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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 300 of 530

Ankara University

Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19

Conditions: COVID 19

COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus namedas SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have adevastating effect on many organs, the respiratory tract is particularly affected. In thecourse of the disease, a wide clinical spectrum is observed, from flu-like illness tolung failure. Some of the patients who survived the disease continue to have problemssuch as shortness of breath, fatigue, decrease in walking distance, decrease inparticipation in daily life activities. These problems suggest that the effects onrespiratory and cardiac functions continue even after the disease ends. This study wasdesigned to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.

Regeneron Pharmaceuticals

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease

Primary Objective:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPDSecondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

Francis Crick Institute

SARS-CoV-2 (COVID-19) Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)

Conditions: SARS-CoV Infection

The study aims to investigate SARS-CoV-2 susceptibility, transmission and diseaseseverity in healthcare workers and patients.Residual specimens from an existing collection of samples in viral inactivating bufferand derivatives and serum from the Crick COVID-19 Consortium Testing centre (Cohort A1)and additional biological material collected prospectively (Cohorts A2 and B) will beused for research into SARS-CoV-2 transmission, evolution and immune control. Thistesting centre is a partnership between UCLH and The Francis Crick Institute to provideCOVID 19 RT PCR testing for healthcare workers (HCWs) and patients in London Hospitalsand care homes. A third group (Cohort C) of the study will allow for collaborative workwith other REC approved research studies that have used the Crick COVID-19 ConsortiumTesting centre and will involve the use of study samples already collected from eachstudy to be analysed under the SARS-CoV-2 Longitudinal Study end points

SK Bioscience Co., Ltd.

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19)

Conditions: COVID-19 (Healthy Volunteers)

This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded,age-escalating study to assess the safety, reactogenicity and immunogenicity of a SKSARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with or withoutAS03 in healthy younger and older adults.

Charite University, Berlin, Germany

Analysis of the Pathophysiology and Pathology of Coronavirus Disease 2019 (COVID-19), Including Chronic Morbidity

Conditions: COVID19

NAPKON-HAP is the deep phenotyping platform of the National Pandemic Cohort Network(NAPKON) in Germany. NAPKON is a data and biospecimen collection of patients withCOVID-19 and is part of the University Medicine Network (NUM) in Germany. The primaryobjective of the study is to provide a comprehensive collection of data and biosamplesfor researchers from national consortia and for participation in international researchcollaborations for studying COVID-19 and future pandemics.Data is collected from patients with COVID-19 three times per week during theirhospitalization and at follow-up visits after hospital discharge 3, 6, 12, 24, and 36months after symptom onset. Data include epidemiological and demographic parameters,medical history and potential risk factors, documentation of routine medical procedures,and clinical course, including different patterns of organ involvement, quality of care,morbidity, and quality of life. Moreover, extensive serial high-quality bio samplingconsisting of various sample types is performed to allow deep molecular, immunological,and virological phenotyping.Patients not requiring Intensive Care Unit (ICU)/ Intermediate Care (IMC) treatment willreceive 7 and patients requiring ICU/IMC treatment will receive 16 full-phenotypingvisits including sampling for biobanking. During hospitalisation the planned bloodsampling rate in total is 35 ml at each visit. The total amounts and/or sampling datesmay differ according to the ethics committee's regulations for different study centers.At follow-up visits, the clinical assessment includes an update of the medical historyand recent medical events from which additional clinical data is collected (i.e.outpatient CT-scans, echocardiography, external laboratory data). Clinical symptoms arerecorded and a physical examination will be performed. Vital signs are recorded androutine blood testing and biosampling is continued. Quality of life is measured withpatient-reported outcome questionnaires.Follow-up visits at months 3 and 12 are "deep phenotyping" visits with a comprehensiveand detailed set of examinations. In the following visits at months 24 and 36, onlyexaminations with pathologic results from the last deep phenotyping visit at month 12will be performed.A shorter follow-up visit to record quality of life, recent medical events and with areduced number of examinations focusing on cardiorespiratory performance will take placeat month 6.In case of relevant medical events, new medical information or changes in theparticipant´s health status, an unscheduled visit can take place anytime within theentire study period.Data collection during follow up includes standardized quality of life assessmentincluding PROMIS® (Patient-Reported Outcomes Measurement Information System). Thepulmonary characterization will include body plethysmography, diffusion capacity,respiratory muscles strength measurement, spiroergometry, capillary blood gas analysisand lung imaging studies (low-dose Computed Tomography (CT), Magnetic Resonance Imaging(MRI) of the lung). Cardiological phenotyping includes echocardiography,electrocardiogram (ECG), 24h-ECG, 24h-blood pressure monitoring, stress cardiac MRI andpulse wave analysis. Neurocognitive testing includes brain MRI, electroencephalogram(EEG), somatosensory testing, refractometry (Visit 3 and 12 months), physical activitytest, neurocognitive tests, somatosensory phenotyping, taste- and smell-test.Endocrinological phenotyping will incorporate Advanced Glycation Endproducts (AGE)reader, continuous glucose monitoring for 14 days, Air Displacement Plethysmography (ADP)or bioelectrical impedance analysis (BIA).

Oslo University Hospital

Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Immune Kidney Transplant Study (COVID-19)

Conditions: Kidney Transplant Infection, SARS-CoV Infection

None of the vaccines approved, or in clinical trials, have so far been tested ontransplanted patients. If they produce an immune response to the Spike protein ofSARS-CoV-2 it is unknown how long the protective immunity will last.Not all immune responses are equal. The investigators will quantify immune cell subsetswith flow and mass cytometry analyses to describe the phenotype of responding immunecells, including specific T cells. If not already established, patient human Leukocyteantigen (HLA) genotypes will be typed.In order to compare the immune responses with healthy individuals a control group ofhospital employees will be included and sampled before and after vaccination according tothe same time schedules as the kidney transplanted patients.

University of Liverpool

AGILE (Early Phase Platform Trial for COVID-19)

Conditions: COVID19

The AGILE platform master protocol allows incorporation of a range of identified andyet-to-be-identified candidates as potential treatments for adults with COVID-19 into thetrial. Candidates will be added into the trial via candidate-specific trial (CST)protocols of this master protocol as appendices. Having one master protocol ensuresdifferent candidates are evaluated in the same consistent manor and opening up new trialsfor new candidates is more efficient. Inclusion of new candidates will be based onpre-clinical data, evidence in the clinical setting and GMP capabilities.

University of Campania Luigi Vanvitelli

Cellular-Mediated Immunity in COVID-19

Conditions: COVID19, Thromboembolism

In order to prevent reinfection, it is needed to detect the cellular-mediated immuneresponse to the Sars-CoV-2 infection. The first goal of this study will be to detect thecellular-mediated immune response in patients affected by COVID-19 (with or withoutvaccination) and healthy subjects who undergone vaccination program. The second goal ofthis study will be to identify the genetic and epigenetic biomarkers that influenceindividual immunological response and clinical evolution to the severe manifestations ofthe COVID-19.

Società Italiana Talassemie ed Emoglobinopatie

Observational Study for Patients With Hemoglobinopathies and Rare Inherited Anemia and Covid 19

Conditions: Haemoglobinopathies

The COVID-19 pandemic is causing many deaths around the world, putting a strain on healthservices. Patients with pre-existing chronic conditions are most affected by theSARS-COV2 infection. Infectious complications are a common cause of mortality and one ofthe main causes of morbidity in all these diseases. The main objective of this project isthe assessment of patients with thalassemia, drepanocytosis, other haemoglobinopathiesand rares inherited anemias suffering from SARS-COV-2 to: 1. Obtain clinical and epidemiological data that can provide information on a possible increased vulnerability of these patients to SARS-COV-2 infection; 2. Sharing therapeutic approaches considering the lack of information about the treatment.

National and Kapodistrian University of Athens

Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System

Conditions: COVID-19, Healthy Volunteers, Chronic Disease, Hematological Malignancies, Solid Tumor

Determination of both the degree and duration of the immunity provided after receivingthe BNT162b2 vaccine against SARS-Cov-2.

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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