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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. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Industry SWOT Analysis
        2. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        3. FDA Patient Listening Sessions
        4. 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. Column 2
        1. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        2. Research
          1. About
          2. Cross-Sectoral Health Threats
          3. IMEDS
          4. Post Market Research
          5. RAISE
          6. Real World Data
          7. Regulatory Science Accelerator
        3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. 2024 Annual Public Meeting
      3. Events
      4. News
      5. Publications
  • 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 300 of 530

Columbia University

Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence

Conditions: COVID-19, Corona Virus Infection, SARS-CoV 2

The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is notknown how long after someone gets sick with COVID-19 and recovers that they can stillinfect other people. It is also not known how quickly people make antibodies against thevirus, which help clear infection from the body. The investigators will enroll 300 peoplewho had COVID-19 based on lab testing or confirmed exposure to participate. An additional25 participants who have never tested positive for COVID and have not had the vaccinewill be enrolled as negative controls. Participants will complete a survey at enrollment.The investigators will also collect blood, nose swab, saliva, stool, semen, and breastmilk to test for the virus. The investigators will ask participants to complete a surveyand give specimens up to 12 times over 24 months. This information will be used to studyhow long the virus can live in different parts of the body, antibody development, andpost-infectious complications. The investigators hope that this information will allowmedical and public health providers to make recommendations to better care for patientsin the convalescent phase of COVID-19 infection.

Imagine Institute

Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked

Conditions: Covid-19 Infection

To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRIand/or CT scan including cardiac functional evaluation and myocardial tissuecharacterization of COVID_19 related disease in pediatric patients with cardiacinvolvement.

Mesoblast International Sàrl

Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

Conditions: Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

The objectives of this intermediate-size expanded access protocol are to assess thesafety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.

Instituto Materno Infantil Prof. Fernando Figueira

Northeast COVID-19 and Pregnancy Study Group

Conditions: COVID19, Coronavirus Infection, Pregnancy Disease, Severe Acute Respiratory Syndrome

A prospective and retrospective cohort study. The objective will to determine thefrequency of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, toevaluate clinical and laboratory predictors of COVID-19 progression and to determine thefactors associated with adverse maternal and perinatal outcomes in healthcare centers intwo states of Northeast Brazil.The study will be conducted including pregnant andpostpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in sixhealthcare centers in the Northeast of Brazil. All pregnant and postpartum women withclinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternitytriage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward willbe included. The data will be collected in specific forms. The exams will be carried outby trained professionals within each institution.

University of California, Los Angeles

Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions

Conditions: Corona Virus Infection

This study will provide access to investigational anti-SARS-CoV-2 human convalescentplasma for pediatric patients with underlying medical conditions (cardiovascular disease,lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have hada high-risk exposure. Study participants will be transfused once with compatibleconvalescent plasma obtained from an individual who has recovered from documentedinfection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

Varian Medical Systems

Low-Dose Radiotherapy For Patients With SARS-COV-2 (COVID-19) Pneumonia

Conditions: COVID-19, SARS-COV2, Pneumonia

Low doses of radiation in the form of chest x-rays has been in the past to treat peoplewith pneumonia. This treatment was thought to reduce inflammation and was found to beeffective without side effects. However, it was an expensive treatment and was eventuallyreplaced with less expensive treatment options like penicillin.The COVID-19 virus has emerged recently, causing high rates of pneumonia in people. Theauthors believe that giving a small dose of radiation to the lungs may reduceinflammation and neutralize the pneumonia caused by COVID-19. For this study, the x-raygiven is called radiation therapy. Radiation therapy uses high-energy X-ray beams from alarge machine to target the lungs and reduce inflammation. Usually, it is given at muchhigher doses to treat cancers.The purpose of this study is to find out if adding a single treatment of low-dose x-raysto the lungs might reduce the amount of inflammation in the lungs from COVID-19infection, which could reduce the need for a ventilator or breathing tube.

Chinese University of Hong Kong

Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)

Conditions: COVID-19

The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate ofSARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow thepregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4)determine the risk and characteristics of vertical transmission; and 5) evaluate theplacental barrier, immune response and fetal damage in vertical transmission ofSARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and alaboratory-based study will be conducted to fulfil the 5 objectives.

University Hospital Southampton NHS Foundation Trust

SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer

Conditions: Cancer, COVID

Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universalinterventions to maintain and improve physical health, nutritional state andpsychological wellbeing in people with cancer who are following social distancingguidance: A COVID-19 targeted trial.Indication: Male or female participants, aged over 18 years old with suspicion orconfirmed diagnosis of cancer (does not require histological confirmation)Objective: To investigate the efficacy of remote multimodal universal interventionsdelivered via virtual clinics to improve physical function as measured by theEORTC-QLQ-C30.Secondary Objective:To investigate the efficacy of remote multimodal universal interventions delivered viavirtual clinics to improve emotional function, quality of life, participant activation(PAM), behaviour change and the effect it has on health economics (EQ-5D-5L).Exploratory Objective:Overall Survival and adherence to the intervention/advice using validated tools ordevelopment of a web-based toolkit.

Poudre Valley Health System

Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol

Conditions: COVID-19

A pilot study to investigate the effects of the prone positioning (PP) on hospitalpatients diagnosed with COVID-19 pneumonia.Investigators that early self-proning may prevent intubation and improve mortality inpatients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2).Up to 100 participants with a primary diagnosis of confirmed COVID-19 pneumonia will beenrolled to the study.All participants will be screened and those that meet inclusion and exclusion criteriawill be enrolled to one of two groups: one with prone positioning (on the belly) and theother with standard supine positioning (on the back). The patient and nursing staff willmonitor times spent in various positions.Outcome measures include incidence of intubation, max oxygen requirements, length ofhospital stay, ventilator-free days, worsening of oxygenation saturation, and mortality.

Karolinska Institutet

Cardiovascular Risk Factors and Severe COVID-19. A Nationwide Registry-based Case-Control Study

Conditions: COVID-19

In this study we cross-reference several nationwide high-quality Swedish registers inorder to study risk factors for severe Covid-19 outcomes.

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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