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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 160 of 254

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.

InCor Heart Institute

Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19)

Conditions: Respiratory Distress Syndrome, Mechanical Ventilation, SARS (Severe Acute Respiratory Syndrome)

This is a prospective, randomized, single-center, open-label controlled trial, designedto compare the efficacy of two ventilation strategies (Low Tidal Volume and positiveend-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS)Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versusLow Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducingdaily lung injury score in patients with acute respiratory distress syndrome caused byCOVID-19. The two strategies incorporate different prioritizations of clinical variables.The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requirestolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stressprotection, avoiding alveolar overdistension and collapse.

Surgical Systems Research Group

Western Kenya Integrated COVID-19 Response

Conditions: COVID19

To respond to the COVID-19 pandemic, investigators will be deploying community healthworkers, equipped with mobile technology, and accompanied by youth to visit householdsdoor to door to screen for symptoms of COVID-19, isolate, test, and manage suspectedcases of COVID-19. The community health workers and youth will educate households aboutpreventive measures including frequent handwashing and home management of mild cases.Simultaneously, investigators will work with nurses, doctors, and clinical officers, totest and treat more severe cases of COVID-19 in health facilities. Our goals are: tovisit every household in Siaya county covering a population of close to 1 million, and totrain and support health workers working in 32 health facilities with oxygen capacity inSiaya to reduce the morbidity and mortality related to COVID19 and other conditions.

Uniformed Services University of the Health Sciences

Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study

Conditions: COVID19

This is a multi-center, observational study that will enroll 1) patients with severeCOVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2)patients (medical record data) that have been previously treated with the Seraph® 100after the date of the EUA approval (17 April 2020), but before the date that the study isapproved at the study site, and 3) a convenience sample of patients (medical record data)in a historical control group who were admitted to the ICU at participating sites withsevere COVID-19 infection, meeting the EUA treatment criteria, but not treated withSeraph® 100 up to the time the PURIFY-OBS protocol is approved at the site

University Hospital of Ferrara

Recovery Profiles in Patients With SARS-CoV-2 Outcomes Undergoing Rehabilitation

Conditions: Covid19_rehabilitation

COVID19 patients survivors, after discharge from hospital show reduced lung function andreduced ability to exercise. Furthermore, mental health problems including stress,anxiety and depression and a low quality of life were observed. The prospectiveobservational study involves COVID19 patients who have needed rehabilitation at theUniversity Hospital of Ferrara. Patients receive comprehensive rehabilitation based ontheir specific needs in both acute and subacute rehabilitation. At the end of hospitalrehabilitation, patients are offered a program to be carried out at home for bothphysical and psychological problems. A range of demographic and clinical data will becollected. Patients will also undergo a battery of functional, cognitive andpsychological tests at 12, 26 and 52 weeks from the infection onset. Moreover, a specificassessement (both clinical and instrumental) on the pain symptom experienced, wherepresent, will be done.

AB Science

Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

Conditions: SARS-CoV 2, COVID-19, Coronavirus Disease 2019

Study objective is to evaluate the efficacy of the combination of masitinib andisoquercetin in adult hospitalized patients with moderate and severe COVID-19.

Hôpital Européen Marseille

Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital

Conditions: COVID19

The purpose of the study is to Assess of Long-term impact post COVID for patients andhealth care professionals.The patients and medical staff will be followed for 2 years inorder to provide clinical and paraclinical data not yet published in the literature.

The Hospital for Sick Children

Convalescent Plasma for COVID-19 Research Donor Study

Conditions: COVID19

Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, naturalhistory study of plasma donors recovered from COVID-19. CONCOR-Donor study will addressimmune response, duration of protective immunity, and clinical factors and host geneticscontributing to the variability of immune response. We will also study long-term outcomesfrom COVID-19 infection. Results from the study will help define therapeutic strategiesfor COVID-19.

Public Health Foundation of India

WORLD HEART FEDERATION (WHF) COVID-19 and Cardiovascular Disease Survey

Conditions: COVID-19, Cardiovascular Diseases

A global study for a better understanding of the cardiovascular conditions that increasethe risk of developing severe COVID-19, and a better characterization of cardiovascularcomplications in hospitalized patients with COVID-19.

University of California, Los Angeles

Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions

Conditions: Corona Virus Infection

This study will provide access to investigational anti-SARS-CoV-2 human convalescentplasma for pediatric patients with underlying medical conditions (cardiovascular disease,lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have hada high-risk exposure. Study participants will be transfused once with compatibleconvalescent plasma obtained from an individual who has recovered from documentedinfection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

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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