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Clinical Trials and Expanded Access

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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 7 of 7

University Hospital Tuebingen

NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression

Conditions: COVID-19

In this study (i) the host genome to identify susceptibility regions of infection, inflammation, and host defense, (ii) host response to Severe Acute Respiratory Syndrome-Corona-Virus-2 (SARS-CoV-2) infection, and (iii) viral sequence composition to define viral sequences which may be correlated with disease severity in addition to the metagenome of the throat swab will be analysed .

Direction des Soins de Santé de Base, Eshmoun Clinical Research Centre, Dacima Consulting

Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study

Conditions: COVID 19, BCG Vaccination

Covid-19 In Tunisia: AN Observational Cross-Sectional Registry Study

Agencia Costarricense de Investigaciones Biomedicas, Caja Costarricense de Seguro Social, Fundación INCIENSA (FUNIN), Ministerio de Salud de Costa Rica, Institutos Nacionales de Salud, USA Instituto Alemán del Cáncer, Agencia Costarricense de Investigaciones Biomedicas (ACIB)

Evaluation of the Immune Response to SARS-CoV-2 Among Patients With Covid-19 in Costa Rica

Conditions: COVID-19

Describe the immune response of patients affected by SARS-CoV-2, including an assessment of the types of antibodies elicited by the infection, specifc antibody titers for the different isotypes, evolution of the antibody response over time, protective efficacy and immune correlates of protection. investigate genetic determinants of Covid-19 and of the imune response to this condition. Finally, the study will investigate secondary infection rate and its determinants among household contacts of Covid-19 patients.

University of California, Irvine, Applied Biology, Inc.

COVID-19 In-vitro Diagnostic Test and Androgen Receptor Gene Expression

Conditions: COVID19, Androgen Receptor Gene Overexpression

This research study will evaluate the association of Androgen Receptor (AR) gene expression and COVID-19 disease severity and mortality. The research procedure involves collection of a single saliva sample which will be mailed to the participants by the study team. This saliva will be used in a COVID-19 Androgen Sensitivity Test (CoVAST) which will detect AR gene expression. Eligible participants are males, at least 18 years or older, and have tested positive for COVID-19.

Ricardo Pereira Mestre, Institute of Oncology Research (IOR), Istituto Cantonale di Patologia

HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients

Conditions: COVID19

The study includes 2 sub-projects. Sub-project 1: The aim is to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino. Sub-project 2: The aim is to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino.

CMC Ambroise Paré

Thymic Function in Patients With COVID-19

Conditions: COVID19

The main clinical manifestation associated with SARS-CoV-2 infection is an influenza-like illness that follows the infection of the respiratory tract. In a few percent of infected people, inflammation of the lungs leads to severe pneumonia that requires hospitalization, in intensive care units for the more severe cases. Despite intensive care, a fatal outcome occurs in 6% and 12% of women and men over 80 years of age hospitalized for severe COVID, respectively. Factors associated with a higher risk of death in patients with SARS-CoV-2 include age and low circulating lymphocyte counts. Significant lymphopenia is indeed frequently observed in patients with severe COVID-19 and both phenotypic and functional changes in antiviral T cells have been correlated with the severity of COVID-19. The thymus, the organ that produces T lymphocytes, undergoes progressive physiological involution with age. However, in the elderly, rare cases of thymic hyperplasia are reported in autoimmune diseases or cancers, or are observed in response to deep lymphopenia, whether or not associated with sepsis. This cohort of patients treated for a SARS-CoV-2 infection could allow to better understand the role of the thymus in this pathology.

Assistance Publique - Hôpitaux de Paris, Fonds IMMUNOV

Study of the Immunological and Virological Response of Patients With COVID-19 and Presenting an Asymptomatic or Pauci-symptomatic Form (AMBUCOV)

Conditions: COVID19, SARS-CoV-2

The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics. The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.

Status

  • Recruiting (7)
  • (-) Not yet recruiting (6)
  • (-) Enrolling by invitation (1)

Intervention Type

  • Drug (450)
  • Other (343)
  • Biological (140)
  • Diagnostic Test (123)
  • Behavioral (102)
  • Device (71)
  • Dietary Supplement (36)
  • Procedure (24)
  • Combination Product (19)
  • (-) Genetic (7)
  • Radiation (4)

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© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA