Skip to main content
Home
  • About
    • Board of Directors
    • Our Staff
    • Annual Reports
    • Policies
    • Fellowship
    • Careers
  • Projects
    • Column 1
      • Advancing Regulatory Science
        • Oncology Multi-Regional Clinical Trials
        • Rare Disease Innovation Roundtable
      • Animal Health & Veterinary Medicine
        • Antimicrobial Use in Food Animals
        • Cross-Sectoral Health Threats
        • Industry SWOT Analysis
      • Expanded Access
        • E-request App
        • Navigator
        • Resources for COVID-19
      • FDA Patient Listening Sessions
    • Column 2
      • Food & Nutrition
        • About
        • Food Traceability
        • Healthy Rule Roundtables
        • Nutrition Facts Label
        • Produce Safety Stakeholder Dialogue
        • Retail Dietitian Toolkit
      • Improving Access to FDA Information
        • Understanding FDA & FDA-Regulated Products
        • Improving Access to Publicly Available FDA Information
      • Research
        • About
        • IMEDS
          • IMEDS Inquiry
        • Post Market Research
        • RAISE
        • Real World Data
        • Regulatory Science Accelerator
    • Substance Use Disorders
  • News and Events
    • Innovations in Regulatory Science & Policy Awards
    • Events
    • News
    • Publications
    • 2026 Annual Public Meeting
  • Expanded Access eRequest
  • facebook
  • twitter
  • linkedin
  • youtube
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 50 of 530

Emory University

Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System

Conditions: Acute Respiratory Distress Syndrome, COVID-19

The purpose of this pilot study is to measure the impact of non-invasive pneumaticmanipulation of transthoracic pressure on oxygenation in patients with Acute RespiratoryDistress Syndrome (ARDS) due to Coronavirus Disease 2019 (COVID 19) who are on mechanicalventilator support. This will be achieved by a pneumatic Vest placed around the chestwall of consenting patients who meet inclusion criteria. The Vest is essentially anon-invasive segmental device placed upon the anterior and posterior right and leftaspects of the chest wall. The researchers have the ability to inflate and deflate thechambers of the Vest to achieve preset pressures as determined by the protocol andobserve the patient's physiological response. Participants will have up to four hours ofintervention with the study intervention, followed by 1 hour of post-interventionobservation.

Columbia University

ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers

Conditions: COVID-19, Coronavirus Infection, Coronavirus

The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has poseda challenge globally. Health care providers are highly exposed and are an important groupto test. On top of these concerns, health care workers are also stressed by the needs onresponders in the COVID-19 crisis. The investigators will look at different ways tomeasure how common COVID-19 is among health care workers, how common is the presence ofantibodies by serological tests (also known as serostatus). The investigators willdescribe health worker mental and emotional well-being and their coping strategies intheir institutional settings. Lastly, the investigators will describe how knowingserostatus can affect individuals' mental and emotional well-being and how to cope in themidst of the COVID-19 response. This will help to how to better test and help healthcareworkers in the COVID-19 pandemic and prepare for possible future outbreaks.

Celularity Incorporated

Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19

Conditions: Coronavirus, Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2, Pneumonia, Pneumonia, Viral, Lung Diseases, Respiratory Tract Disease, Respiratory Tract Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Virus Disease, Immunologic Disease, ARDS, Immunologic Factors, Physiological Effects of Drugs, Antiviral Agents, Anti-infective Agents, Analgesics, Antimetabolites, Antineoplastic

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, animmunotherapy containing Natural Killer (NK) cells derived from human placental CD34+cells and culture-expanded, in patients with moderate COVID-19 disease.

University of Milan

The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients

Conditions: COVID19, Diabetes Mellitus, Type 2, CKD

The COVID-19 pathology is frequently associated with diabetes mellitus and metabolicsyndrome. In the epidemic outbreak that exploded at the beginning of 2020 in the LombardyRegion, about two thirds of the patients who died from COVID-19 were affected by diabetesmellitus. COVID-19 occurs in 70% of cases with an inflammatory pathology of the airwaysthat can be fed by a cytokine storm and result in severe respiratory failure (10% cases)and death (5%). The pathophysiological molecular mechanisms are currently not clearlydefined. It is hypothesized that the transmembrane glycoprotein type II CD26, known forthe enzyme activity Dipeptilpeptidase 4 of the extracellular domain, may play a main rolein this condition. It is in fact considerably expressed at the level of parenchyma andpulmonary interstitium and carries out both systemic and paracrine enzymatic activity,modulating the function of various proinflammatory cytokines, growth factors andvasoactive peptides in the deep respiratory tract. Of particular interest is the factthat Dipeptilpeptidase 4 has been identified as a cellular receptor for S glycoprotein ofMERS-COV. In the case of the SARS-COV 2 virus, the main receptor is theAngiotensin-Converting Enzyme 2 protein, but a possible interaction withDipeptilpeptidase 4 also cannot be excluded. The selective blockade of Dipeptilpeptidase4 could therefore favorably modulate the pulmonary inflammatory response in the subjectaffected by COVID-19. This protein is also known for the enzymatic degradation functionof the native glucagon-like peptide 1, one of the main regulators of insulin secretion.This is why it is a molecular target in the treatment of diabetes (drugs that selectivelyinhibit Dipeptilpeptidase 4 are marketed with an indication for the treatment of type 2diabetes). It is believed that the use of a Dipeptilpeptidase 4 inhibitor in people withdiabetes and hospitalized for Covid-19 may be safe and of particular interest for anevaluation of the effects on laboratory and instrumental indicators of inflammatory lungdisease. Among the drugs that selectively block Dipeptilpeptidase 4, the one with thegreatest affinity is Sitagliptin.

The University of Hong Kong

The Psychological Impact of the COVID-19 on Students.

Conditions: Mental Health Wellness 1

The COVID-19 outbreak has been rapidly transmitted in late January 2020 and arousedenormous attention globally. The public at large may also experience boredom,disappointment, and irritability under the isolation measures. Depression and anxiety arecommon mental health problems experienced by university students. This survey aims toinvestigate the psychological impact of COVID 19 on students.

Queen Mary Hospital, Hong Kong

The Psychological Impact of COVID-19 Outbreak on COVID-19 Survivors and Their Families

Conditions: Mental Health Wellness 1

Patients with COVID-19 diagnoses are treated under isolation in hospitals and withhigh-stress level. Currently, there is little information on the mental healthimplications of exposure amongst COVID-19 survivors and their family members. Researchexploring the psychological impact amongst survivors of exposure to COVID-19 isdesperately needed to understand the effects, mental health toll, and support required insurvivors of COVID-19. This study aims to assess the psychological impact of the COVID-19outbreak on COVID-19 survivors and their family members.

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.

St. Jude Children's Research Hospital

Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children

Conditions: Corona Virus Infection, Pediatric Cancer, Adult Children, Cancer

Patient are being asked to provide respiratory and blood samples for a clinical researchstudy because the patients have a virus called the novel coronavirus, or SARS-CoV-2, thatcauses the disease known as Covid-19.Investigators do not know a lot about this virus, including all the ways it travels fromperson to person. Investigators also do not know if a person will get sick or not fromthe virus after being in close contact with someone who has the virus. Because of this,investigators are performing research on the virus found in respiratory secretions to getmore information on how investigators can best detect and treat this new virus in thefuture.Primary Objective - To determine the clinical characteristics and outcomes of Covid-19 in children. - To characterize the clinical risk factors of Covid-19 in children..Secondary Objectives - To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children. - To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

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.

Pagination

  • First page « First
  • Previous page ‹‹
  • Page 1
  • Page 2
  • Page 3
  • Page 4
  • Current page 5
  • Page 6
  • Page 7
  • Page 8
  • Page 9
  • …
  • Next page ››
  • Last page Last »

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)

Subscribe for updates from the Reagan-Udall Foundation for the FDA

Subscribe
(202) 849 - 2075
1333 New Hampshire Ave, NW
Suite 420
Washington, DC 20036
admin@reaganudall.org
  • facebook
  • twitter
  • linkedin
  • youtube

© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA