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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 60 of 530

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

Mercy Research

Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19

Conditions: COVID19, Pregnancy Related, Maternal Complication of Pregnancy, Coronavirus, Neonatal Infection, Prenatal Stress, Preterm Birth

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated withan increased risk preterm birth, cesarean section, and maternal critical care. This studywill examine the factors that impede testing for SARS-CoV-2 (the causative virus amongpregnant women), help determine optimal testing strategies by evaluating the necessity oftesting for asymptomatic disease in pregnancy, inform prenatal care plans by assessingthe full impact of infection, and contribute to a provider's ability to counsel women andcreate prenatal care plans if they are pregnant or considering pregnancy.

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.

University Medical Center Groningen

Vaccination Against COVID-19 in Cancer

Conditions: Cancer

This study will collect information on immune response and adverse events aftervaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort.Understanding the ability or disability to mount a protective immune response aftervaccination will help to counsel patients during the pandemic and support decisions onwhom to vaccinate and to identify patients who require other measures to protect themfrom COVID-19.

Boston Children's Hospital

HEALthy Brain and Child Development Study - COVID-19 Supplement

Conditions: Child Development, Prenatal Infection, Prenatal Stress, COVID19

The purpose of this study is to advance the scientific understanding of how a prenatalCOVID-19 infection and associated psychological distress influences infantneurodevelopment. This project will aim to shed light on how families and childdevelopment are impacted by the current COVID-19 pandemic and will work to better supportthese families and children as they grow.

Nottingham University Hospitals NHS Trust

NoRCoRP Assessment Clinic

Conditions: COVID19

The main overarching aim of this study is to build a research clinic, as part of theNoRCoRP platform covering Nottingham and Nottinghamshire to facilitate learning andresearch in the whole population of patients who have had COVID-19.

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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 (159)
  • Drug (134)
  • Biological (75)
  • Diagnostic Test (51)
  • Behavioral (24)
  • Device (16)
  • Procedure (11)
  • Dietary Supplement (8)
  • Radiation (7)
  • Combination Product (5)
  • Genetic (1)

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