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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 200 of 530

National Cancer Institute (NCI)

Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia

Conditions: Covid-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed

This is a phase I trial followed by a phase II randomized trial. The purpose of phase Istudy is the feasibility of treating patients with acute respiratory distress syndrome(ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stemcells (MSC). The purpose of the phase II trial is to compare the effect of MSC withstandard of care in these patients. MSCs are a type of stem cells that can be taken fromumbilical cord blood and grown into many different cell types that can be used to treatcancer and other diseases. The MSCs being used for infusion in this trial are collectedfrom healthy, unrelated donors and are stored and grown in a laboratory. Giving MSCinfusions may help control the symptoms of COVID-19 related ARDS.

Assiut University

Comorbidities And Complications Associated With Covid-19 Infection

Conditions: COVID19

To evaluate the spectrum of comorbidities and complications and its impact on theclinical outcome in hospitalized patients with coronavirus disease 2019 (COVID-19).

Centre Hospitalier Universitaire, Amiens

Physiopathology and Sequelae of COVID-19 Infection

Conditions: COVID19, TSH, Cortisol

The data obtained from Covid-19 infections seem to suggest that the immunogenesis ofCovid-19 could in some cases be the result of immune dysregulation. On the other hand,endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal,and hypothalamus). These disorders are autoimmune or linked to degeneration.The main objective is to assess the thyroid function (thyrotropic axis) as well as thecorticotropic adrenal function of patients who have had Copvid-19 pneumonia. Thesecondary objectives is to describe the pathophysiological mechanisms of pulmonary andvasculothrombotic involvement of Covid-19

Centre Hospitalier Universitaire, Amiens

COVID-19 Serology and Immunosenescence

Conditions: COVID19, Geriatric Medicine, Seroconversion, Immunosenescence

This study aims to determine how long COVID-19 neutralizing antibodies can be detected inan elderly institutionalized population presenting fragility factors.This study also aims to stratify seroconversion by immunological profiles of the elderlypatients residing in the EHPAD. This stratification requires the measurement ofimmunological marker levels already described in immunosenescence and also involved inthe development of certain chronic infectious diseases more common in the elderlypopulation. This analysis will enable the investigators to describe an immunological,clinical and biological profile representing a patient who has developed an immunityagainst COVID 19. It will also help the investigators to understand the differentmechanisms leading to a reduced immune response after a potential administration of avaccine. Finally, it will help describe the immune profiles of elderly residents whopresented with non-severe forms of COVID-19.

Universidad Politecnica de Madrid

Active Pregnancy Against COVID-19

Conditions: Pregnancy Complications, Pregnancy, High Risk, Pregnancy Induced Hypertension, Newborn Morbidity, Fetal Growth Retardation, Fetus Disorder, Weight Gain, Maternal, Maternal-Fetal Relations

Historically and traditionally, the recommendations related to physical exercise duringpregnancy have been based more on moral or cultural issues than on scientific evidence.During some phases of history, pregnancy has meant a period of seclusion for women (notonly physical). One of the adverse consequences has been the common recommendation ofrest as a general rule for pregnant women.Scientific evidence from recent years has achieved a better understanding of the processof pregnancy and childbirth as well as maternal and fetal responses to exercise.Currently, both from a scientific and clinical/obstetric point of view, there is no doubtabout the benefits of an active pregnancy for entire body of pregnant woman, and even herchild. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation,even more with important associated complications during pregnancy and postpartum period.Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in thissense the necessary measures taken by the different administrations, especially in termsof confinement causes (from now on) a large number of complications affecting differentpopulations. In summary a complex situation without established prevention strategiesexists.The pregnant population is, due to the nature of the gestation and delivery process, oneof the population groups with the highest risk of adverse outcomes and associatedcomplications and whose consequences include the mother, fetus, newborn and evenchildren. According to an important body of scientific literature and based on anepigenetic effect, the intrauterine environment can be a determining factor for thefuture human being to evolve regardless of complications and pathologies (cardiovascular,metabolic, psychic, emotional). This is demonstrated by numerous recent scientificevidences that confirm the unfortunate association between an adverse intrauterineenvironment (due to various factors) and observable postnatal pathologies in infants.In addition, current publications report the large number and variety of alterations thatthe COVID-19 situation causes in pregnant women and that includes the entire femaleorganism. This complex situation does not only affect aspects of a physical orphysiological nature, but also psychic and emotional factors. In summary, a new state ofconfinement or similar situations in the near future (impossibility of groupings,distance between people), avoid during the daily life of pregnant women one of theimportant and recent recommendations made by the international scientific community: apregnancy physically active.This is especially relevant, due to the dangerous association between complications of apsychological or emotional nature during pregnancy with pre, peri and postnatal disorders(low birth weights, perinatal complications, altered and prolonged deliveries, etc.),which affect not only to the mother and can determine the health of the future humanbeing. According to the scientific literature and based on an epigenetic effect, theintrauterine environment can be a determining aspect in the health of the future humanbeing and the prevention of complications and pathologies (cardiovascular, metabolic,psychic, emotional). This is demonstrated by numerous and recent scientific evidencesthat confirm the unfortunate association between an adverse intrauterine environment (dueto various factors) and different pathologies during and after pregnancy.It is evident the change that COVID-19 and its effects will generate in the lifestyle ofthe pregnant population and the increased probability of suffering associated pathologiesin the next 24-36 months. No preventive actions have yet been planned in Spain and itspublic hospitals against the impact of COVID-19 on the quality of life of pregnant women.It is urgent to design and perform an adequate strategy of intervention for its possibleprevention. From the scientific point of view, the recommendations are clear andconcrete, an aerobic exercise program, designed and supervised by professionals from theSciences of Physical Activity and Sports, is the best option for pregnant women.In this sense, in the last 30 years, physical exercise has proven to have many benefitsfor pregnant women, without causing risks or adverse effects on maternal-fetalwell-being. This is confirmed by an important body of scientific literature ongestational physical exercise and its effects on pregnancy outcomes.

Centre Hospitalier le Mans

Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV

Conditions: SARS-COV2, COVID19

Since December 2019, China and then the rest of the world have been affected by the rapidspread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratorysyndrome coronavirus), the clinical expression of which is called Covid-19 (CoronavirusDisease 2019).It is estimated that around 20% of symptomatic patients will be severe enough to warranthospitalization, of which around 5% will be in intensive care.Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological,cardiovascular due to the infection or its care. There is also a psychological and socialimpact of the infection or of the care that should be measured.In this context, investigator will assess the physical and psychological complaints ofpatients who have presented a severe form of SARS-CoV-2 infection.The final objective being to identify the needs to offer follow-up adapted to thisemerging pathology.

ClinAmygate

The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice

Conditions: COVID19

The study explore the relationship between COVID-19 and the induction of autoimmunediseases.

Assistance Publique - Hôpitaux de Paris

Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)

Conditions: COVID19, Arterial Stiffness, Endothelial Dysfunction, Diastolic Dysfunction

The purpose of the study is to evaluate the presence of early vascular aging 6 months and12 months after COVID-19 infection.

Karolinska Institutet

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

Conditions: Multiple Myeloma

Prospective, single center, randomized, open label, parallel group, 2-arm study assessingthe clinical benefit in term of enhancement of overall response rate of Isatuximab incombination with CellProtect as compared to Isatuximab for the treatment of patients withnewly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) asmaintenance after SCT.

Jordi Alonso

MIND/COVID-19: Mental Health Impact and NeeDs Associated With COVID-19: a Comprehensive National Evaluation in Spain

Conditions: COVID19, Mental Health Disorder, Mental Health Conditions

The aim of the proposed project is to provide a comprehensive assessment of the mentalhealth impact of the ongoing COVID-19 outbreak in Spain. A prospective cohort study ofthree groups will be conducted: (1) COVID-19 cases or close contacts recently isolated orquarantined; (2) healthcare workers; (3) adult general population.Recruitment through epidemiologic surveillance services, hospitals, primary care centersin 6 Spanish Autonomous Communities (groups 1 & 2) and a random sample of individualsusing telephone numbers as the sampling frames(group 3). Web-based surveys or telephoneinterviews at baseline and 6-month follow-up assess: current living and employmentstatus; COVID-19 infection status; mental health (post-traumatic stress, panic,depression, anxiety, alcohol and substance use, suicidality; services use); psychologicalfunctioning; general health status and quality of life. Specific modules focus onisolation or quarantine (group 1) and care for COVID-19 patients (group 2). Shortbi-weekly brief follow-up surveys among groups 1 & 2 will provide additional assessmentof main outcomes in the two months following baseline assessment.

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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
© Reagan-Udall Foundation for the FDA