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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 20 of 116

Hôpital Forcilles

One-Year Quality of Life and Functional Prognosis of COVID-19 Patients in Post-ICU Setting

Conditions: COVID-19, ICU Acquired Weakness, Weaning Failure

The COVID-19 disease has been subject to numerous publications since its emergence.Almost 20% of people suffering from COVID-19 develop severe to critical symptoms andrequire hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is themain reason for admission in ICU of these patients. Therapeutic strategies implementedfor the management of critically-ill patients may often lead to short-term muscular andfunctional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead tolong-term disabilities expressing trough dependence and quality of life impairment ofsurvivors.The purpose of this study is to assess the quality of life, dependence and survival atone year in patients who survived from COVID-19 in ICU and are admitted in post-ICUsetting for difficult weaning purpose.Ancillary studies aim to assess the course of muscle function (atrophy, structuralmodifications), lung function (loss of aeration) and safety of early mobilization.

Canadian Institutes of Health Research (CIHR)

Peer Champion Support for Hospital Staff During and After the COVID-19 Pandemic

Conditions: Burnout

Experience from the 2003 Severe Acute Respiratory Syndrome (SARS) outbreak taught thathealthcare workers (HCWs) often experience chronic stress effects for months or yearsafter such an event, and that supporting HCWs requires attention to the marathon ofoccupational stress, not just the sprint of dramatic stressors that occur whileinfections are dominating the news. This study will test if the well-being of hospitalworkers facing a novel coronavirus outbreak is improved by adding either of twointerventions: (1) Peer Resilience Champions (PRC): an interdisciplinary team ofprofessionals who actively monitor for early signs of heightened stress within clinicalteams, liaise between staff and senior management to improve organizationalresponsiveness, and provide direct support and teaching (under the supervision of expertsin resilience, infection control, and professional education). Investigators will testthe effectiveness of this PRC Intervention by rolling it out to different parts of thehospital in stages and comparing levels of burnout before and after the interventionreaches particular teams and units (a stepped wedge design). By the end of the study, PRCSupport will have been provided to all clinical and research staff and many learners (>6,000 people). Note that the provision of PRC support will be directed to the entireorganization. The research portion of the study is the evaluation of PRC support througha repeated survey completed by consenting staff. Investigators will test theeffectiveness of the PRC by measuring trends in burnout and other effects of stress overthe course of the study in a subgroup of hospital workers (as many as consent, target~1000 people) through an online questionnaire (called "How Are You?"). (2) The secondintervention is an enriched version of the "How Are You?" Survey, which providespersonalized feedback about coping, interpersonal interactions and moral distress.Participants will be randomized (1:1) to receive the shorter Express Survey (identifyingdata and outcome measures only), or the Enriched survey (all of the Express measures plusadditional measures with feedback based on responses). It is hypothesized that both thePRC intervention and the Enriched Survey intervention will help prevent or reduceinstances of burnout in HCWs.

Villanova University

COVID-19 CHAMPS Study of Healthcare, First Responder and Service Workers

Conditions: Occupational Exposure to SARS-CoV-2, COVID-19

The COVID-19 CHAMPS Study will obtain data on the physical and mental health andwell-being of workers potentially exposed to the SARS-CoV-2 virus in the course of theirduties. Included are a broad range of occupations including those working in thecommunity (police officers, firefighters, emergency personnel, screening staff) as wellas in permanent or temporary sites that care for patients (service staff, nurses,physicians and other health professionals). CHAMPS will obtain data on various exposurefactors and health and create a registry of participants for extended follow up andsub-studies.

Centre Hospitalier Universitaire, Amiens

COVID-19 Infection in Patients With Hepatocellular Carcinoma

Conditions: HepatoCellular Carcinoma, COVID-19

Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all5 continents, and responsible for a pandemic. France is the third most affected countryin Europe after Italy and Spain. Groups of patients at a higher risk of developing asevere form of COVID-19 have been defined: this include patients with immunosuppressivedisease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liverinjury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damageassociated with COVID-19 infection for compensated or decompensated cirrhotic patients.The objectives of this project are to estimate the incidence of COVID-19 inhepatocellular carcinoma population, both hospital and ambulatory, and to study theimpact on the frequency of severe forms, the prognosis, but also liver function, and themanagement of hepatocellular carcinoma, in this context of pandemic

Johan Normark

Host-pathogen Interactions, Immune Response, and Clinical Prognosis at COVID-19 - the CoVUm Trial

Conditions: COVID-19

The project aims to clarify how immunity to SARS-CoV2 develops in humans and toinvestigate the possibility of finding patients with a particularly effective,neutralizing antibody response for future treatment. The project also aims to detail thevirus's damage mechanisms in tissue.

Memorial Sloan Kettering Cancer Center

A Study of N-acetylcysteine in Patients With COVID-19 Infection

Conditions: COVID-19

The study researchers think that a medication called N-acetylcysteine can help fight theCOVID-19 virus by boosting a type of cell in your immune system that attacks infections.By helping your immune system fight the virus, the researchers think that the infectionwill get better, which could allow the patient to be moved out of the critical care unitor go off a ventilator, or prevent them from moving into a critical care unit or going ona ventilator.The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat theliver side effects resulting from an overdose of the anti-inflammatory medicationTylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in thelungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD).This study is the first to test N-acetylcysteine in people with severe COVID-19infections.

University of Oxford

A Study of a Candidate COVID-19 Vaccine (COV001)

Conditions: Coronavirus

A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safetyand immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administeredintramuscularly (IM) into the deltoid region of the arm

Lisa Barrett

Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Conditions: COVID-19

Investigational medications adjunct to clinical standard of care treatment will beassessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. Allhospitalized persons with moderate to severe COVID-19 disease that meet eligibilitycriteria will be offered participation.

Jewish General Hospital

First Level Socio-geriatric Evaluation: ESOGER Databank

Conditions: COVID, Social Isolation, Anxiety, Frailty

Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is oneof the most effective ways to reduce the spread of COVID-19, but this key preventionintervention may have adverse consequences on older adults living at home. Screeningolder adults living at home and at risk for adverse consequences of physical and socialdistancing is, therefore, a priority in order to prevent their occurrence. ESOGER("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen therisk-levels for adverse consequences related to COVID-19 physical distancing and 2) tocontinue appropriate preventive interventions in older adults living at home includingfrail older patients and older community dwellers. Experience cumulated during the pasttwo weeks revealed that ESOGER could be improved, in order to be more effective andefficient for the prevention of adverse consequences related to COVID-19 physicaldistancing. This improvement is based on two key components: 1) Comments of MontrealESOGER users and 2) Analysis of data. Because at this time no information is saved andstored, there is a need to save and store ESOGER information and create the ESOGERdatabank.

University of Maryland, Baltimore

Trial of Imatinib for Hospitalized Adults With COVID-19

Conditions: COVID-19

This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety andEfficacy of Imatinib for Hospitalized Adults with COVID-19

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Status

  • (-) Active, not recruiting (116)

Intervention Type

  • Drug (37)
  • Other (27)
  • Biological (17)
  • Diagnostic Test (14)
  • Behavioral (5)
  • Procedure (5)
  • Device (2)
  • Dietary Supplement (2)
  • Radiation (2)

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© Reagan-Udall Foundation for the FDA