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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. 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 40 of 254

Lebanese American University Medical Center

Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC

Conditions: COVID19

COVID-19 infection was shown to cause endothelial dysfunction .At the level of the endothelium the pathophysiological mechanisms have been hypothesizedand were divided into pro-coagulant, pro-inflammatory, anti-fibrinolytics, impairedbarrier function, vasoconstrictor and pro-oxidant. So far, the pro-coagulant andpro-inflammatory pathways have been studied and as a result dexamethasone andanticoagulation became part of the standard therapies for the disease. However, so far,no RCT has been evaluated on targeting the vasoconstrictive and antioxidant pathways withan aim of revealing clinical benefit.So, with this trial we intend to provide a regiment composed of several medications wehypothesize will act on several downstream pathways that would improve endothelialfunction primarily via the increase in NO production and release.At the time of this proposal there has been no randomized trials evaluating or testingthe use of cardiovascular drugs targeting endothelial dysfunction in COVID-19 patients.As previously noted there has been a call to study these drugs and their effect after astrong research regarding their theorized effectiveness. For evidence, there was arecently published meta-analysis evaluating the role of statins in COVID-19 withpreliminary findings suggested a reduction in fatal or severe disease by 30% anddiscredited the suggestion of harm, that emphasized on the need of well-designedrandomized controlled trial to confirm the role of statins in COVID-19 patients.Our study would help determine the potential therapeutic effect of the endothelialprotocol as adjunct to mainstream management. This study seeks to further our knowledgein treating COVID-19 to ultimately improve clinical outcomes and reduce complications.

Hellenic Cooperative Oncology Group

Head and Neck cancERs International cOviD-19 collabOraTion

Conditions: Head and Neck Cancer, COVID19

To develop an International registry on head and neck cancer patients infected withCOVID-19

Assiut University

CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction

Conditions: Myocardial Infarction

To compare myocardial injury in COVID 19 patients presented with myocardial infarctionand non COVID Patients presented with myocardial infarction evaluated with CMR

Augusta University

[COVID-19] Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse

Conditions: COVID19

The purpose of this study is to test the effectiveness of prophylactic mouth rinses inreducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This researchwill guide dental and medical providers on best practices to be performed prior to dentaland medical procedures involving the oral cavity.

Bahçeşehir University

Investigation the Effect of Montelukast in COVID-19

Conditions: COVID-19, SARS-CoV-2

Small molecule inhibitors have previously been investigated in different studies aspossible therapeutics in the treatment of SARS-CoV-2. In the current drug repurposingstudy, the investigators identified the leukotriene (D4) receptor antagonist Montelukastas a novel agent that simultaneously targets two important drug targets of SARS-CoV-2.The investigators initially demonstrated the dual inhibition (main protease andSpike/ACE2) profile of Montelukast through multiscale molecular modeling studies. Next,the investigators characterized its effect on both targets by different in vitroexperiments including the Fluorescent Resonance Energy Transfer (FRET)-based mainprotease enzyme inhibition assay, surface plasmon resonance (SPR) spectroscopy,pseudovirus neutralization on HEK293T / hACE2, and virus neutralization assay usingxCELLigence MP real time cell analyzer.

Fondazione IRCCS Policlinico San Matteo di Pavia

Early Use of Hyperimmune Plasma in COVID-19

Conditions: COVID19

The study assesses the efficacy of early administration of hyperimmune plasma in covid-19patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in theWHO scale

Genexine, Inc.

Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults

Conditions: SARS-CoV-2

The objective of our study is to evaluate safety, tolerability, and immunogenicity ofCOVID-19 preventive DNA vaccine in healthy volunteers.

AGIR à Dom

Evaluation of the Daily Intake of 0.5 L of Water Saturated With Molecular Hydrogen for 21 Days in COVID-19 Patients Treated in Ambulatory Care

Conditions: SARS-CoV-2, COVID19, AMBULATORY CARE

Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect inpreventing the runaway inflammatory reactions that lead to complications of Covid-19.This hypothesis is supported by numerous preclinical and theoretical arguments, as wellas by some Chinese clinical studies (the Chinese guidelines for the management ofCovid-19 recommend the inhalation of hydrogen), a recommendation whose interest has justbeen confirmed by a publication describing the very positive results of a clinical studyin China.Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect inpreventing the runaway inflammatory reactions that lead to complications of Covid-19.The ingestion of water saturated with molecular hydrogen has been the subject of severalclinical studies in other indications than Covid-19, and no side effects of thisingestion have been reported. A recent publication recommends initiating clinical trialsusing a hydrogen fortified beverage.

Reven Pharmaceuticals, Inc.

Tolerability and Efficacy of RJX in Patients With COVID-19

Conditions: COVID-19, Acute Respiratory Distress Syndrome, SARS-CoV-2, Hypoxemia

This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebocontrolled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacyof RJX in patients with COVID-19.

University Hospital, Rouen

Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

Conditions: Corona Virus Infection

At present, the offer of tests for the serological diagnosis of CoVID-19 (detection ofIgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of avery large number of rapid diagnostic unit tests, a few dedicated high throughputautomated systems or reagents on existing open systems. The offer will continue to expandin the coming months.In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HASreport of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific councilconcerning the potential use of these serological tests at the end of the COVID-19epidemic, the Virology laboratory wishes to validate the sensitivity and specificity ofthe tests it intends to use.

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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 (76)
  • Drug (64)
  • Biological (35)
  • Diagnostic Test (29)
  • Behavioral (10)
  • Device (8)
  • Procedure (6)
  • Combination Product (5)
  • Dietary Supplement (4)
  • Radiation (3)

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