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Home
  • About
      1. Board of Directors
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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 180 of 530

Oslo University Hospital

"NORPLASMA" Covid-19 Convalescent Plasma Treatment Monitoring Study

Conditions: COVID

NORPLASMA COVID-19 includes both the production of convalescent plasma from approvedblood donors who have recovered from covid-19 (coronavirus disease 2019), and clinicalstudies to evaluate efficacy and safety of the treatment, as recommended by Europeanhealth authorities. Patients who receive convalescent plasma in a clinical setting willbe invited to participate in the monitoring study NORPLASMA MONITOR, where clinical dataabout safety and effect on clinical parameters including virus load and recovery timewill be collected and compared to european patients in a common database for the Europeancountries. The treated patients can be compared to a historical control group.

INSERM, Epopé team

Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns

Conditions: COVID19 Infection, Pregnancy Complications, Neonatal Complications

The purpose of this study is to characterize the incidence and clinical features of thematernal COVID 19 infection, as well as the associated morbidity of the mother and thechild, in the French context

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.

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.

Chelsea and Westminster NHS Foundation Trust

PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

Conditions: Coronavirus, Corona Virus Infection, COVID-19, 2019nCoV, 2019 Novel Coronavirus Infection

PHENOTYPE is an investigator-led, observational cohort study which aims to explore thelong-term outcomes of patients with COVID-19 infection and to identify potential riskfactors and biomarkers that can prognosticate disease severity and trajectory.

Imagine Institute

COVID-19 in PID Survey

Conditions: Primary Immune Deficiency, COVID

With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need tounderstand the impact of infection on immunodeficient individuals. Whilst co-morbidities(such as diabetes, cancer, arterial hypertension, heart disease...) have been documentedin people infected with SARS-CoV-2, there is currently no information on the consequencesand outcomes for individuals with primary immunodeficiencies (PID).Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui(CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of thenumber of affected PID patients and the impact of SARS-CoV-2 and directly focusing onobtaining this top level of information), we are launching the 2nd phase: "COPID19".COPID19 survey is a secured online GDPR compliant platform based in Paris (ImagineInstitute). It has been approved by the Paris-Necker-Enfants malades IRB and EthicsCommittee. However, this retrospective survey is designed for global distribution. Datacan be entered by a health care professional (mostly clinicians) through a personal loginand password.Each documenting person will have access to his/her own patients' data. COPID19 require agreater level of information than the 1st phase. The eCRF will be open to evolutionsdepending on progresses in our knowledge of this pandemic.

Sanofi

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

Conditions: Primary Progressive Multiple Sclerosis

Primary Objective:To determine the efficacy of SAR442168 compared to placebo in delaying disabilityprogression in primary progressive multiple sclerosis (PPMS)Secondary Objectives:To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magneticresonance imaging (MRI) lesions, cognitive performance, physical function, and quality oflife To evaluate safety and tolerability of SAR442168 To evaluate populationpharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety Toevaluate pharmacodynamics of SAR442168

Corporacion Parc Tauli

Intracorporeal Anastomosis in Laparoscopic Left Colectomy. Cohort Comparative Study

Conditions: Colon Cancer

OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection andanastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior toextracoprporeal resection and anastomosis, in terms of anastomotic leakage.BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary toinfection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced toadapt our surgical procedures in order to minimize exposure to the virus as much aspossible.Based on the recommendations in case of surgery in patients with highly contagious viraldiseases, the latest studies suggest minimally invasive accesses to minimize the risk ofcontagion. One of the proposed measures is the performance of intracorporeal anastomoses.Therefore, given the extensive experience of our center in minimally invasive surgery andstudies on the validation of intracorporeal anastomosis techniques in both laparoscopicsurgery of the right colon and rectum (TaTME), and the study of advantages that they canprovide to the patient, our intention is to apply it to surgery on the left colon, sigmaand upper rectum. Our hypothesis is that exteriorization of the colon through anaccessory incision increases the risk of tension at the mesocolon level, thus increasingthe risk of vascular deficit at the level of the staple area and it may increase the rateof anastomotic leakage. In this sense, studies that validate a standard technique ofintracorporeal anastomosis in left colon surgery and that demonstrate its benefit withrespect to extracorporeal anastomosis are lacking. We intend to describe a newintracorporeal anastomosis technique (ICA) that is feasible and safe for the patient andthat can be applied universally. Once the ICA technique is established, it will allow usto determine its non-inferiority compared to the standard technique performed up to nowwith extracorporeal anastomosis.METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinomawill be included into a prospective cohort and treated by laparoscopy with totallyintracorporeal resection and anastomosis. They will be compared with a retrospectivecohort of consecutive patients of identical characteristics treated by laparoscopy withextracorporeal resection and anastomosis, in the immediate chronological period.

Pfizer

Study of PF-07265807 in Participants With Metastatic Solid Tumors.

Conditions: Neoplasm Metastasis

A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 asMonotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors

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.

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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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