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Home
  • About
      1. Board of Directors
      2. Our Staff
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      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 400 of 530

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.

Soroka University Medical Center

Pegylated Interferon Lambda for Treatment of COVID-19 Infection

Conditions: COVID-19

A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administeredsubcutaneously once weekly, for up to two weeks (2 injections at most), in addition tostandard supportive care, compared to standard supportive care alone, in a population ofCOVID-19 infected patients.patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180mcg S.C + standard care (intervention arm) or standard care only (control arm).

VISIBLE PATIENT, E-MEDIA

Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure

Conditions: SARS-CoV-2 Infection, Respiratory Failure With Hypoxia

Automated quantification of the pulmonary volume impaired during acute respiratoryfailure could be helpful to assess patient severity during COVID-19 infection orperioperative medicine, for example.This study aim at assessing the correlation between the amount of radiologic pulmonaryalteration and the clinical severity in two clinical situation : 1. SARS-CoV-2 infections 2. Postoperative hypoxemic acute respiratory failure

Brigham and Women's Hospital

COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications

Conditions: COVID19, Thrombosis Embolism, DVT, Pulmonary Embolism, Myocardial Infarction, Stroke

Novel coronavirus 2019 (COVID-19) has emerged as a major international public healthconcern. While much of the morbidity and mortality associated with COVID-19 has beenattributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emergingdata suggest that disorders of coagulation, in particular hypercoagulability and venousthromboembolism (VTE), may represent an additional major, and possibly preventable,complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and TangN, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulationtesting results, especially markedly elevated D-dimer and FDP, have been associated witha poor prognosis in COVID-19 infection. We propose the following Electronic Health Record(EHR)-guided 10000-patient, retrospective observational cohort study to assess VTEincidence, risk factors, prevention and management patterns, and thrombotic outcomes inpatients with COVID-19 infection. In order to gain the valuable perspective of otherregional and national centers providing care for large populations of COVID-19, we havestarted a collaborative network with 5 additional sites which will provide us withde-identified data from 1000 patients each. These 5000 patients in addition to the5000-patient cohort we are enrolling within the Mass General Brigham Network willcomprise this study population.

ClinAmygate

Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up

Conditions: COVID19, Corticosteroids

Timing of of corticosteroids administration is very important in COVID19 cases for therecovery and decrease the mortality.

Columbia University

Mother-infant Bonding During COVID-19

Conditions: Child Development, Mother-Infant Interaction, Relation, Parent-Child

This study will assess whether the promotion of emotional exchange between mother andinfant during the first four months of life improves primarily mother-child earlyrelational health (ERH) and secondarily child neurodevelopmental and maternal mentalhealth outcomes. In prior research on preterm infants, a similar interventiondemonstrated increased quality of maternal caregiving behaviors and significantimprovements in premature infants' neurodevelopment across multiple domains, includingsocial-relatedness and attention problems. The goal of the emotional exchangeintervention is to help mothers provide appropriate stimulation crucial for social,emotional, and neurobehavioral development, by helping the mother and child becomeattuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternalsensitivity, and mother-child emotional connection will be compared between two groups:one receiving newborn parenting education and the other undergoing facilitated emotionalexchange. Assessments will involve videos of mother-infant interactions during eachintervention session and follow-up surveys conducted as part of a linked InstitutionalReview Board-approved study. Data collected in this study will contribute tounderstanding the underlying mechanisms of mother-infant interactions and their role inshaping optimal neurodevelopmental trajectories for infants and maternal mental health.

Case Western Reserve University

S-Nitrosylation Therapy of COVID-19

Conditions: SARS-CoV2 Infection, COVID19

The primary objective of this study is to provide expanded access of S-nitrosylationtherapy for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2)infection.

ClinAmygate

Anosmia and / or Ageusia and Early Corticosteroid Use

Conditions: COVID19, Anosmia

Time to recover of Anosmia and / or ageusia and early corticosteroid use

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.

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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