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COVID-19 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.

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 159 of 159

Medical University of Graz

COVID-19 and the Developement of Phobic Fears of Disease

Conditions: COVID19

A lot of people suffer from phobias. Phobias concerning certain diseases are not rare.This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able torise phobias in people and if those with preexisting phobias or fears were more likely todevelop a phobia concerning COVID. It will look at different subtypes - physicians,medical staff, general public (not medically affiliated) and patients with psychiatricdisorders.

Vanderbilt-Ingram Cancer Center

COVID-19 and Cancer Consortium Registry

Conditions: COVID-19, Invasive Malignancy (Any Type)

In this study we will collect granular information on cancer patients infected withCOVID-19, as rapidly as possible. The mechanism for collection of this information is ade-identified centralized registry housed at Vanderbilt University Medical Center, withdata donations from internal and external health care professionals.

University of California, San Diego

Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to COVID-19

Conditions: COVID-19, Cancer

The primary objective of this research study is to assess Radiation Oncology healthcareproviders (i.e. faculty, residents and advanced practice providers (APPs) implementationand perception of telehealth for on treatment patients in lieu of in person on treatmentvisits during standard of care radiotherapy during COVID-19.

KK Women's and Children's Hospital

Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

Conditions: COVID-19

The overall objective of this project is to develop an emergent treatment protocol usingadoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis isthat SARS-CoV-2 specific T cells from convalescent donors who have recovered fromCOVID-19 can be manufactured expeditiously for the treatment of severe SARS-CoV-2infections.

Neuroganics LLC

COVID-19 Diagnostic Self-testing Using Virtual Point-of-care

Conditions: Communicable Disease, COVID-19, SARS-COV2, Infectious Disease, Coronavirus, Virus

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g.immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigentests, like Turklab Test-It COVID-19 Home Test, AllBio Science Inc. and ArtronLaboratories Inc. rapid COVID-19 antigen tests in order to judge their clinical accuracycompared to Centers for Disease Control (CDC)-recommended molecular genetic testing andclinical diagnosis. Second, it is our goal to determine if self-testing assisted byCOVIDscanDX mobile device camera acquisition software platform and telemedicineclinical/technical support (virtual point-of-care) improves the ease of use and immediateinterpretation of the tests, thus making self-testing comparable in accuracy and safetyto testing in a clinical setting. Third, we are testing antibodies to SARS-CoV-2 afterdiagnosis with COVID-19 or following vaccination to measure the onset and time course ofdetectable antibodies from finger-stick blood drops and rapid antibody lateral flowtests. The overall purpose of the study is to dramatically increase the capacity ofCOVID-19 testing by establishing the safety, ease-of-use and validity of self-testingassisted by mobile device imaging and telemedicine remote support and provide evidence ofantibody time-course response to vaccination.

Centro Nacional de Investigaciones Oncologicas CARLOS III

Clinical Trial to Evaluate Efficacy of 3 Types of Treatment in Patients With Pneumonia by COVID-19

Conditions: COVID-19 Pneumonia

In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease,identifying treatment options is critical at this time to control the disease outbreak.For this, we have designed a phase II trial of efficacy and safety with 3 branches ofdifferent combinations of treatment to identify which is the best early treatment optionfor patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options asearly as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is noapproved vaccine for the disease and the treatments being used are not specificallydesigned for the SARS-CoV-2 virus, but are different groups of drugs used for otherpathologies with mechanisms of action that justify their use because they inhibit entryof the virus into virus cells or proteases.The study aims to compare Imatinib 400mg, Baricitinib 4mg or supportive treatment,administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment.Patients who meet inclusion criteria and do not have any exclusion criteria will berandomized to receive open treatment 1:1:1

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

Qilu Hospital of Shandong University

Bevacizumab in Patients With Severe Covid-19

Conditions: COVID-19 Pneumonia

The novel coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019,which causes epidemic worldwide. Novel coronavirus disease (COVID-19) causes acute lunginjury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severeCOVID-19. Pulmonary edema is the key detrimental feature of ALI/ARDS. Autopsy of patientsdied from COVID-19 reported that, pulmonary mucus exudation was more severe and obviousthan SARS infection. Pulmonary CT scanning and pathological findings also suggest thatpulmonary edema caused by inflammatory exudation is a distinguished feature of COVID-19.Vascular endothelial growth factor (VEGF), also known as vascular permeability factor(VPF), is known as the most potent factor to increase vascular permeability, with theinduction effect 50,000 times stronger than histamine. Bevacizumab is an anti-VEGFrecombinant humanized monoclonal antibody, which has been used in anti-tumor treatmentsince 2004, with considerable reliability and clinical safety. This trial will providehigh level evidence to answer whether bevacizumab is efficacy and safe medication forpatients with severe COVID-19.

Università Vita-Salute San Raffaele

COVID-19 Patients Characterization, Biobank, Treatment Response and Outcome Predictor

Conditions: Coronavirus Infections

Collection and analysis of demographic, clinical, radiographic and laboratorycharacteristics of CoViD-19 patients to identify predictors of disease severity,mortality and treatment response, and to identify subgroup of patients that might benefitfrom specific therapeutic interventions

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Status

  • Unknown status (76)
  • Recruiting (48)
  • Active, not recruiting (27)
  • Not yet recruiting (5)
  • Enrolling by invitation (3)

Intervention Type

  • (-) Other (159)
  • Drug (17)
  • Biological (15)
  • Behavioral (6)
  • Diagnostic Test (6)
  • Procedure (4)
  • Dietary Supplement (1)
  • Radiation (1)

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