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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 24

University Hospital, Clermont-Ferrand

Influence of the COVId-19 Pandemic on STRESS of Occupational Health Workers

Conditions: Occupational Health

Coronavirus has caused containment of more than half of the world's population and amajor and rapid reorganization of clinical and support services. The spread ofcoronavirus (COVID-19) has posed significant challenges for occupational health services.However, there is currently no data on the influence of this epidemic on the practice andfeelings of dental surgeons and associates

University Hospital of Ferrara

Recovery Profiles in Patients With SARS-CoV-2 Outcomes Undergoing Rehabilitation

Conditions: Covid19_rehabilitation

COVID19 patients survivors, after discharge from hospital show reduced lung function andreduced ability to exercise. Furthermore, mental health problems including stress,anxiety and depression and a low quality of life were observed. The prospectiveobservational study involves COVID19 patients who have needed rehabilitation at theUniversity Hospital of Ferrara. Patients receive comprehensive rehabilitation based ontheir specific needs in both acute and subacute rehabilitation. At the end of hospitalrehabilitation, patients are offered a program to be carried out at home for bothphysical and psychological problems. A range of demographic and clinical data will becollected. Patients will also undergo a battery of functional, cognitive andpsychological tests at 12, 26 and 52 weeks from the infection onset. Moreover, a specificassessement (both clinical and instrumental) on the pain symptom experienced, wherepresent, will be done.

University Health Network, Toronto

COVID-19 Burnout Study

Conditions: Stress

The aims of this study are to assess whether the use of a MBI therapy delivered remotelyis associated with a reduction of perceived stress among HCPs in the Radiation MedicineProgram (RMP) and with a decrease risk of burnout during and post COVID-19.

GlaxoSmithKline

MGUS, SMM, and MM Patient Experience With Coronavirus 19 (COVID-19) Survey

Conditions: Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Coronavirus

The purpose of this study is to examine how patients with multiple myeloma (MM) have beenimpacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.The study will use a questionnaire to further understand how patients are being affectedand gather information in order to track the long-term effects of the coronavirus.The scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes inmyeloma treatment and care, clinical trial familiarity, health and fitness, and qualityof life.This questionnaire is a follow-on to the "MM and COVID-19" questionnaire.

Assistance Publique - Hôpitaux de Paris

French Cohort of COVID-19 Patients With Post-intensive Care Syndrome

Conditions: COVID19

The purpose of this study is to describe post-intensive care syndrome (PICS) of patientssurviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recoveryprocess from hospital to home return

Columbia University

Mother-infant Bonding During COVID-19

Conditions: Child Development, Mother-Infant Interaction, Relation, Parent-Child

This study will assess whether the promotion of emotional exchange between mother andinfant during the first four months of life improves primarily mother-child earlyrelational health (ERH) and secondarily child neurodevelopmental and maternal mentalhealth outcomes. In prior research on preterm infants, a similar interventiondemonstrated increased quality of maternal caregiving behaviors and significantimprovements in premature infants' neurodevelopment across multiple domains, includingsocial-relatedness and attention problems. The goal of the emotional exchangeintervention is to help mothers provide appropriate stimulation crucial for social,emotional, and neurobehavioral development, by helping the mother and child becomeattuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternalsensitivity, and mother-child emotional connection will be compared between two groups:one receiving newborn parenting education and the other undergoing facilitated emotionalexchange. Assessments will involve videos of mother-infant interactions during eachintervention session and follow-up surveys conducted as part of a linked InstitutionalReview Board-approved study. Data collected in this study will contribute tounderstanding the underlying mechanisms of mother-infant interactions and their role inshaping optimal neurodevelopmental trajectories for infants and maternal mental health.

Ohio State University

OUR Stress/ Emotion Management for Black/African American Women With Hypertension

Conditions: Stress, Psychological

Covid-19 is an additional stressor Black women have to deal with that may interfere withhypertension self-care management. Social connectedness is a source of resilience forBlack women to promote mental and physical health. Unfortunately, in the face of theCovid-19 pandemic, social distancing is a challenge further isolating Black women fromtheir networks. How is social connectedness to manage stress and emotional well-being ina social-distancing society for Black women with hypertension? The research team proposeda synchronous web-based version of Enhanced Co-Created Health Education InterventioN(eCo-CHIN) that build the success and best practices derived from the originalintervention. A Covid-19 session will be included as a way of helping Black women tomaintain resilience and self-care during stressful times. The eCo-CHIN intervention isinnovative and timely because the research team are using a synchronous platformpreparing Black women on how to deal with Covid-19 while taking care of self. The primaryinvestigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator andformer KL2 (career development) awardee. The interdisciplinary research team has theexpertise and resources to deliver this Enhanced Co-CHIN intervention.

Direction Centrale du Service de Santé des Armées

Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions

Conditions: COVID19, SARS-CoV Infection, Burnout, Caregiver, Burnout, Professional

Stress is underpinned by a biological reaction of the organism allowing the production ofenergy to respond to a change in the environment (or stressor). Stress reaction isexpressed in behavioural, cognitive, emotional and physiological terms. This biologicalresponse is non-specific because it is the same regardless of the stressor. Its evolutionover time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome(GAS) which comprises three successive phases. (i) The first phase, known as the alarmphase, corresponds to the activation of all biological mechanisms according to a trendregulation, allowing a rapid response to the stressor. (ii) The second phase ofresistance which adjusts the stress response to the intensity of the perceived aggressionaccording to a constant regulation. (iii) When the aggression disappears, a recoveryphase dominated by the return of the parasympathetic brake allows a return to homeostasis(eustress).The "primum movens" of all pathologies is therefore the inability of the individual toadapt his stress response in duration and/or intensity to the course of the phases of theGAS (distress). The perception of not being in control of the situation contributes tothe perceived stress and constitutes a well-established risk of distress. It is a riskfactor for the emergence of burnout. It induces a biological cost called allostatic cost.Allostasis is a concept that characterizes the process of restoring homeostasis in thepresence of a physiological challenge. The term "allostasis" means "achieving stabilitythrough change", and refers in part to the process of increasing sympathetic activity andcorticotropic axis to promote adaptation and restore homeostasis. Allostasis works wellwhen allostasis systems are initiated when needed and turned off when they are no longerrequired. Restoring homeostasis involves effective functioning of the parasympatheticsystem. However, when the allostasis systems remain active, such as during chronicstress, they can cause tissue burnout and accelerate pathophysiological processes.The perception of uncontrollability depends on the stress situation, the psychologicaland physiological characteristics of the subject and his or her technical skills inresponding to the stressors of the situation. In particular, subjects with a high levelof mindfulness are more accepting of uncontrollability and less likely to activate thestress response.The COVID-19 pandemic situation is a situation characterized by many uncertainties aboutthe individual, family and work environment and the risk of COVID infection. Healthcareworkers, like the military, are high-risk occupations that are particularly exposed tothese uncertainties in the course of their work and continue to work in an uncertainsituation. These professionals are described as a population at risk ofoccupational/operational burnout that the level of burnout operationalises. Thisancillary study in a population of civilian and military non-healthcare workers willcomplement the study conducted among military health care workers. It will make itpossible to isolate the specificity of each profession (civilian or military, healthcarepersonnel or not) with regard to the risk of burnout in the COVID context.The objective of this project is to evaluate the impact of the perception of non-controlin the operational burnout of experts in their field of practice and to study thepsychological and physiological mechanisms mediating the relationship between thesubject's characteristics, perceived non-control and burnout.

University of Ottawa

Enhancing COVID Rehabilitation With Technology

Conditions: COVID19

In March 2020, the World Health Organization (WHO) declared the novel coronavirus(COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19since testing began. For many of these patients, symptoms resolve within 4 weeks ofonset. However, it is becoming apparent that a significant number of individuals areexperiencing symptoms that persist long after the acute infection, known as Long COVID.These individuals have a wide constellation of presenting symptoms, often varying frominitial presentation. For this study, we will be enrolling individuals receiving care atThe Ottawa Hospital for Long COVID. This study aims to determine the following fourthings: 1) will adding electronic case management improve quality of life three monthsafter coming to hospital with Long COVID; 2) is the electronic case management platformcost effective; 3) is there any factors that predict outcomes at 3 months; 4) todetermine how a personalized rehabilitation program supported by a digital platform couldbe implemented for individuals with Long COVID. We will enroll individuals from TheOttawa Hospital who will then be randomly assigned to receive either usual care or usualcare plus electronic case management, through a platform called NexJ Connected Wellness.Participants will also complete questionnaires every 4 weeks for 3 months. We will belooking at quality of life, mental and physical health, cognitive symptoms, fatigue andpain.

Ohio University

Acceptability/Feasibility of COVID-19 Intervention

Conditions: Social Isolation, Emotional Disorder

The coronavirus (COVID-19) pandemic is a significant psychological stressor thatthreatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19and its economic impact, as well as loneliness due to the required social isolation, aredriving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll,45% of respondents reported that the coronavirus has had a negative impact on theirmental health. This is reflected in Southeastern Ohio. In data that the investigatorscollected from 317 Ohio University faculty, staff, and students from late May to earlyJune, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severelevels of depression and 57% reported the COVID-19 outbreak was impacting their sense ofsocial connection much or very much. Despite the significant community need foraccessible and affordable care, there are currently no evidence-based interventions forindividuals coping poorly with coronavirus-related distress. The investigators havedeveloped a virtual group-based intervention targeting cognitive biases that amplify theexperience of stress and anxiety (i.e., amplifying cognitions; Coping withCoronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing thisintervention in a scientifically rigorous manner is to refine the manual and proceduresand conduct a pilot test of the intervention.

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Status

  • Unknown status (10)
  • Recruiting (8)
  • Active, not recruiting (5)
  • Enrolling by invitation (1)

Intervention Type

  • (-) Behavioral (24)
  • Other (6)
  • Biological (2)
  • Device (1)

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