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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 6 of 6

University Hospital, Toulouse

Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection

Conditions: COVID-19

There is a pandemic in the world by COVID-19. Currently, the pharmacological curative orprophylactic treatments for this infection are not known. Recent studies have suggestedthat Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. Themain objective of this study is to assess in patients with autoimmune disease treatedwith long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had anindependent protective effect on the risk or the severity of infection with COVID-19.

University Health Network, Toronto

A Research Platform to Screen Healthcare Workers- Coordinated Approach to Pandemic Trials of COVID-19

Conditions: Healthcare Worker, COVID19

Recent studies have shown that some individuals may be asymptomatic but continue to shedthe COVID-19 virus. These individuals may represent a population that can unknowinglytransmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community orfrom possibly infected patients. It is important to gather data with respect to this tofurther understand the prevalence of asymptomatic carriage in individuals who work inresearch facilities, offices and clinical areas of hospitals and researchfacilities/institutes since this has important implications for infection control, aswell as staff and patient safety. The purpose of this study is to test whether aproportion of these individuals may be asymptomatic shedders of the COVID-19 virus.

University of Wolverhampton

COVID-19 Health Professional Impact Study

Conditions: Coronavirus Infection, Severe Acute Respiratory Syndrome

The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources andstaff in the UK. Understanding the key risk factors associated with infection amongsthealthcare workers is essential for future pandemic response plans.Currently there are scarce data relating to the infection rates and associated factorsamongst healthcare workers in the United Kingdom (UK). Studies of infection rates inhealthcare workers have largely relied on the real-time reverse transcriptase-polymerasechain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice aslikely to succumb to Coronavirus infection, when compared to the general population andthose from Black and minority ethnic (BAME) backgrounds appear to be particularly atrisk.Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratorysyndrome coronavirus 2) antibodies provides seasonal or long term immunity to futureinfection.Therefore, this study aims to understand the current level of SARS-CoV-2 antibodypositivity and try to determine the likely risk to healthcare workers in the UK toCOVID-19 infection. This study hopes to find out whether certain individualcharacteristics will have an impact on likelihood of infection susceptibility andantibody response and determine the impact of the presence of antibodies on thelikelihood of future clinical infection over a 12 month period.The study involves an initial online survey and linkage to the recent antibody test, thena further online survey in 6 and 12 months' time. The data obtained will be linked todata that the Human Resources Department (HR) holds.Participants also have the option to partake in another antibody test at 6 and 12 months'time and linked to the data collected.

Ankara University

Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19

Conditions: COVID 19

COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus namedas SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have adevastating effect on many organs, the respiratory tract is particularly affected. In thecourse of the disease, a wide clinical spectrum is observed, from flu-like illness tolung failure. Some of the patients who survived the disease continue to have problemssuch as shortness of breath, fatigue, decrease in walking distance, decrease inparticipation in daily life activities. These problems suggest that the effects onrespiratory and cardiac functions continue even after the disease ends. This study wasdesigned to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.

London Health Sciences Centre

Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection

Conditions: COVID19

This is a longitudinal study of the long-term impact of COVID-19 on the lungs.Participants will be followed over a period of up to 4 years and impacts of COVID-19 onthe lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarizedxenon-129, pulmonary function tests, exercise capacity, computed tomography imaging andquestionnaires.

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.

Status

  • Active, not recruiting (3)
  • Unknown status (2)
  • Recruiting (1)

Intervention Type

  • (-) Diagnostic Test (6)
  • (-) Other (6)

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