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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

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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. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.

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 50 of 530

M.D. Anderson Cancer Center

Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)

Conditions: Covid-19 Infection

This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus thatcauses the disease COVID-19. This may help to improve testing for COVID-19.

Hull University Teaching Hospitals NHS Trust

Feasibility, of Tele-rehabilitation Following COVID-19

Conditions: Pulmonary Disease

Since initial reports of a novel coronavirus emerged from Hubei province, China, theworld has been engulfed by a pandemic with over 3 million cases and 225,000 deaths by30th April 2020. Health care systems around the world have struggled to cope with thenumber of patients presenting with COVID-19 (the disease caused by the SARS-CoV-2 virus).Although the majority of people infected with the virus have a mild disease, around 20%experience a more severe illness leading to hospital admission and sometimes requiretreatment in intensive care. People that survive severe COVID-19 are likely to havepersistent health problems that would benefit from rehabilitation.Pulmonary rehabilitation (PR) is a multidisciplinary program which is designed to improvephysical and social performance and is typically provided for people with chronic lungconditions. PR courses typically last 6-12 weeks with patients attending classes once ortwice weekly and consist of exercise and education components. PR is known to improvesymptoms (e.g. breathlessness), quality of life and ability to exercise in those withlung conditions. Breathlessness is a very common symptom reported by people presenting tohospital with COVID-19 and loss of physical fitness will be very common. Using existingpulmonary rehabilitation programmes as a model, we have developed a tele-rehabilitationprogramme (a programme that will be delivered using video link to overcome the challengesfaced by social distancing and shielding advice) for people that have been critically illwith COVID-19. In order to prove whether people benefit from this tele-rehabilitationprogramme after being admitted to hospital following COVID-19 we would need to perform alarge clinical trial. However, before doing this it is important for us to answer somekey questions: - How many people that have been admitted to hospital and needed intensive care treatment for COVID-19 still report breathlessness, fatigue, cough and limitation of activities after being discharged from hospital? - Is it possible to recruit these people to a trial of tele-rehabilitation after hospital discharge? - Are people willing and able to perform tele-rehabilitation in their own home using video-link to connect with their therapist? - Are there other rehabilitation needs that are commonly encountered by people requiring intensive care treatment for COVID-19 that could be addressed by tele-rehabilitation that the programme doesn't currently address? Investigators will perform a small study called a feasibility trial to answer these questions and gather some early information about possible benefits of tele-rehabilitation. Based on our understanding of other similar diseases, doctors and therapists think that people will benefit from rehabilitation after COVID-19. The investigators therefore want to test a trial design that makes sure that everyone gets the treatment. This type of trial is called a feasibility, wait-list design randomised controlled trial. People with breathlessness and some limitation of activities will be selected at random to receive tele-rehabilitation within 2 weeks or to wait 6-8 weeks before starting. how many people were eligible to take part, how many agreed to take part and the symptoms and rehabilitation needs that they have will be assessed. Investigators will then monitor symptoms and ability to exercise at the start and end of the trial and before and after tele-rehabilitation.

Imperial College London

Artificial Intelligence-assisted Diagnosis and Prognostication in COVID-19 Using Electrocardiograms

Conditions: Coronavirus

Coronavirus Disease 2019 (COVID-19) has been widespread worldwide since December 2019. Itis highly contagious, and severe cases can lead to acute respiratory distress or multipleorgan failure. On 11 March 2020, the WHO made the assessment that COVID-19 can becharacterised as a pandemic. With the development of machine learning, deep learningbased artificial intelligence (AI) technology has demonstrated tremendous success in thefield of medical data analysis due to its capacity of extracting rich features fromimaging and complex clinical datasets. In this study, we aim to use clinical datacollected as part of routine clinical care (heart tracings, X-rays and CT scans) to trainartificial intelligence and machine learning algorithms, to accurately predict the courseof disease in patients with Covid-19 infection, using these datasets.

E-MO Biology Inc

Polio Vaccine (IPV) for SARS-CoV-2 and Prevention of Coronavirus Disease (COVID-19)

Conditions: SARS-CoV-2

A total of 300 healthy volunteers between the ages of 18 and 80 with no previous historyof COVID-19 will be entered into the study and will receive IPV by injection on Day 1.Blood specimens collected pre-inoculation will be tested for cross-reactivity topoliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected onDay 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus andSARS-CoV-2.The number of subjects with an immune response to SARS-CoV-2 antigens followinginoculation with IPV will be summarized.

Fondazione Epatocentro Ticino

Methylene Blue Treatment of COVID-19

Conditions: SARS-COV2

Despite enormous progress in understanding COVID-19, there is little evidence that asolution, therapeutic or preventive, is close to being achieved. Repurposing of wellknown, widely available drugs represent an attractive approach to speed up availabilityof active treatments. Such substances as i.e. hydroxychloroquine and others, are alreadyunder investigation and in widespread off label use. For many reasons Methylene blue(MB), the oldest synthetic substance in medicine (1876 synthesized by BASF) is such apromising candidate for an active treatment against SARS-CoV-2 infected people and forCOVID-19 patients.

Jiangsu Province Centers for Disease Control and Prevention

Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)

Conditions: COVID-19

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safetyand immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthypopulation aged 18 years and older. After randomization, the trial for each subject willlast for approximately 13 months. Screening period is 1 week prior to randomization (Day-7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will begiven intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 yearsold will be enrolled in adult group, and healthy elderly population who are >59 years oldwill be enrolled in elderly group. After adult group completes the follow-up 7 days afterfirst vaccination, elderly group will be recruited.

Lebanese American University Medical Center

Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC

Conditions: COVID19

COVID-19 infection was shown to cause endothelial dysfunction .At the level of the endothelium the pathophysiological mechanisms have been hypothesizedand were divided into pro-coagulant, pro-inflammatory, anti-fibrinolytics, impairedbarrier function, vasoconstrictor and pro-oxidant. So far, the pro-coagulant andpro-inflammatory pathways have been studied and as a result dexamethasone andanticoagulation became part of the standard therapies for the disease. However, so far,no RCT has been evaluated on targeting the vasoconstrictive and antioxidant pathways withan aim of revealing clinical benefit.So, with this trial we intend to provide a regiment composed of several medications wehypothesize will act on several downstream pathways that would improve endothelialfunction primarily via the increase in NO production and release.At the time of this proposal there has been no randomized trials evaluating or testingthe use of cardiovascular drugs targeting endothelial dysfunction in COVID-19 patients.As previously noted there has been a call to study these drugs and their effect after astrong research regarding their theorized effectiveness. For evidence, there was arecently published meta-analysis evaluating the role of statins in COVID-19 withpreliminary findings suggested a reduction in fatal or severe disease by 30% anddiscredited the suggestion of harm, that emphasized on the need of well-designedrandomized controlled trial to confirm the role of statins in COVID-19 patients.Our study would help determine the potential therapeutic effect of the endothelialprotocol as adjunct to mainstream management. This study seeks to further our knowledgein treating COVID-19 to ultimately improve clinical outcomes and reduce complications.

Hellenic Cooperative Oncology Group

Head and Neck cancERs International cOviD-19 collabOraTion

Conditions: Head and Neck Cancer, COVID19

To develop an International registry on head and neck cancer patients infected withCOVID-19

Longeveron Inc.

Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER)

Conditions: ARDS, Human, COVID19

A Phase I, double- blinded, randomized, placebo- controlled study to test the safety ofLomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome(ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant frominfluenza virus infection.

VA Office of Research and Development

Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs

Conditions: COVID-19, Chronic Lung Diseases

This is study is comprised of three approaches. First, the investigators will conduct aretrospective cohort study to determine factors associated with COVID-19 severity andcomplications and understand COVID-19 outcomes, including all-cause mortality,post-discharge events, and impacts of rehabilitation services (third aim). The second aimis a mixed-method study and follows COVID-19 patients with repeated surveys to determinepatient-reported functional outcomes, health recovery, and rehabilitation needs afterCOVID-19. The investigators will recruit patients and their informal caregivers forinterviews to assess their function and rehabilitation needs.

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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