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Home
  • About
      1. Board of Directors
      2. Our Staff
      3. Annual Reports
      4. Policies
      5. Fellowship
      6. Careers
  • Projects
      1. Column 1
        1. Advancing Regulatory Science
          1. Oncology Multi-Regional Clinical Trials
          2. Rare Disease Innovation Roundtable
        2. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Cross-Sectoral Health Threats
          3. Industry SWOT Analysis
        3. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        4. FDA Patient Listening Sessions
      2. Column 2
        1. Food & Nutrition
          1. About
          2. Food Traceability
          3. Healthy Rule Roundtables
          4. Nutrition Facts Label
          5. Produce Safety Stakeholder Dialogue
          6. Retail Dietitian Toolkit
        2. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        3. Research
          1. About
          2. IMEDS
          3. Post Market Research
          4. RAISE
          5. Real World Data
          6. Regulatory Science Accelerator
      3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. Events
      3. News
      4. Publications
      5. 2026 Annual Public Meeting
  • Expanded Access eRequest
  1. Home

Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.

The information provided here is drawn from ClinicalTrials.gov.

Emergency INDs

To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.

Search Tips

To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.

Displaying 490 of 530

International AIDS Vaccine Initiative

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core)

Conditions: HIV

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety andImmunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNAVaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health

International Vaccine Institute

Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines

Conditions: COVID19

This is an observer-blind, randomized study which aims to assess the immune response andthe safety of two different approved vaccines for first and second dose in healthyadults.

Assiut University

Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease

Conditions: COVID-19

To measure the frequency of persistent liver dysfunction (raised liver enzymes, serumalbumin, prothrombin time, etc) in recovered COVID -19 patients.To compare the hepatic manifestations in post COVID -19 patients with and without liverdisease

Saglik Bilimleri Universitesi

PAI-1 Levels and Predicting Covid-19 Patients' Prognosis

Conditions: Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab, Symptomatic Covid -19 Positive Patients Who Require Hospitalization, Patients Who Did Not Vaccinate Against Covid-19, Patients Among 20 to 90 Years of Age, Healthy Control Patients of the Same Age

The primary aim of our study is to understand the effects of Covid-19 disease on vascularinflammation and coagulation cascade, and secondarily, to investigate its utility inpredicting disease prognosis by analyzing serum PAI-1 levels in patients with differentseverity. The study is planned as a prospective, cross-sectional study that will includepatients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. Atotal of 80 volunteers will be enrolled in the trial whose age, gender, and BMI areplanned to be matched.The study will be conducted on four groups. Group 1 (n=20; withmild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severesymptoms) and Group 4 (n=20; Control group).All participants who accepted the study will have their sociodemographic data, medicalhistory, and vital signs (respiratory rate, saturation, temperature, and blood pressurevalues) recorded at the start of the study. The pulmonologist in the study will alsoclassify the patient group's chest X-ray and chest tomography findings and the thymusgland dimensions. After all four groups of patients have given their consent for thestudy, a sample of 5cc blood will be obtained once for the PAI-1 analysis.

Biogipuzkoa Health Research Institute

Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19

Conditions: Covid-19 Infection

EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with twobranches. Patients who meet all the inclusion criteria and none of the exclusion criteriawill be randomized 1: 1 to be included in one of the following groups: - Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19. - Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.

Universita di Verona

RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic

Conditions: Psychological Distress

This randomized controlled trial will evaluate the implementation and(cost-)effectiveness of the culturally and contextually adapted Doing What Matters intimes of stress (DWM) and Problem Management Plus (PM+) stepped-care programs amongstasylum seekers, refugees, and/or migrants living in Italy. Outcomes include mentalhealth, resilience, wellbeing, health inequalities, and costs to health systems.

Universidad del Desarrollo

Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster

Conditions: COVID19

Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies againstSARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data alsoindicate that vaccine effectiveness against Covid-19 wanes over time. Thus, theinvestigators aimed to determine the reactogenicity, safety, and immunogenicity of ahomologous or heterologous booster of SARS-CoV-2 vaccines among people already immunizedwith an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population andhealthcare workers.

Vastra Gotaland Region

COVID-19 Antibody Responses in Cystic Fibrosis

Conditions: Cystic Fibrosis, COVID19

Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resultedin an ongoing global pandemic. It is unclear whether the relatively low number ofreported cases of COVID-19 in people with CF (pwCF) is due to enhanced infectionprevention practices or whether pwCF have protective genetic/immune factors. This studyaims to prospectively assess the proportion of pwCF, including both adults and childrenwith CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This studywill also examine whether pwCF who have antibodies for SARS-CoV-2 have a differentclinical presentation and what impact this has on their CF disease. The proposed studywill recruit pwCF from paediatric and adult CF centres in Europe. Serological testing todetect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24with additional time-points if bloodwork is available via normal clinical care. Clinicaldata on, lung function, CF-related medical history, pulmonary exacerbations, antibioticuse, and microbiology and vaccination receipt, will be collected during routine clinicalassessments.Associations will be examined between socio-demographic and clinical variables andserologic testing. We will also examine the effects of SARS-CoV-2 infection on clinicaloutcomes and analyse end-points to explore any age-related or gender-based differences,as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receivingCFTR modulator therapies. As pwCF receive COVID-19 vaccination we will perform acomparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCFfollowing natural infection and vaccination SARS-CoV-2 over time.

National Institute of Mental Health (NIMH)

A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx

Conditions: Parenting, COVID19

For caregivers in the Bronx, the pandemic has caused unprecedented psychologicaldistress; in addition to combating social determinants of health (SDOH), these familiesnow face greater financial insecurity and challenges related to their school-agedchildren. Furthermore, social distancing requirements and limited telehealth resourcesfor Bronx families have posed greater barriers to healthcare. Such parental distresscontributes to heightened risk of transgenerational cycles of psychological stress,trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic havehad significant consequences for family well-being, putting parents at higher risk ofexperiencing distress and potentially impairing their ability to provide supportive careto their children. Although children may be less susceptible to the most damagingphysical consequences of COVID-19, there are growing concerns regarding the short-andlong-term impacts of pandemic-related stressors on children. The marked upheaval offamily life over an extended period may make children vulnerable to mental healthconsequences associated with the public health crisis and infection mitigation efforts.School and childcare closures, unstable financial circumstances, social isolation andlack of support have a disproportionate, cumulative impact on parents and may underminetheir capacities to provide support for their children. Importantly, a large body ofevidence suggests that parental stress during times of disasters inducespsychopathologies in family members including children. Further, high anxiety anddepressive symptoms in parents during the pandemic have been associated with higher childabuse potential, whereas greater parental support was associated with lower perceivedstress and child abuse potential. In addition to psychological impacts, stress associatedwith caregiving can interfere with parents' ability to maintain their own health. Thismultimodal study addresses key strategies to mitigate the psychological and health impactof COVID-19 in parents.

Chinese University of Hong Kong

Impact of COVID-19 Vaccines on Cerebrovascular Health

Conditions: Stroke, Stroke, Acute, Stroke, Ischemic, Dementia, Brain Ischemia, Alzheimer Disease, Brain Diseases, Major Adverse Cardiovascular Event, Arterial Thromboembolism, Venous Thromboembolism

Safe and effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinesmay reduce the transmission of and achieve population immunity against the COVID-19pandemic, which accounted for more than 3.75million deaths worldwide. With World HealthOrganization's (WHO) effort on ensuring equitable access to COVID-19 vaccines,vaccination rate may increase in the near future.On the other hand, vaccination hesitancy has emerged as a major hindrance on the globalvaccination campaigns in certain areas due to safety concerns, social factors, and publichealth policies. For instance, a recent survey conducted in Hong Kong showed a lowvaccine acceptance rate of 37%. Long-term safety concerns and post-vaccination eventsrelayed by the social media maybe reasons for vaccination hesitancy. Among which,cerebrovascular accidents (CVA) after vaccination were one of the most frequentlyreported post-vaccination events. These reports ranged from ischemic strokes in elderlypatients with multiple cardiovascular co-morbidities, to hemorrhage strokes in otherwise"young-and-fit" adults. While many of these events were investigated by the COVID-19immunization expert committee, an important premise to address the apprehension of CVAafter vaccination is the provision of evidence-based information of the impact ofCOVID-19 vaccines on brain health.In this prospective, longitudinal, observational study, we aim to elucidate therelationship between COVID-19 vaccines and cerebrovascular health in healthy citizens ina population-based cohort.

Pagination

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Status

  • Unknown status (254)
  • Recruiting (129)
  • Active, not recruiting (116)
  • Enrolling by invitation (14)
  • Not yet recruiting (11)
  • Approved for marketing (3)
  • Available (3)

Intervention Type

  • Other (159)
  • Drug (134)
  • Biological (75)
  • Diagnostic Test (51)
  • Behavioral (24)
  • Device (16)
  • Procedure (11)
  • Dietary Supplement (8)
  • Radiation (7)
  • Combination Product (5)
  • Genetic (1)

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© Reagan-Udall Foundation for the FDA