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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 40 of 51

Sanofi

RSV Burden in Outpatient Settings

Conditions: RSV Infection, Children, Only, Outpatient, Bronchiolitis, Otitis Media, Pneumonia

Strengthening outpatient low respiratory tract infection surveillance to document theburden of Respiratory Syncytial Virus (RSV)

Palas GmbH

Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Conditions: SARS-CoV-2 Infection, COVID19

The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe AcuteRespiratory Syndrome Corona Virus 2) positive and negative children and adults with theResp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratoryaerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established.Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive andnegative participants (children and adults) will be conducted. In addition to themeasurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratoryinflammatory markers will be analyzed.

Mercy Research

Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19

Conditions: COVID19, Pregnancy Related, Maternal Complication of Pregnancy, Coronavirus, Neonatal Infection, Prenatal Stress, Preterm Birth

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated withan increased risk preterm birth, cesarean section, and maternal critical care. This studywill examine the factors that impede testing for SARS-CoV-2 (the causative virus amongpregnant women), help determine optimal testing strategies by evaluating the necessity oftesting for asymptomatic disease in pregnancy, inform prenatal care plans by assessingthe full impact of infection, and contribute to a provider's ability to counsel women andcreate prenatal care plans if they are pregnant or considering pregnancy.

University Hospital, Rouen

Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

Conditions: Corona Virus Infection

At present, the offer of tests for the serological diagnosis of CoVID-19 (detection ofIgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of avery large number of rapid diagnostic unit tests, a few dedicated high throughputautomated systems or reagents on existing open systems. The offer will continue to expandin the coming months.In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HASreport of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific councilconcerning the potential use of these serological tests at the end of the COVID-19epidemic, the Virology laboratory wishes to validate the sensitivity and specificity ofthe tests it intends to use.

London Health Sciences Centre

Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection

Conditions: COVID19

This is a longitudinal study of the long-term impact of COVID-19 on the lungs.Participants will be followed over a period of up to 4 years and impacts of COVID-19 onthe lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarizedxenon-129, pulmonary function tests, exercise capacity, computed tomography imaging andquestionnaires.

Assiut University

Patterns of Arrhythmias and Conduction Block in COVID-19 Patients and Its Relation to Myocardial Injury Detected by Cardiac Magnetic Resonance

Conditions: COVID19

Detection of the incidence and types of arrhythmia and conduction block in COVID - 19patients Detection and description of CMR patterns of myocardial injury in COVID-19patients with arrhythmias.

University of Erlangen-Nürnberg Medical School

SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)

Conditions: SARS-COV2

Since the beginning of the year, the entire world has been concerned with the novelSARS-CoV2 virus. After the first case descriptions in Wuhan, there has been a rapidincrease in the number of cases in Germany as well. In case of an illness with the virus,the affected patients can suffer from a slight infection of the upper respiratory tractup to severe lung failure and death. Interestingly, up to now, children are usually lessseverely affected than adults. However, the actual infection rates are probably similarto those of adults, even if the actual prevalence in children is difficult to quantify sofar. The extent of the disease in children has also been less researched to date than inadults, and the same applies to pregnant women and their newborns. In addition, intensiveresearch into possible therapeutic strategies and new vaccines is necessary. Here,however, the number of clinical studies in children is also far behind. In order to beable to understand the infection process and to protect the population with theirchildren, comprehensive testing is necessary. However, this poses great challenges forlocal health authorities. Scientific investigations are also costly, but are alreadybeing carried out by many institutes. So far, for example in the SeBlueCo study, a verylow prevalence of antibodies (1.3% of people) has been show. In children, however, boththe routes of infection and the way the immune system deals with the virus are probablydifferent than in adults. In this study the investigators now want to examine residualblood samples from pediatric patients of the pediatric and adolescent clinic in the timecourse after the beginning of the pandemic in order to better understand and monitor thedevelopment of antibody prevalence.

University of Wolverhampton

COVID-19 Health Professional Impact Study

Conditions: Coronavirus Infection, Severe Acute Respiratory Syndrome

The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources andstaff in the UK. Understanding the key risk factors associated with infection amongsthealthcare workers is essential for future pandemic response plans.Currently there are scarce data relating to the infection rates and associated factorsamongst healthcare workers in the United Kingdom (UK). Studies of infection rates inhealthcare workers have largely relied on the real-time reverse transcriptase-polymerasechain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice aslikely to succumb to Coronavirus infection, when compared to the general population andthose from Black and minority ethnic (BAME) backgrounds appear to be particularly atrisk.Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratorysyndrome coronavirus 2) antibodies provides seasonal or long term immunity to futureinfection.Therefore, this study aims to understand the current level of SARS-CoV-2 antibodypositivity and try to determine the likely risk to healthcare workers in the UK toCOVID-19 infection. This study hopes to find out whether certain individualcharacteristics will have an impact on likelihood of infection susceptibility andantibody response and determine the impact of the presence of antibodies on thelikelihood of future clinical infection over a 12 month period.The study involves an initial online survey and linkage to the recent antibody test, thena further online survey in 6 and 12 months' time. The data obtained will be linked todata that the Human Resources Department (HR) holds.Participants also have the option to partake in another antibody test at 6 and 12 months'time and linked to the data collected.

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.

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Status

  • Unknown status (29)
  • Active, not recruiting (14)
  • Recruiting (8)

Intervention Type

  • (-) Diagnostic Test (51)
  • Other (6)
  • Biological (1)

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