- About
-
Projects
-
Column 1
- Advancing Regulatory Science
- Animal Health & Veterinary Medicine
- Expanded Access
- FDA Patient Listening Sessions
-
Column 2
- Food & Nutrition
- Improving Access to FDA Information
- Research
- Substance Use Disorders
-
Column 1
- News and Events
- Expanded Access eRequest
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 90 of 159National Research Agency, France
Conditions: COVID-19, SARS-CoV-2 Infection
On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency ofinternational concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003,SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations ofSARS-CoV-2 are dominated by respiratory symptoms, some patients have severecardiovascular damage. In addition, patients with underlying cardiovascular disease maybe at increased risk of death. Therefore, understanding the impairments caused bySARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmostimportance.Circulating endothelial cells (CECs) are generally considered markers of lesions and maybe non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection.Another marker of endothelial activation could be circulating extracellular vesicles.They could also be involved in the spread of the virus. Thus this project proposes tostudy different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose tofully study activation state of coagulation and endothelium on a plasma and cellular sidein patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will beincluded: without lung disease, with a more or less severe lung disease, i.e. havingevolved or not towards acute respiratory distress syndrome (ARDS). Extensive research ofbiomarkers will be compared to the detection of the virus in the respiratory tract aswell as in the blood. This work will contribute to a better description of diseasepathophysiology and should allow us to identify a patient profile in whom preventive orcurative anticoagulant therapy could be considered.
University Hospital, Basel, Switzerland
Conditions: Coronavirus Infectious Disease 2019 (COVID-19)
This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleicacid analysis platform from, but not limited to, saliva to help enable and supportcontact tracing in the canton of Baselland/ Switzerland. To achieve this, cruderibonucleotide acid (RNA) extraction from saliva is validated in combination withnext-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP)assays as well as point of care test (POCT) for rapid detection of viral antigens onpatients' samples.
Associazione Italiana Ematologia Oncologia Pediatrica
Conditions: Diagnosed or Relapsed/Refractory Sarcomas
Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are aheterogeneous group of tumors arising in connective tissues embryologically derived fromthe mesenchyme. For some of these tumors relapse and mortality rates are stillsignificantly high. Therefore, further studies are needed to better understandpathogenetic processes underlying sarcomas to offer new and more effective treatments.Next generation sequencing (NGS) has opened new frontiers for cancer research allowing toidentify somatic or constitutional mutations known or yet unknown with the aim to betterunderstand carcinogenesis. The establishment of the genomic profile of the tumor couldalso help clinicians to personalize patients treatment based on their genetic andmolecular alterations.
University of Sao Paulo
Conditions: COVID19, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection
The physical inactivity promoted by the patient's hospitalization, including thoseinfected with the coronavirus, can lead to an important health impairment, includingatrophy and loss of muscle function. Thus, a prospective study will be conducted toassess the effect of a home-based exercise training program on health outcomes andquality of life in COVID-19 survivors.
Cristina Avendaño Solá
Conditions: Acute Respiratory Distress Syndrome, COVID-19 Pneumonia
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy andsafety of MSC (mesenchymal stromal cells) intravenous administration in patients withCOVID-induced ARDS compared to a control arm.
Uniformed Services University of the Health Sciences
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
National Institutes of Health Clinical Center (CC)
Conditions: COVID-19
Background:People who are recovering from COVID-19 may continue to have problems that affect theirdaily life. For instance, they might feel overly tired. Researchers want to learn ifexercise can help people recover after COVID-19 infection.Objective:To study if participation in a rehabilitation exercise program can help people recoveringfrom COVID-19.Eligibility:Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causesCOVID-19), and are still having some symptoms.Design:Participants will have a medical history and physical exam. They will give blood andurine samples. They will have tests to measure heart and lung function. Their bloodvessels will be assessed.Participants will have a computed tomography scan of the body. They will have anultrasound of the muscles in their arms, legs, and chest.Participants will take a 6-minute walk test. They will take other balance and movementtests.Participants will walk on a treadmill while hooked up to a monitor. Then they will beinterviewed. It will be audio-recorded.Participants will complete surveys about their symptoms and daily activities.Participants will take a smell test. For this, they will identify different smells. Theywill also have memory, attention, and mental functioning tests.Participants will wear an activity monitor on their wrist 24 hours a day. They willexercise 3 times a week for 10 weeks by moving vigorously on a track or treadmill for 30minutes. They will attend education classes once a week for 10 weeks.Participants will be contacted by phone or email every 3 months for 1 year after theycomplete the exercise part of the study. They will wear an activity monitor for up to 2weeks.
Ankara University
Conditions: COVID 19
COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus namedas SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have adevastating effect on many organs, the respiratory tract is particularly affected. In thecourse of the disease, a wide clinical spectrum is observed, from flu-like illness tolung failure. Some of the patients who survived the disease continue to have problemssuch as shortness of breath, fatigue, decrease in walking distance, decrease inparticipation in daily life activities. These problems suggest that the effects onrespiratory and cardiac functions continue even after the disease ends. This study wasdesigned to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.
SK Bioscience Co., Ltd.
Conditions: COVID-19 (Healthy Volunteers)
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded,age-escalating study to assess the safety, reactogenicity and immunogenicity of a SKSARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with or withoutAS03 in healthy younger and older adults.
University of Malaga
Conditions: Long COVID-19 Syndrome
The COVID-19 can cause important sequels in the respiratory system by bilateral pneumoniaand frequently presents loss of strength, dyspnea, polyneuropathies and multi-organicaffectation. Long COVID-19 has been defined as the condition occurring in individualswith a history of probable or confirmed SARS-CoV-2 infection, with related symptomslasting at least 2 months and not explainable by an alternative diagnosis. The practiceof digital physiotherapy presents itself as a promising complementary treatment method tostandard physiotherapy, playing a key role in the recovery of function in subjects whohave passed the disease and who maintain some symptomatology over time. The aims of thisresearch are to explore the effect of a digital physiotherapy intervention on functionalrecovery in patients diagnosed with Long COVID-19 and to identify the level of adherenceto the treatment carried out. Physiotherapy interventions acquires a fundamental role inthe recovery of the functions and the quality of life. As secondary objectives, the aimis to identify the satisfaction and perception of patients with the intervention and thepresence of barriers to its implementation (throught a qualitative research), as well asto evaluate the cost-effectiveness from the perspective of the health system. Aquasi-experimental pre-post study assessed initially and at the end of the 4-weekintervention the functional capacity (1-min STS and SPPB) and the adherence (software).The hypothesis of this research is that the implementation of a TR program presentspositive results. If hypothesis is confirmed, that would be an opportunity to define newpolicies and interventions to address this disease and its consequences.