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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 190 of 254

Asociacion para el Estudio de las Enfermedades Infecciosas

Differences in Immune Response Among HIV-1-infected Individuals With Previous or Current COVID-19 (CoVIHDis).

Conditions: COVID19, Immune Suppression, HIV-1-infection

People living with HIV could have different susceptibility and outcome to the SARS CoV-2infection. The risk of SARS CoV-2 infection in this population could be no related to HIVinfection, immunodepression or antiretroviral therapy, but to the differentsusceptibility as measured by ACE2 or CD26 receptors. Also, patients with HIV-1 infectioncould have different cytokine profile and cellular immune response after SARS-CoV-2infection, leading to a differential outcome,

Hôpital Européen Marseille

Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital

Conditions: COVID19

The purpose of the study is to Assess of Long-term impact post COVID for patients andhealth care professionals.The patients and medical staff will be followed for 2 years inorder to provide clinical and paraclinical data not yet published in the literature.

Fifth Affiliated Hospital, Sun Yat-Sen University

Study for Quantitative Analysis of the Recovered COVID-19 Patients by 18F-FDG-PET/CT

Conditions: PET/CT, COVID-19, Respiratory Function, Inflammatory Lesions

In this study, clinically cured patients with severe COVID-19 were used to evaluate thetherapeutic effect of COVID-19 and the recovery and health status of patients over timewith highly sensitive PET/CT imaging technology. At the same time, PET/CT whole bodyscan, dynamic imaging and mathematical dynamic model were combined to evaluate thefunctions of the heart, lung, liver, kidney, brain and other important organs and theoutcome of inflammatory lesions in clinically cured COVID-19 patients.

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.

Jordi Alonso

MIND/COVID-19: Mental Health Impact and NeeDs Associated With COVID-19: a Comprehensive National Evaluation in Spain

Conditions: COVID19, Mental Health Disorder, Mental Health Conditions

The aim of the proposed project is to provide a comprehensive assessment of the mentalhealth impact of the ongoing COVID-19 outbreak in Spain. A prospective cohort study ofthree groups will be conducted: (1) COVID-19 cases or close contacts recently isolated orquarantined; (2) healthcare workers; (3) adult general population.Recruitment through epidemiologic surveillance services, hospitals, primary care centersin 6 Spanish Autonomous Communities (groups 1 & 2) and a random sample of individualsusing telephone numbers as the sampling frames(group 3). Web-based surveys or telephoneinterviews at baseline and 6-month follow-up assess: current living and employmentstatus; COVID-19 infection status; mental health (post-traumatic stress, panic,depression, anxiety, alcohol and substance use, suicidality; services use); psychologicalfunctioning; general health status and quality of life. Specific modules focus onisolation or quarantine (group 1) and care for COVID-19 patients (group 2). Shortbi-weekly brief follow-up surveys among groups 1 & 2 will provide additional assessmentof main outcomes in the two months following baseline assessment.

The Hospital for Sick Children

Convalescent Plasma for COVID-19 Research Donor Study

Conditions: COVID19

Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, naturalhistory study of plasma donors recovered from COVID-19. CONCOR-Donor study will addressimmune response, duration of protective immunity, and clinical factors and host geneticscontributing to the variability of immune response. We will also study long-term outcomesfrom COVID-19 infection. Results from the study will help define therapeutic strategiesfor COVID-19.

Istituto Clinico Humanitas

Epidemiologic, Clinical and Molecular Characteristics of Patients With Acute Respiratory Failure Affected by 2019-NCOV.

Conditions: COVID19

The main purpose of this study is to identify possible predictor factor of mortality inpatients affected by COVID-19 with respiratory failure needing oxygen therapy orventilatory support. In addiction the study aims to identify factors related to:predisposition to SARS-CoV2 viral infection, different symptoms, response to therapy,predisposition to complications related to the disease. To this end, the haemodynamicparameters and all imaging reports will be evaluated and clinical and laboratory tests aswell as cellular and molecular analyzes will be performed in the analyzed patients. Inaddition, investigations will be carried out on the profile of the alveolar or nasalmicrobiota and, if possible, of the metabolic products, and estimates on antibody titers.

McMaster University

COVID-19 Related Lung Ventilation and Perfusion Injury

Conditions: COVID-19, Asthma, Healthy

Little is currently known about the immediate and long-term effect of COVID-19 on lungventilation (delivery of air to the lungs) and lung perfusion (delivery of blood to thelungs). Some people who survive COVID-19 may have lung ventilation and/or perfusioninjury that persists following COVID-19 recovery. This lung injury may be related toinflammation in the lung, breathlessness, exercise limitation and reduced quality oflife. Therefore, towards the goal of understanding the effects of COVID-19 on lunghealth, the purpose of this study is to characterize and understand the clinicalrelevance of COVID-19 related lung ventilation and perfusion injury and associatedinflammatory status, ≤4 weeks and 6-months following COVID-19 recovery in an asthmaticand healthy population. To do this, an asthmatic and healthy population who have, andhave not, been previously diagnosed with COVID-19 will be studied.

Centre Hospitalier Universitaire, Amiens

Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients

Conditions: COVID19, Neurological Manifestations, Brain Damage

Viral pandemics, such as HIV and SARS-Cov-V1, have shown that they can lead to acute and/ or delayed neurological complications. At the actual context of the pandemicCoronavirus disease 2019 (COVID-19), neurological manifestations seem to be confirmedsince in 85% of COVID-19 patients, present neurological symptoms, including anosmia,ageusia, periorbital pain, dizziness, fatigue, even moderate headache, moderate memoryand/or behavioral disorders.However, these neurological manifestations are not well studied and their radiologicalfeatures are not well described. It is therefore important to assess these potentialneurological complications in COVID-19 patients. To the investigator knowledge, there isno previous study in the literature describing spectral brain changes in COVID +patients. Thus, the goal of this work is to describe the radiological semiology using MRIand particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the evaluation ofacute and / or delayed brain damage in COVID + patients presenting a neurologicalmanifestations that are initially related to the cranial nerves damage.

La Tour Hospital

Impact of COVID-19 Outbreak on Non-COVID-19 Patients

Conditions: COVID-19

The Geneva Canton organized the health crisis of the COVID-19 epidemic around the care ofCOVID patients at the University Hospital (HUG), by moving the care of non-COVID patientsto private hospitals of the canton. The COVID epidemic appears to have been associatedwith a decrease in consultations and care for non-COVID patients. An excess of morbidityand mortality (non-COVID) would be possible during or after the epidemic in connectionwith this "under-medicalization" of non-COVID patients.The aim of this study is to measure and analyze the impact on the morbidity and mortalityof inpatients during and after the COVID-19 epidemic in the adult inpatient wards of HUGand township hospitals / clinics.

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Status

  • (-) Unknown status (254)

Intervention Type

  • Other (76)
  • Drug (64)
  • Biological (35)
  • Diagnostic Test (29)
  • Behavioral (10)
  • Device (8)
  • Procedure (6)
  • Combination Product (5)
  • Dietary Supplement (4)
  • Radiation (3)

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