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Home
  • About
      1. Board of Directors
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  • 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 120 of 159

Institut Cochin

Clinical and Mechanistic Study of Patients (With COVID-19 or Not) With a Recent Acrosyndrome

Conditions: Adult Patients With Lesions on Fingers or Toes

The recent and unexpected occurrence of patients with the development of skin lesions onthe hands and/ or feet has been described recently. As these cases occurredcontemporaneously with the Coronavirus Disease 2019 (COVID-19) and as it was the mostoften occurrence of de novo frostbites, the question raised of whether there is a directlink between the occurrence of these lesions and infection of the severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) the responsible for CoVID-19. Indeed,mechanisms of these lesions and the precise correlation with Sars-CoV-2 remains poorlyunderstood. Therefore, this study aim to: 1. Determine the possible link with this virus, 2. Understand the mechanisms involved in the pathogenesis of these lesions.

Medialis Ltd.

Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)

Conditions: COVID19

Coronavirus Disease 2019 (COVID-19) is a newly emerged disease, caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 pandemic is having a largeimpact on the mental and physical health of patients, yet data on the quality of life ofpost-COVID-19 patients is lacking. There are currently no post-COVID-19 specific measuresfor quality of life, particularly none which include the views of post-COVID-19 patientsthemselves. This observational study will recruit participants to contribute theirpreferences to the creation of a post-COVID-19 specific patient-reported measure onpost-COVID-19 quality of life. Participants will be split into three groups: those whowere not hospitalised; those who were hospitalised but not in intensive care units; andthose who were hospitalised and in intensive care units. The creation of this measurewill form phase 1 of the study, with 30-60 participants (10-20 in each group above)recruited to complete online surveys to find out their preferences of areas of life toinclude in such a measure. This will involve 3 online surveys, 1) to ask which areas oflife they feel are impacted and how; 2) to find consensus about the areas to be included;3) to weight the relevance of these areas in relation to each other. In phase 2recruitment will open to additional participants and all participants will be asked tocomplete the finalised post-COVID-19 quality of life measure once a month for 12 months,aiming for a minimum of 100 participants at this stage. All participants will also beasked to complete a demographic questionnaire to inform the analysis of the data.

London Health Sciences Centre

Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection

Conditions: COVID19

This is a longitudinal study of the long-term impact of COVID-19 on the lungs.Participants will be followed over a period of up to 4 years and impacts of COVID-19 onthe lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarizedxenon-129, pulmonary function tests, exercise capacity, computed tomography imaging andquestionnaires.

University of California, Irvine

The Provider Insurance Revenue Study in Healthcare Providers in the United States of America

Conditions: COVID19, Financial Disclosure

The investigators are enrolling 100 healthcare Provider volunteers (n=100) from acrossthe United States to help to evaluate and document the financial impact of COVID-19 onPhysicians and other healthcare Providers. This investigation will compare individualPhysician revenues before and after the advent of the COVID-19 pandemic. Theinvestigators expect to be able to differentiate between revenues lost due to theCOVID-19-driven business recession and revenues lost due to the manipulation ofreimbursement processes by insurance companies. The inextricable linkage between Payerand Physician revenues suggests that Payer revenues are higher at the direct expense ofPhysicians, since both streams come from the same sources of funding. The secondaryobjective is aimed at revealing the methods Payers use to retain more money.

Fondazione Don Carlo Gnocchi Onlus

The Salivary Raman COVID-19 Fingerprint

Conditions: COVID19

The outbreak of coronavirus disease 2019 (COVID-19), caused by infection of SARS-CoV-2,has rapidly spread to become a worldwide pandemic. Global research focused on theunderstanding of the biochemical infective mechanism and on the discovery of a fast,sensitive and cheap diagnostic tool, able to discriminate the current and past SARS-CoV-2infections from a minimal invasive biofluid. The fast diagnosis of COVID-19 isfundamental in order to limit and isolate the positive cases, decreasing with a promptintervention the infection spreading.The aim of the project is to characterize and validate the salivary Raman fingerprint ofCOVID-19, understanding the principal biomolecules involved in the differences betweenthe three experimental groups: 1) healthy subjects, 2) COVID-19 patients and 3) subjectswith a past infection by COVID-19. The large amount of Raman data will be used to createa salivary Raman database, associating each data with the relative clinical datacollected.Starting from the preliminary results and protocols of the Laboratory of Nanomedicine andClinical Biophotonics (LABION) - IRCCS Fondazione Don Gnocchi Milano, the salivacollected from each experimental group will be analysed using Raman spectroscopy. All thedata will be processed for the baseline, shift and normalization in order to homogenizethe signals collected and creating in this way the Raman database. The average spectrumcalculated from each group will be characterized, identifying the principal families ofbiological molecules responsible for the spectral differences.EXPECTED RESULTS: Verify the possibility to use Raman spectroscopy on saliva samples forthe identification of subjects affected by COVID-19. The principal aim of the project isto create a classification model able to: discriminate COVID-19 current and pastinfection, identify the principal biological molecules altered in saliva during theinfection, predict the clinical course of newly diagnosed COVID-19 patients, translationand application of the classification model to a portable Raman for the test of a pointof care.

Siew Chien NG

An Evaluation of a Synbiotic Formula for Patients With COVID-19 Infection

Conditions: COVID19, Microbiota

In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan,wasidentified as the culprit of this disease currently being identified as "CoronavirusDisease 2019" (COVID-19) by World Health Organization.Coronavirus was found to not only target the patient's lungs but also multiple organs.Around 2-33% of Coronavirus Disease-19 patients developed gastrointestinal symptoms.Studies have shown that Severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) wasfound in patient's feces, suggesting that the virus can spread through feces. In ourprevious study, stool samples from 15 patients with COVID-19 were analysed. Depletedsymbionts and gut dysbiosis were noted even after patients were detected negative ofSARS-CoV-2. A series of microbiota were correlated inversely with the disease severityand virus load. Gut microbiota could play a role in modulating host immune response andpotentially influence disease severity and outcomes.The investigators are uncertain about the impact of synbiotic on patients with COVID-19.However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patientswith COVID-9 who take synbiotic or not, leading to lesser progression to severe disease,less hospital stay and improved quality of life.

Imperial College London

Inflammatory Signal Inhibitors for COVID-19 (MATIS)

Conditions: Coronavirus, COVID19, Pneumonia

The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is atwo-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib(RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatmentof COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patientsprogressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for14 days and will receive follow-up assessment at 7, 14 and 28 days after the first studydose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially,n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis toassess the efficacy and safety of the treatments, approximately n=285 (95 per arm) willbe recruited during Stage 2.

Tourcoing Hospital

Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)

Conditions: Virus-HIV, COVID19

The non-essential and non-urgent follow-up consultations of patients living with HIV werepostponed or transformed into "teleconsultation" or exchanges of e-mails betweenpractitioners and patients during COVID-19 epidemic. This change in care can have animpact on follow-up and access to treatment for PVVIH.

Universidade Metodista de Piracicaba

Characteristics in Post Covid-19 Patients

Conditions: Coronavirus Infection

To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitationprotocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to beconducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging andblood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later(T3). Expected results: a) clinical, image and transcriptome changes; b)clinical-functional improvement after CPRP.

University Hospital, Strasbourg, France

COVID-19 Prevalence in HIV-infected Patients

Conditions: HIV Infections

North-east area of France was hit in February 2020 by the new coronavirus disease, moreseverely than other French regions. Factors affecting the evolution of the disease andits severity have been quickly identified, among them figuring different kinds of immunedeficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, thosepatients with uncontrolled viral load and/or low CD4 cell counts, remain at higher riskof severe COVID infection. In this context, the primary objective of our study is aimedat evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infectedpatients followed-up in an HIV-infection care center. Secondary objectives are:evaluating whether the antibodies are protective or not, the kinetic of these antibodies,and HIV associated factors with the presence of antibodies.

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Status

  • Unknown status (76)
  • Recruiting (48)
  • Active, not recruiting (27)
  • Not yet recruiting (5)
  • Enrolling by invitation (3)

Intervention Type

  • (-) Other (159)
  • Drug (17)
  • Biological (15)
  • Behavioral (6)
  • Diagnostic Test (6)
  • Procedure (4)
  • Dietary Supplement (1)
  • Radiation (1)

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© Reagan-Udall Foundation for the FDA