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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 90 of 530

University of Zurich

Microbiota in COVID-19 Patients for Future Therapeutic and Preventive Approaches

Conditions: Corona Virus Infection, ARDS, Coinfection

In light of the rapidly emerging pandemic of SARS-CoV-2 infections, the global populationand health care systems are facing unprecedented challenges through the combination oftransmission and the potential for severe disease. Acute respiratory distress syndrome(ARDS) has been found with unusual clinical features dominated by substantial alveolarfluid load. It is unknown whether this is primarily caused by endothelial dysfunctionleading to capillary leakage or direct virus induced damage. This knowledge gap issignificant because the initial balance between fluid management and circulatory supportappear to be decisive. On progression of the disease, bacterial superinfectionfacilitated by inflammation and virus related damage, has been identified as the mainfactor for patient outcome, but the role of the host versus the environment microbiomeremains unclear.The overarching aim of the present research proposal is to improve therapeutic strategiesin critically ill patients with ARDS due to SARS-CoV-2 infection by advancing thepathophysiological understanding of this novel disease. This research thus focuses oninflammation, microcirculatory dysfunction and superinfection, aiming to elucidate riskfactors (RF) for the development of severe ARDS in SARS-CoV-2 infected patients andcontribute to the rationale for therapeutic strategies. The hypotheses are that (I) theprimary damage to the lung in SARS-CoV-2 ARDS is mediated through an exaggeratedpro-inflammatory response causing primary endothelial dysfunction, and subsequentlyacting two-fold on the degradation of the lung parenchyma - through the primary cytokineresponse, and through recruitment of the inflammatory-monocyte-lymphocyte-neutrophilaxis. The pronounced inflammation and primary damage to the lung disrupts the pulmonarymicrobiome, leading secondarily to pulmonary superinfections. (II) Pulmonary bacterialsuperinfections are a significant cause of morbidity and mortality in COVID-19 patients.Pathogen colonization main Risk Factor for lower respiratory tract infections. Toestablish colonization, pathogens have to interact with the local microbiota (a.k.a.microbiome) and certain microbiome profiles will be more resistant to pathogen invasion.Finally, (III) Handheld devices used in clinical routine are a potential reservoir andcarrier of both, SARS-CoV-2, as well as bacteria causing nosocomial pneumonia.

King's College London

Testing the Accuracy of a Digital Test to Diagnose Covid-19

Conditions: COVID-19

The Covid-19 viral pandemic has caused significant global losses and disruption to allaspects of society. One of the major difficulties in controlling the spread of thiscoronavirus has been the delayed and mild (or lack of) presentation of symptoms ininfected individuals, and the insufficient Covid-19 testing capacity in the UK. Thiswarrants the development of alternative diagnostic tools that reliably assess Covid-19infection in the early stages of infection, while also being low- cost, low-burden, andeasily administered to a wide proportion of the population.This study aims to validate machine learning models as a diagnostic tool that predictsinfection with SARS-CoV-2 based on app-reported symptoms and phenotypic data, against the'gold-standard' swab PCR-test. This study will take place within the Covid Symptom Studyapp, the free symptom tracking mobile application launched in March 2020.

King's College Hospital NHS Trust

Endothelial Function, Inflammation and Organ Dysfunction in COVID-19

Conditions: COVID, Shock

COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients whichrequire intensive care unit admission. In critically ill patients infected with COVID-19,approximately 15% had severe shock requiring medications to increase blood pressure. Itappears that blood vessel tone is altered and microcirculation is not well regulated inpatients with COVID-19. The underlying pathophysiology and contributing factors areunknown. The association with subsequent organ dysfunction and outcome is also unclear.Therefore, the investigators aim to investigate serial changes of relevant biomarkers inthis population to improve the understanding of this disease, to investigate theassociation with clinically important outcomes and to find out how best to treatpatients. The data will serve to develop strategies for individualised management of thishigh-risk group.

Guy's and St Thomas' NHS Foundation Trust

Efficacy and Safety of Angiotensin II Use in Coronavirus Disease(COVID)-19 Patients With Acute Respiratory Distress Syndrome

Conditions: COVID, Acute Respiratory Distress Syndrome

This study aims to find out whether the use of angiotensin II, which is a drug to raiseblood pressure has been approved by European Medical Agency in August 2019, as an add-onmedication to increase blood pressure in patients with COVID-19, acute severe lunginjury, inflammation and severe shock, compared with standard medication. In addition,the investigators will collect the data of Anakinra, another drug which is frequentlyused in this condition to reduce inflammation.The investigators will collect clinical data and outcomes from critical care patients.The investigators will analyse for whom these drugs are most beneficial and explorewhether there are any patients who don't benefit or have side effects.

University Hospital Muenster

AKI Biomarkers in Coronavirus(COVID)-19

Conditions: COVID, Acute Respiratory Failure, Acute Kidney Injury

This research aims to investigate the role of daily measurement of urinary cell cyclearrest markers and other serum and urinary biomarkers to predict the development of acutekidney injury in critically ill patients with COVID-19 and acute respiratory disease.

Vastra Gotaland Region

COVID-19 Research in Organ Transplant Recipients

Conditions: Transplant Recipients

COVID-19 is a global major public health emergency that disproportionately affectspatients with risk factors such as advanced age, heart and lung disease, diabetes,hypertension, as well as compromised immunity. Despite the recent worldwide emergence ofthis disease and its rapid progression to a pandemic, very little is known about therisks facing solid organ recipients. The study aims to elucidate the prevalence ofsymptomatic, subclinical, and asymptomatic infection in the transplanted population byassessing their immunological response to SARS-CoV-2 infection. This will be studiedseroepidemiologically in the whole cohort and retrospectively in transplanted patientsadmitted to hospital for COVID-19.Primary objective: to elucidate the cumulative prevalence of SARS-CoV-2 infection in thetransplanted population related to symptoms and hospitalizations; to assess the magnitudeof immunological response and seroconversion kinetics for COVID-19. Secondary objectives:To examine the influence of medical parameters on COVID-19 infection and immune responsesuch as: age, comorbidities current and recent pharmacological treatment, organtransplanted, and blood type, HLA genotype.Study design:Part 1: Longitudinal cohort study for seroepidemiology and disease burden. Part 2:Retrospective case-series for seroconversion kinetics and clinical course assessment.Study population:All solid organ transplanted patients in Sweden

The Hospital for Sick Children

Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions

Conditions: Anxiety Disorder of Childhood or Adolescence

Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) havedramatically impacted the lives of children/adolescents (children) and families. Theclosure of schools, social and recreational activities, and modifications to workenvironments has led to significant changes in the way children and families are working,living and socializing. Although the impact on the mental health of children and familieshas not been well researched, it is anticipated that already stressed children andfamilies with pre-COVID-19 mental health challenges are at significant risk fordeterioration in their mental health. As such, the implementation, and evaluation(specifically: feasibility, acceptability and barriers) of virtual-care interventions toalleviate child and family anxiety and enhance family functioning are critical.Virtual-care also optimizes health equity initiatives in reducing social, economic andenvironmental barriers to services that can improve or maintain mental health (WHO, 2017;MOHLTC, 2018).The current study will evaluate an adapted virtual-care cognitive behavioural therapy(CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base intreating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, andChorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting theefficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr,and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate thefeasibility, participation barriers related to social determinants of health (SDH) andacceptability of this virtual-care intervention in addressing mental health challengesassociated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Earlyevaluation of this virtual-care intervention will enable future scale-up of thisintervention during the post-pandemic recovery time-period and during subsequent COVID-19waves, if necessary.

Versailles Hospital

RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19

Conditions: SARS-CoV Infection, Pinkeye

the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctivaof covid-19 patients and the presence or absence of conjunctivitis in these patients

University Hospital, Lille

Risk of Air Contamination During Visceral Surgery in COVID19 Patients

Conditions: SARS-COV2, Surgery, COVID

Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract.Protection of health care workers during surgery has been increased and some guidelinesadvocate for abandoning laparoscopy in COVID19 patients for fear of contamination,evenghtough this does not benefit the patient. However, Sars-Cov2 contamination riskduring visceral surgery remains unknown. Inadequate protection is unnecessary costful andcan be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travelthrough droplet and air during visceral surgery. 2) Laparoscopy, because of thepneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrantmore droplet contamination, which would justified increased protection.

University of Minnesota

The Professional Peer Resilience Initiative

Conditions: Stress, Stress Disorder, Stress, Psychological, Trauma, Psychological, Anxiety, Anxiety State, Post Traumatic Stress Disorder, Secondary Traumatic Stress, Professional Quality of Life, Stress Related Disorder, Stress Reaction, Stress Risk, Mental Resilience, Emotional Resilience

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimedat understanding how symptoms of traumatic stress and resilience evolve over time in theUniversity of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019(COVID-19) pandemic. The study is being conducted concurrently with a UMN peer supportprogram called the MinnRAP program and will remotely administer quality of life andmental health surveys to healthcare workers before they start the MinnRAP program andthroughout their participation in the program.

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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)

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© Reagan-Udall Foundation for the FDA