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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 5 of 5

The Cleveland Clinic

Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation

Conditions: COVID, Corona Virus Infection

The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.

Providence Health & Services, Center for Outcomes Research and Education, Providence Cancer Center, Earle A. Chiles Research Institute

Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care

Conditions: COVID-19, Corona Virus Infection, SARS-CoV-2, 2019-nCoV, 2019 Novel Coronavirus

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

Bursa City Hospital

Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients?

Conditions: COVID

Blood vitamin D levels may be associated with COVID-19 disease severity, we aimed to find out whether blood 25-hydroxy vitamin D (25(OH)D) levels were correlated with COVID-19 disease severity or noy.

Fundacion Clinica Valle del Lili

Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus

Conditions: COVID19

A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.

Mayo Clinic

Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19

Conditions: Healthy, Health Care Worker Patient Transmission, Aging

The purpose of this research study is to look at high dose zinc versus multivitamin micronutrient supplementation to support immune health in the setting of the COVID-19 pandemic.

Status

  • Recruiting (77)
  • Not yet recruiting (35)
  • Active, not recruiting (10)
  • (-) Enrolling by invitation (5)

Intervention Type

  • Other (48)
  • Drug (28)
  • Behavioral (21)
  • Diagnostic Test (21)
  • Biological (15)
  • Device (10)
  • Procedure (5)
  • (-) Dietary Supplement (4)
  • Combination Product (3)
  • Genetic (1)
  • (-) Radiation (1)

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