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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.

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Aljazeera Hospital

Counseling of Pregnant Women During Corona

Conditions: Respiratory Tract Infections

Corona virus is known as covid 19 And is transmitted through droplet infection

National Institute of Respiratory Diseases, Mexico

Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)

Conditions: COVID-19, Severe Acute Respiratory Syndrome

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

Federico II University

Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy: The Italian Registry on Coronavirus in Pregnancy.

Conditions: Infection Viral

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.

National Cancer Institute, Naples

Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)

Conditions: COVID-19 Pneumonia

This study project includes a single-arm phase 2 study and a parallel cohort study, enrolling patients with COVID-19 pneumonia.

Azidus Brasil

NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia

Conditions: COVID-19 Pneumonia

This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.

VivaChek Laboratories, Inc.

Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in Early Detecting the Infection of COVID-19

Conditions: Coronavirus Infections

This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.

OncoImmune, Inc.

Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)

Conditions: Coronavirus Disease 2019 (COVID-19)

This study evaluates the efficacy and safety of efprezimod alfa in hospitalized adult participants who are diagnosed with coronavirus disease 2019 (COVID-19) and receiving oxygen support. The primary hypothesis of the study is clinical improvement in the experimental group versus the control group.

University of Bologna

Predictors of Respiratory Failure in SARS-Cov-2 Infection

Conditions: SARS-CoV-2 Pneumonia

The emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia. A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need ICU admission and/or those who may benefit from a prompt antiviral therapy

National Institute of Respiratory Diseases, Mexico

Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)

Conditions: COVID-19, Severe Acute Respiratory Syndrome

Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.

Uppsala University

Mechanisms for Organ Dysfunction in Covid-19

Conditions: COVID-19, Organ Dysfunction Syndrome Sepsis, Organ Dysfunction Syndrome, Multiple, Septic Shock, Acute Kidney Injury, Acute Respiratory Distress Syndrome

The study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.

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Status

  • Completed (1908)
  • Unknown status (1222)
  • Recruiting (404)
  • Terminated (328)
  • Active, not recruiting (275)
  • Withdrawn (216)
  • Not yet recruiting (60)
  • Suspended (30)
  • Enrolling by invitation (25)
  • No longer available (20)
  • Available (5)
  • Approved for marketing (3)

Intervention Type

  • Drug (1460)
  • Other (1239)
  • Biological (545)
  • Diagnostic Test (415)
  • Behavioral (261)
  • Device (242)
  • Dietary Supplement (104)
  • Procedure (104)
  • Combination Product (43)
  • Radiation (24)
  • Genetic (13)

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© Reagan-Udall Foundation for the FDA