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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.

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ClinAmygate

Patients Reactions Towards Their Diagnosis as Having COVID-19

Conditions: COVID19

Patients reactions towards their diagnosis as having COVID-19. The effect of patients'reaction toward their prospect management. How this can make many hazards. Also, obstacleand barrier to better management.

National Institute of Allergy and Infectious Diseases (NIAID)

Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence

Conditions: Covid-19 Infection

Background:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem.COVID-19 causes a wide range of symptoms. These symptoms range from mild breathingproblems to life-threatening problems or death. Some people have no symptoms. This studyaims to learn how acute and late immune responses to COVID-19 lead to different outcomes.The immune system is the body s defense against germs, including viruses, that invade thebody.Objective:To characterize the immune responses during and after SARS-CoV-2 infection and determineif there is any relationship to clinical course and outcome.Eligibility:People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are notinfected despite heavy exposure, and relatives of enrolled participants.Design:This is a sample collection protocol to receive send-in biological specimens forexploratory studies, including gene testing. Participants will not be seen at the NIH forstudy visits.Study staff will talk with participants health care providers to screen them for thestudy. Participants enrolled into the protocol will send samples and clinical informationat least once and more often if the participant has COVID-19. All participants willprovide blood samples and possibly stool. We may also ask for left over specimens fromany medical procedures completed as part of medical care. The study staff will alsorequest participants health care providers to complete a survey to collect demographicand medical data. Some of this information may need to be provided directly by theparticipant.Pregnant individuals are invited to participate and may be asked to give cord bloodsamples after delivery. Study findings that affect participants health may be shared withtheir health care provider. Depending on findings, participants may be contacted to takepart in other NIH studies.

National Institute on Aging (NIA)

A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults

Conditions: COVID19

The proposed trial will obtain preliminary data on the feasibility of studying RTB101 ascompared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years toinform the design of a subsequent pivotal trial.

Medialis Ltd.

Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)

Conditions: COVID19

Coronavirus Disease 2019 (COVID-19) is a newly emerged disease, caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 pandemic is having a largeimpact on the mental and physical health of patients, yet data on the quality of life ofpost-COVID-19 patients is lacking. There are currently no post-COVID-19 specific measuresfor quality of life, particularly none which include the views of post-COVID-19 patientsthemselves. This observational study will recruit participants to contribute theirpreferences to the creation of a post-COVID-19 specific patient-reported measure onpost-COVID-19 quality of life. Participants will be split into three groups: those whowere not hospitalised; those who were hospitalised but not in intensive care units; andthose who were hospitalised and in intensive care units. The creation of this measurewill form phase 1 of the study, with 30-60 participants (10-20 in each group above)recruited to complete online surveys to find out their preferences of areas of life toinclude in such a measure. This will involve 3 online surveys, 1) to ask which areas oflife they feel are impacted and how; 2) to find consensus about the areas to be included;3) to weight the relevance of these areas in relation to each other. In phase 2recruitment will open to additional participants and all participants will be asked tocomplete the finalised post-COVID-19 quality of life measure once a month for 12 months,aiming for a minimum of 100 participants at this stage. All participants will also beasked to complete a demographic questionnaire to inform the analysis of the data.

London Health Sciences Centre

Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection

Conditions: COVID19

This is a longitudinal study of the long-term impact of COVID-19 on the lungs.Participants will be followed over a period of up to 4 years and impacts of COVID-19 onthe lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarizedxenon-129, pulmonary function tests, exercise capacity, computed tomography imaging andquestionnaires.

University of Alabama at Birmingham

VEGF and SFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease

Conditions: COVID-19 Disease

To assess blood levels of vasoactive mediators that may regulate pulmonary endothelialpermeability and contribute to multi-organ injury in patients with COVID-19 disease andto correlate the levels of these mediators with disease outcomes such as ICU admission,length of ventilatory support, respiratory failure, kidney failure, heart failure, anddeath.

Assistance Publique - Hôpitaux de Paris

French Cohort of COVID-19 Patients With Post-intensive Care Syndrome

Conditions: COVID19

The purpose of this study is to describe post-intensive care syndrome (PICS) of patientssurviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recoveryprocess from hospital to home return

Tourcoing Hospital

Late Clinical Events Associated With COVID-19 Infection

Conditions: COVID19

Several publications document the occurrence of symptoms that persist or occur late.The identification of the observed clinical manifestations and their clinical andparaclinical description are essential to better understand the natural evolution ofCOVID-19, to clarify the pathophysiological mechanism of these possible latemanifestations, and to identify potential management options for patients.Since this type of event is infrequent, a large-scale national multicenter cohort studyfocusing on symptomatic patients is needed.

GeneOne Life Science, Inc.

GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)

Conditions: Pneumonitis, SARS-CoV Infection

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 inthe prevention of severe pneumonitis caused by SARS-CoV-2 infection

Charite University, Berlin, Germany

Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19

Conditions: COVID-19 Pneumonia

The aim of the joint project PROVID is to contribute to better outcome prediction forCOVID-19 patients, to better clinical management, and to the development of newtherapies. To this end, the investigators will collect detailed data on the course ofCOVID-19 patients and deeply characterize them at the molecular level. The investigatorsalso aim to identify compounds with the potential to improve outcome.The PROVID-PROGRESS study is being carried out as a prospective, longitudinal,multicenter observational study (case cohort study) with material asservation forgenomic, transcriptomic and proteomic analyzes on adult patients with 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