Clinical Research Directory

Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study

CIRV2 is a Phase IV randomized, open-label, trial of FDA-approved COVID-19 and/or influenza vaccines (no more than minimal risk) with longitudinal follow-up. In 2026 CIRV2 will compare immunogenicity and reactogenicity of the recombinant Novavax COVID-19 vaccine and the mRNA Pfizer-BioNTech COVID-19 vaccine.

Dapagliflozin for Long COVID Syndrome

This is a randomized, placebo-controlled study. Patients with long COVID will be randomized to receive dapagliflozin or placebo for 12 months.

Assessment of Stress and Associated Factors Among Young Adults During the COVID-19 Pandemic

Since the onset of COVID-19, studies conducted on the general population have shown an increase in the use of antidepressants and anxiolytics, a rise in domestic violence, and heightened demand for peri-urban housing offering more space and a better living environment. Queues of students at food distribution points, along with the precarious situations and isolation faced by students with no alternative to cramped living quarters, have exposed the vulnerability of this population to the general public. There is a lack of data regarding young people-and students in particular-a group known to be at higher risk than others of exhibiting symptoms of stress, anxiety, or depression. Depression among students and young adults can impact their social lives, relationships, and quality of life. Indeed, studies have demonstrated a strong correlation between major depressive disorder and poor academic performance, unstable interpersonal relationships, suicidal thoughts and attempts, and difficulties with work. Existing literature indicates a link between stress and the onset or persistence of anxiety and depression. As these conditions are too often conflated, it is important to distinguish stress from anxiety and depression. Consequently, a study designed to assess levels of stress, anxiety, and depression-as well as the processes involved in their development and persistence among young people-would facilitate the implementation of appropriate and effective care. Such a study is all the more necessary in the current context of the COVID-19 pandemic. Identifying these disorders within specific populations and subgroups would enable the implementation of tailored care strategies, thereby helping to safeguard mental health. The aim of this study is to assess current levels of stress, anxiety, and depression among young adults and students, and to investigate the underlying determinants.

Effect of Surgical Masks in Preventing Acute Respiratory Infections

The goal of this clinical trial is to evaluate the efficacy of surgical masks in preventing acute respiratory tract infections. The main question it aims to answer is: \- Does wearing a mask prevent you from getting acute respiratory tract infections, including influenza and COVID-19 Researchers will compare a surgical mask to no intervention to see if wearing a mask works to prevent acute respiratory infection. Participants will: * Wear or not wear a surgical mask every day * Answer a questionnaire every 2 weeks on symptoms, testing status, and behaviors This trial does not assess if wearing a mask prevents transmission of pathogens when you are already sick. Also, the trial does not assess whether universal masking (where everyone wears masks) works.

RSV, Influenza, and SARS-CoV-2 Outcomes in Severely Immunosuppressed Adults

Respiratory syncytial virus (RSV), influenza, and SARS-CoV-2 are common respiratory viruses. In healthy adults they usually cause mild, cold-like illness, but in people whose immune system is severely weakened - such as people who have had a bone marrow, stem cell, or organ transplant, people being treated for cancer or blood disorders, or people taking medicines that suppress the immune system - these infections can be much more serious, sometimes spreading from the nose and throat down into the lungs and leading to hospitalization, intensive care, or death. This study looks back at medical records from a large hospital network in Buenos Aires, Argentina, covering two periods (November 2011 to March 2020, and May 2022 to December 31, 2025) to describe what happens to adults with severely weakened immune systems after they are diagnosed with RSV, influenza, or SARS-CoV-2. For each of these three viruses, researchers will separately describe how sick patients were on the day of diagnosis and again 7 and 30 days later; whether the infection spread from the upper airway down into the lungs; how often patients needed to be hospitalized or admitted to an intensive care unit; how long hospital stays lasted; and how many patients died within 30 days. The study will also look for patient characteristics - such as the type of immune weakness, low blood cell counts, or vaccination status - that are linked to worse outcomes within each virus group. The three viruses are described separately and are not statistically compared against one another. This is a review of existing medical record information only. No new tests, procedures, or treatments will be given to patients as part of the study, and no patient will be contacted; all information comes from data already collected during routine medical care. This study is conducted under a research agreement with Pfizer.

Surveillance, Assessment and Detection of Influenza Associated Respiratory Infections in HIV Positive and Negative Individual in Lusaka, Zambia.

Background and rationale:The World Health Organisation (WHO), estimates influenza global deaths at 290,000 to 650,000 annually. Although influenza is mostly associated with upper respiratory tract infections (URTIs), its role in lower respiratory tract infections (LRTIs) and the associated poor clinical outcomes have been overlooked in sub-Saharan Africa. A study conducted in eight SSA countries estimated that 8.2% of cases and 2.8% of deaths from LRTIs were due to primary infection with influenza. Pneumonia and influenza-associated illness are responsible for 8.5% of respiratory deaths in Zambia. However, in routine practice, testing to distinguish between bacterial and viral etiology of RTIs is seldom done outside sentinel surveillance due to the high cost and lack of available testing options. This consequently underestimates viral RTIs in the population. It is particularly important to diagnose flu early on in vulnerable populations so that they receive timely and appropriate medical care. Although Zambia is a high HIV burden country with a prevalence of 11%, there is presently no study that has described the burden of influenza in the HIV positive population. This research study will address gaps in current scientific knowledge, providing key insights about the prevalence, circulating types, seasonality and associated clinical outcomes of influenza, RSV and SARS-CoV-2 infection in Zambia in the post COVID-19 era. Objectives Primary To determine the prevalence of influenza (A and/or B) infections in a high HIV burden setting in Lusaka, Zambia over one or more influenza seasons. Secondary 1. To determine the prevalence of influenza co-infection with RSV and/or SARS-CoV-2 2. To determine the clinical outcomes of influenza (A and/or B) infection among Zambian adults, with and without co-infection with RSV and COVID-19, by HIV and COVID-19 vaccination status. 3. To evaluate the accuracy and yield of aerosol-based sampling for diagnosis of respiratory viruses (influenza, SARS-CoV-2, and RSV) compared to nasal/ nasopharyngeal swabs, for rapid diagnosis of infection among symptomatic individuals in Zambia. 4. To evaluate the acceptability of exhaled breath aerosol (XBA) sampling for diagnosis and screening of respiratory infections of pandemic potential. Study design and participants: Primary objective and secondary objective 1: Cross sectional surveillance study of individuals presenting with flu-like symptoms at two first level hospitals in Lusaka, Zambia. Recruitment of 594 participants will be done over the study period and participants will include both males and females presenting with 2-7 days of flu-like symptoms, able to provide informed consent, aged ≥18 years, with a known HIV status or willing to be tested, with a known COVID 19 vaccination status and available for symptom follow-up. Secondary objective 2: Prospective follow up of participants enrolled in aim 1 for 14 days will be done to document clinical symptom progression and outcomes. Appropriate care will be provided to all participants within routine care services. Secondary objective 3 \& 4: Mixed methods approach. All patients enrolled under aim 1 will be requested to provide in addition to the routine nasopharyngeal sample, an aerosol-based sample for diagnostic accuracy and yield evaluation. We will also conduct an investigator-administered questionnaire to ascertain end-user experience and preferences for either sampling method. Location Zambia (Kanyama and Chawama sub-districts) Duration April 2025 to November 2026 (Participant enrolment duration)

Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France

Every year in the fall and winter, numerous respiratory viruses (such as influenza viruses, SARS-CoV-2 (COVID-19), RSV, rhinovirus, and metapneumovirus) circulate in mainland France, causing acute respiratory infections (ARIs). These viruses can cause epidemics of varying severity, requiring close monitoring to determine their circulation levels and adapt public health measures accordingly. In France, ARI surveillance relies on two networks: the Sentinelles network in primary care and the RENAL network in hospitals. The Sentinelles surveillance is conducted in collaboration with Santé publique France, the National Reference Center for Respiratory Infection Viruses (Institut Pasteur and Hospices Civils de Lyon), and the University of Corsica. As part of the virological surveillance of ARIs, Sentinelles physicians are asked to collect nasopharyngeal swabs or saliva samples from a sample of patients presenting with an ARI during their clinic visits. This surveillance makes it possible to identify respiratory viruses circulating in primary care (general practice and pediatrics), to describe confirmed cases for each of the circulating viruses, and to estimate the impact of each on general practice. This surveillance also allows for the evaluation of the effectiveness of vaccines against influenza and COVID-19.

A Phase 1 Study to Evaluate the Safety and Immunogenicity of GC4006A in Healthy Adults

A Phase 1, Randomized, Double-blind, Dose-Escalation, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Preventive Vaccine 'GC4006A' in Healthy Adults Aged 19 to 64 Years

Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19

This is a Phase 1a, single-country, single-centre, single-blinded, COV2 vaccine formulation randomized trial designed to investigate and compare the safety and immunogenicity of two COV2 vaccine formulations. COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2 spike protein. Participants will receive one of the two COV2 formulations in two doses on Day 0 and Day 28. This trial consists of two parts; Part 1 is a vaccination phase assessing safety and immunogenicity and Part 2 is a long-term immunogenicity follow-up assessing persistence of immune response.

The Efficacy of Long-Chain Fatty Acids, Eicosapentaenoic Acid (EPA) and Specialized Pro-Resolving Mediators (SPMs), in Treating Long COVID Neuropsychiatric Symptoms

Researchers conducted a 12-week, double-blind, randomized, placebo-controlled trial to assess the effectiveness of EPA or SPM treatments versus a placebo in managing Long COVID symptoms in adult patients. Researchers planned to enroll 240 eligible participants from various general and psychiatric hospitals in Taiwan. The focus was on evaluating the therapeutic impact and potential side effects of administering 3 g/day of EPA or 1.67 mg/day of SPMs on symptoms of depression in these patients. This consolidated approach aims to provide comprehensive insights into the efficacy of EPA and SPM treatments in Long COVID cases, addressing crucial mental health aspects.

Cohort Study of Intraoperative Lung Protective Ventilation Trends in a Large Canadian Health Authority

The goal of this observational study is to ascertain the practice patterns and predictors in performing lung protective ventilation as per clinical guidelines for adult patients undergoing non-cardiac surgery in Fraser Health Authority, a large Canadian authority in the lower mainland of British Columbia, Canada. In particular, the investigators explore changes before/after the COVID-19 pandemic. The main questions it aims to answer are: * In this population, what is the general compliance rate to lung protective ventilation * In this population, what are the predictors of compliance before/after the COVID-19 pandemic. This is a retrospective study using linked patient data from two databases in the health region: the anesthesia informational management system for intraoperative data, and the electronic medical record for perioperative data. Rationale for study: Breathing problems after surgery affect 5% to 33% of patients and can lead to serious issues like lung infections, breathing failure, and longer hospital stays, with up to a 20% risk of death within 30 days for serious cases. A proven way to reduce these risks is lung protective ventilation (LPV), a technique used during surgery where the ventilator delivers smaller breaths based on clinical guidelines and calculated using a person's ideal body weight, while applying gentle pressure to keep the lungs slightly open. While this approach has been widely adopted in intensive care units over the past 20 years, it's less commonly used in operating rooms, with fewer than half of surgeries using it. Barriers include suboptimal default ventilator settings, patients at extremes of weight, and misunderstandings of LPV among clinicians. During the COVID-19 pandemic, LPV use increased for patients with COVID-related lung problems, showing improved survival rates in ICUs. However, it's unclear if this practice carried over to surgical patients at-large or continued after the pandemic. Most studies on LPV during surgery have been conducted outside Canada, where healthcare practices and education may differ from within Canada. To address these gaps, the investigators aim to study LPV use during surgery in a large Canadian health system, identify factors that influence its use, and examine trends during and after the COVID pandemic. This research will help improve patient care by promoting the use of this effective technique in Canadian operating rooms.

Retail COVID-19 Study

Despite the availability of vaccines, there remains a need to identify specific immune responses that correlate with protection against SARS-CoV-2 infection. Additionally, the operational capability of retail pharmacy infrastructure to collect longitudinal data and biological samples needs to be assessed. This study aims to fill these gaps by determining correlates of protection (CoP), assessing the infrastructure's capability, and examining demographic and geographic differences in participation.

Development of Preterm Infants Born During the COVID-19 Pandemic

This study aims to evaluate differences in cognitive and psychomotor development among preterm infants (born before 34 weeks of gestation) delivered during the COVID-19 pandemic at Hospital de la Santa Creu i Sant Pau, compared with a control group of preterm infants born at the same hospital.

Effect of Pulmonary Rehabilitation and Physical Activity on COVID-19 Long-Term Symptoms (PuReCOVID)

This single-center, observational, longitudinal, retrospective and prospective study investigates the impact of Active Cycle of Breathing Technique (ACBT) and moderate daily physical activity on symptoms associated with long COVID, such as cough, dyspnea, and fatigue. The study aims to assess whether these interventions can moderately alleviate or resolve these symptoms and evaluate their potential association with small airway dysfunction (SAD), as measured by Impulse Oscillometry (IOS). The investigators will recruit 40 adult patients with long COVID who meet specific inclusion criteria. Participants will perform ACBT twice daily and complete at least 6000 steps per day for six weeks. The investigators will track clinical and lung function parameters, including spirometry, IOS, and exercise capacity.

PA-001 Ph.1 Study in Healthy and Elderly Subjects

This was a double blind, randomized, placebo controlled, single and multiple IV dose study conducted in 2 parts, single ascending dose and multiple ascending doses parts. The principal aim of this study was to obtain safety and tolerability data when PA-001 is administered IV as single and multiple doses to healthy subjects. This information, together with the PK data, will help establish the doses and dosing regimen suitable for future studies in patients. The study also investigated the effects of age on the PK of PA-001 prior to patient studies.

Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19

This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19. It will also learn about the safety of drug Ratutrelvir. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.

Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays. The main questions it aims to answer are: * Efficacy, * Safety, * Usage, * Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies. The 4 medical devices under investigation will be used in accordance with their intended use, target populations and medical indications.

Autoantibodies Against Type I Interferon in Patients Affected With Ph-negative Myeloproliferative Neoplasms (MPN-IFN Study)

The classic Ph-negative myeloproliferative neoplasms (MPN) are a group of clonal hematopoietic disorders caused by a dysregulated JAK/STAT signal transduction because of acquired somatic mutations of JAK2, CALR or MPL genes. Chronic inflammation may predispose to MPN development. SARS-CoV-2 infection displays extreme interindividual clinical variability, ranging from asymptomatic infection to life-threatening coronavirus disease (COVID-19). Age is a major risk factor for severe disease. Male sex and medical comorbidities have minor impact. It was demonstrated that at least 3.5% of patients with life-threatening COVID-19 have monogenic inborn errors of TLR3- or TLR7-dependent type I interferons (IFN-I) immunity. It has also been described that at least 15% of patients with life-threatening COVID-19 have neutralizing autoantibodies (AAbs) against IFN-I, that precede SARS-CoV-2 infection. As regard MPN, COVID-19 is associated with a mortality as high as 33%. Patients with MF had the highest mortality (48%), while patients with ET had the greatest risk of venous thromboembolism (16.7%). In this prospective study, we want to search for AAbs against IFN-I in a cohort of MPN patients to evaluate their prevalence in the MPN population and to look for clinical correlations, including COVID-19 severity.

Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients

Since the start of the COVID-19 pandemic, the approach to solid organ transplantation has evolved. Transplants using organs (excluding lungs) from COVID-19-positive donors have shown short-term safety, but there is limited data on recipients who are SARS-CoV-2 positive. Currently, kidney transplants in such recipients are delayed until symptoms resolve and a negative PCR is preferred, despite the risks of prolonged dialysis and increased cold ischemia time. Recent data from the Omicron era suggest that early antiviral treatment may reduce complications. Immunosuppressive therapy might even help mitigate severe inflammatory responses. The proposed study aims to show that kidney transplantation can be safely performed in asymptomatic or mildly symptomatic COVID-19-positive recipients who begin antiviral treatment (remdesivir) within 24 hours before transplant and continue for 10 days. This could reduce waiting times and improve outcomes. Remdesivir is an antiviral safe for use in patients with low kidney function, including those on dialysis or post-transplant, with minimal side effects. The hypothesis is that this treatment strategy can prevent progression to severe COVID-19 and allow safe transplantation

Impact of Covid-19 on Syphilis

Sexually transmitted infections (STIs) represent a significant challenge to global public health. Although many of these infections are treatable, failure to diagnose and delayed treatment can lead to serious complications, including infertility, chronic inflammatory diseases, and an increased risk of HIV transmission. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022.

Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant

The goal of this clinical trial is to learn if the SARS-CoV-2 subunit mucosal vaccine with the recombinant flagellin protein adjuvant works to Prevent COVID-19 infection. It will also learn about the Safety and immunogenicity of the vaccine.