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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 520 of 530

Tongji Hospital

The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19

Conditions: Gynecological Cancer

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19)emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. Thedelayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection,is an increasing serious problem. Here the investigators investigate the safety ofchemotherapy for patients with gynecological malignancy in Wuhan, the center of high-riskregions of COVID-19.

Hospital General Universitario Morales Meseguer

NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure

Conditions: Respiratory Failure, COVID-19

Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure inpatients with COVID-19 associated respiratory failure.Propose adaptations to HACOR score based on the "state of art" of COVID-19

University of Karachi

A Clinical Trial of Gargling Agents in Reducing Intraoral Viral Load Among COVID-19 Patients

Conditions: COVID-19

Pakistan is a resource restraint country, it's not possible to carry out coronavirustesting at mass scale. Simple cost effective intervention against the present pandemic ishighly desirable.For patients: Identifying an antiviral gargle that could substantially reduce thecolonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viralload. Such reduction in the viral load through surface debridement could aid theeffective immune response in improving the overall symptoms of the patients.For dentists: This study is important because the nature of the dental professioninvolves aerosol production, carrying out dental work on asymptomatic patients carryingcoronavirus puts the entire dental team at a great risk of not only acquiring theinfection but also transmitting it to the others. Antiviral gargles could be used bydentist and their auxiliaries as prophylaxis.For physicians and nurses: The risk of morbidity and mortality is high among physiciansand nurses involved in the screening and management of Covid-19 patients. Globally, over215 physicians and surgeons have died while taking care of Covid-19 patients. The causeof death is attributed to high exposure of viral load. The antiviral gargles and nasallavage can decrease the fatalities among doctors and nurses.Thus, patients, physicians, nurses and dentists, all could be benefited with thisfindings of this study.

Hospices Civils de Lyon

Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

Conditions: CoV2 Positive Caregivers

Covid-SER is a prospective multi-center study for the evaluation of diagnosticperformance of available serological tests

Institut National de la Santé Et de la Recherche Médicale, France

French COVID Cohort

Conditions: Coronavirus Infections

Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the SARS, MERS and other novel coronavirus, novel influenza viruses, virusescausing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the centralnervous system (CNS) such as TBEV & Nipah require investigation to understand pathogenbiology and pathogenesis in the host. Even for known infections, resistance toantimicrobial therapies is widespread, and treatments to control potentially deleterioushost responses are lacking.In order to develop a mechanistic understanding of disease processes, such that riskfactors for severe illness can be identified and treatments can be developed, it isnecessary to understand pathogen characteristics associated with virulence, thereplication dynamics and in-host evolution of the pathogen, the dynamics of the hostresponse, the pharmacology of antimicrobial or host-directed therapies, the transmissiondynamics, and factors underlying individual susceptibility.The work proposed here may require sampling that will not immediately benefit theparticipants. It may also require analysis of the host genome, which may reveal otherinformation about disease susceptibility or other aspects of health status.

Sanofi

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Conditions: Plasma Cell Myeloma

Primary Objectives: - Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMMSecondary Objectives:Safety run-in Part: - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal chromosomal subtype on participant outcomeRandomized Phase 3 Part:Key Secondary Objectives:To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survivalOther Secondary Objectives:To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Impact of abnormal chromosomal subtype on participant outcome - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)

Shenzhen Geno-Immune Medical Institute

Immunity and Safety of Covid-19 Synthetic Minigene Vaccine

Conditions: Pathogen Infection Covid-19 Infection

In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke outin Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratoryfailure and died, making it imperative to develop a safe and effective vaccine to treatand prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome andsearch for potential immunogenic targets, a synthetic minigene has been engineered basedon conserved domains of the viral structural proteins and a polyprotein protease. Theinfection of Covid-19 is mediated through binding of the Spike protein to the ACEIIreceptor, and the viral replication depends on molecular mechanisms of all of these viralproteins. This trial proposes to develop and test innovative Covid-19 minigenesengineered based on multiple viral genes, using an efficient lentiviral vector system(NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells(DCs) and to activate T cells. In this study, the safety and efficacy of this LV vaccine(LV-SMENP) will be investigated.

Hudson Medical

Eculizumab (Soliris) in Covid-19 Infected Patients

Conditions: Coronavirus

Covid-19 has spread rapidly throughout the world causing widespread panic, death, andinjury. While this virus is the provocateur, it is often the patient's owndisproportionate immune response which deals the most devastating (and often fatal)damage. A specific part of the immune system, known as the complement, has been shown tocause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris(Eculizumab) will be used to modulate the activity of the distal complement preventingthe formation of the membrane attack complex. By modulating this portion of the immuneresponse, mortality can be halted while the patient has time to recover from the viruswith supportive medical care.

Shenzhen Geno-Immune Medical Institute

Safety and Immunity of Covid-19 aAPC Vaccine

Conditions: Treat and Prevent Covid-19 Infection

In December 2019, viral pneumonia (Covid-19) caused by a novel beta-coronavirus(SARS-CoV-2) broke out in Wuhan, China. Some patients rapidly progressed and sufferedsevere acute respiratory failure and died, making it imperative to develop a safe andeffective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailedanalysis of the viral genome and search for potential immunogenic targets, a syntheticminigene has been engineered based on conserved domains of the viral structural proteinsand a polyprotein protease. The infection of Covid-19 is mediated through binding of theSpike protein to the ACEII receptor, and the viral replication depends on molecularmechanisms of all of these viral proteins. This trial proposes to develop universalvaccine and test innovative Covid-19 minigenes engineered based on multiple viral genes,using an efficient lentiviral vector system (NHP/TYF) to express viral proteins andimmune modulatory genes to modify artificial antigen presenting cells (aAPC) and toactivate T cells. In this study, the safety and immune reactivity of this aAPC vaccinewill be investigated.

University of Alabama at Birmingham

Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19

Conditions: Coronavirus Infections, Pneumonia, Viral, Acute Respiratory Distress Syndrome

The scientific community is in search for novel therapies that can help to face theongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019.At present, there are no proven interventions to prevent progression of the disease. Somepreliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could havebeneficial effects on SARS-CoV-2 due to the genomic similarities between this twocoronaviruses. In this study we will test whether inhaled NO therapy prevents progressionin patients with mild to moderate COVID-19 disease.

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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