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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 20 of 51

Sanofi

RSV Burden in Outpatient Settings

Conditions: RSV Infection, Children, Only, Outpatient, Bronchiolitis, Otitis Media, Pneumonia

Strengthening outpatient low respiratory tract infection surveillance to document theburden of Respiratory Syncytial Virus (RSV)

Palas GmbH

Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Conditions: SARS-CoV-2 Infection, COVID19

The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe AcuteRespiratory Syndrome Corona Virus 2) positive and negative children and adults with theResp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratoryaerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established.Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive andnegative participants (children and adults) will be conducted. In addition to themeasurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratoryinflammatory markers will be analyzed.

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.

Lahore General Hospital

Waxing and Waning of Serum SARS CoV-2-IgG Level in COVID-19 Exposed Population

Conditions: COVID19

This study will define the kinetics of IgG responses to both N and S proteins in thesubjects who suffered from COVID 19 and then had recovered and those who were previouslyundiagnosed but were seropositive. These subjects will be followed for four months toevaluate the levels of antibodies in these people.

Assistance Publique - Hôpitaux de Paris

Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)

Conditions: COVID19, Arterial Stiffness, Endothelial Dysfunction, Diastolic Dysfunction

The purpose of the study is to evaluate the presence of early vascular aging 6 months and12 months after COVID-19 infection.

TMC HealthCare

Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins in COVID-19 Patients

Conditions: COVID-19, SARS-CoV-2 Infection

SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negativelyimpacted global health and requires more research to develop better tests and to improvedisease treatment.The purpose of this research is to aid in the testing effort by collecting samples frompeople who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samplesyou provide will be used investigationally by INanoBio to develop a test to determinewhen antibodies against various SARS-CoV-2 proteins are detectable.Up to approximately 80 subjects of all ages with either a suspected or lab-confirmeddiagnosis of COVID-19 will take part in this research.

Swiss School of Public Health (SSPH+)

COVID-19: Longitudinal Study of Seroprevalence of SARS-CoV-2 Antibodies and Development of Immunity in School Children

Conditions: SARS-CoV 2, COVID-19

There is a lack of knowledge about how many children are infected with SARS-CoV-2, howoften they are asymptomatic, and how long the immunity persists.The main purpose of this study is to measure antibodies to SARS-CoV-2, symptoms, and riskfactors in a representative cohort of children and adolescents in the canton of Zurich,Switzerland, shortly after re-opening of the school system and thereafter. The study alsoinvestigates antibodies to SARS-CoV-2 in parents of the children and school personnel.

Bernhoven Hospital

Influence of COVID-19 on Vascular Endothelial Function

Conditions: COVID, Vascular; Damage

Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2could result in endothelial dysfunction with increased risk of arterial thrombotic eventsby downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelialfunction can be easily and non-invasively determined by carotid artery reactivity (CAR)testing.Objective: To investigate the predictive value of endothelial dysfunction, measured bycarotid artery reactivity testing, for 1-year cardiovascular events in patients with pastCOVID-19 infection.Study design: A prospective observational longitudinal cohort study.Study population: Patients recovered from confirmed infection with SARS-CoV2.Main study parameters/endpoints: macrovascular endothelial function measured by carotidartery reactivity testing.

Children's Hospital Medical Center, Cincinnati

Repeated Employee Testing for Understanding Our Recovery to Normal

Conditions: COVID-19

The purpose of this research study is 1) to conduct a prospective longitudinalsurveillance research trial, enrolling up to 200 CCHMC employees as they come back towork, and then following their clinical and laboratory parameters for up to 12 months;and 2) to support the ongoing development of diagnostic techniques for COVID-19. Theoverall goal is to investigate patterns of SARS-COV-2 infection, including immunologicalrecovery and genetic risk factors, among CCHMC employees to better understand how tosafely reintroduce the CCHMC work force back into their normal routines.

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Status

  • Unknown status (29)
  • Active, not recruiting (14)
  • Recruiting (8)

Intervention Type

  • (-) Diagnostic Test (51)
  • Other (6)
  • Biological (1)

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© Reagan-Udall Foundation for the FDA