food. The study will also measure how much ibuzatrelvir is in participants' blood after taking one type of the tablets dispersed in water and when one type of the tablets is taken with food. This study drug is taken by mouth.

A Study to Learn How Paxlovid [Nirmatrelvir-ritonavir/PF-07321332] Works in COVID-19 Patients Who Are Elderly or Have Medical Conditions.

The purpose of this study is to learn about the effects of the study medicine called Paxlovid \[nirmatrelvir-ritonavir/PF-07321332\], for the potential treatment of COVID-19. This study will use patient health records in Ontario, to find people who were sick with COVID-19 and visited a pharmacist to be treated, anytime from December 1st, 2022, to March 31st, 2024. To be included in our study, the people must be over 18 years of age and be registered in the Ontario health system for at least one year. People were not included in our study if they have been pregnant in the past year or have serious kidney or liver disease. We will separate the people in the study into two groups: those who received treatment with Paxlovid \[nirmatrelvir-ritonavir/PF-07321332\] and those who received no treatment. We will monitor their healthcare visits or if they die for any reason, for up to 60 days after the date that they visited their pharmacist. Then we will compare participant experiences when they are taking the study medicine to when they are not. This will help us determine if the study medicine is effective.

Patient-Centered Practical Vaccine Talk For Busy Clinicians

The goal of this study is to assess the effect of an educational intervention for primary care providers (PCPs) on influenza and COVID-19 vaccine uptake among their adult patients through a pragmatic, cluster randomized trial in primary care clinics.

Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study

The current state of knowledge shows the presence of respiratory sequelae after acute infection with COVID-19 and the importance of these long-term respiratory dysfunctions have to be determined. Aim of our study is describe diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia at 3 and 6 months after the acute episode.

Safety, Reactogenicity, and Immunogenicity Trial of STX-S SARS-CoV-2 Vaccine in Adults

This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of STX-S in adults who have previously received a primary series and at least one booster with an authorized or licensed SARS-CoV-2 parenteral vaccine. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating three dose levels of STX-S. A sample size of 60 participants (20 participants per dose cohort) is anticipated. The primary objective is to evaluate the safety and reactogenicity of a single intramuscular injection of three different dose levels (25 ng, 50 ng, and 125 ng) of STX-S in previously vaccinated healthy adults

A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection

The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19). In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine.

Retrospective Study for Identificatiopn of a Link Between Doxycycline and COVID-19 Treatment

A new coronavirus, the third documented animal-to-human passage, emerged in Wuhan , China in the last quarter of 2019. Acne patients on doxycycline escaped seasonal viruses, showing the interest of this antibiotic as a possible treatment against COVID-19. The antiviral action of tetracyclines can be explained by different mechanisms. First of all, tetracyclines are modulators of innate immunity by decreasing NF-B expression, inhibiting inflammatory cytokines such as TNF-α, IL-1β and IL-6, inflammatory granulomas and free radical release . This action is obtained at doses lower than those necessary to obtain an antibiotic effect. Another possible action of tetracyclines is their ability to chelate zinc from matrix metalloproteinases (MMPS). The coronavirus family is known to bind to host MMPs, particularly for viral survival. Their chelating activity may help inhibit SARS-CoV-2 infection by limiting its ability to replicate in the host. Finally, tetracyclines could have a direct action by inhibiting the replication of single-stranded RNA virus, such as the SARS-CoV-2 coronavirus.We therefore propose a larger comparative study using data from the French National Health Data System.

Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms

Investigational New Drug trial investigating safety as primary endpoint and clinical efficacy as secondary endpoint of placental, mesenchymal stem cell-derived extracellular vesicles for the treatment of COVID-19 symptoms in adults with mild to moderate illness.

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of Boost-2867, given intramuscular (IM) with or without adjuvant or intranasal (IN) without adjuvant, as a booster dose to previously vaccinated healthy adults. Each of the study sites will be assigned to enroll either only participants who will receive IM administration (up to 5 sites) or only participants who will receive IN administration (up to 5 sites); no site will administer both IM and IN study product administrations. Within the IM and IN Arms the cohorts will be sequentially enrolled. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating one dose level of Boost-2867 without adjuvant administered IM, three dose levels of Boost-2867 with adjuvant administered IM, and three dose levels of Boost-2867 without adjuvant administered IN. A sample size of 140 participants (20 participants per dose cohort) is anticipated. To evaluate for early safety signals for this first-in-human trial, study product administration of participants enrolled for IM administration and those enrolled for IN administration will proceed in a staged fashion. For Cohorts 1 (IM administration without adjuvant) and 5 (IN administration), which may be enrolled and dosed concurrently, 3 sentinel participants under 50 years of age will be enrolled in each Cohort over at least 2 days. For each of those Cohorts independently, a safety review of halting rules and clinical safety data through at least Day 8 will be conducted by the Protocol Safety Review Team (PSRT) prior to enrollment of the remainder of the cohort. Enrollment, dosing, and safety oversight for IM Cohorts 2, 3, and 4 will proceed in the same fashion as Cohort 1, except that sentinel enrollment need not be spaced over at least 2 days. Similarly, for IN Cohorts 6 and 7, enrollment and safety oversight will proceed in the same fashion as Cohort 5, except that sentinel enrollment need not be spaced over at least 2 days. The primary objectives are: 1) To evaluate the safety and reactogenicity of a single IM injection of three different antigen dose levels (5, 15, and 50 microgram) of Boost-2867 with Alhydrogel (R) (alum) and CpG 7909 adjuvants, and a single injection of 50 microgram Boost-2867 without adjuvant, in previously vaccinated healthy adults. 2) To evaluate the safety and reactogenicity of a single IN administration of three different antigen dose levels (20, 50, and 125 microgram) of Boost-2867 without adjuvant in previously vaccinated healthy adults.

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.