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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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Beijing 302 Hospital

Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer

Conditions: Patients With Cancers, COVID-19, Vaccine

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic sinceoutbreak in 2020. Patients with cancers may be at higher risk than those without cancerfor coronavirus disease 2019 (COVID-19). At present, limited data are available on thesafety and immunogenicity of COVID-19 vaccination for patients with cancer.

Jacobs University Bremen gGmbH

Coping With Covid-19: Loneliness, Self-Efficacy, Social Support, Depression & Anxiety in Patients in Medical Rehab.

Conditions: Loneliness, Depression, Anxiety, Self Efficacy, Social Support, COVID19, Psychology

Aim of the study is to investigate possible predictors and factors that may be associatedwith the development and maintenance of mental and physical health constrains includingdepression and anxiety symptomatology as well as loneliness in hospitalized post-COVIDpatients and non-COVID patients in Germany. Furthermore, it will be investigated whetherpsychological interventions have an effect on anxiety and depression symptomatology, onloneliness values, self-efficacy and perceived social support values. Specifically, theresearch aim is to examine the relationships between loneliness, self-efficacy, andsocial support and to address the question of what factors increase the risk of postcovid depression/anxiety, and to test the buffering effect of physical and socialactivities. For this purpose an experimental group comparison will be applied, in whichtwo interventions will be performed on post-COVID patients and non-COVID patients in theunit of Physical Medicine and Geriatrics in Medical Rehabilitation. (PhD Project byAnnika Roskoschinski, M.Sc., Psychology, Principal Investigator)

Weill Medical College of Cornell University

General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19

Conditions: Post-traumatic Stress Disorder, Moral Injury

It is expected that large numbers of healthcare workers will experience a broad range ofpsychological reactions and symptoms including anxiety, depression, moral distress, andtrauma symptoms that will cause both significant suffering as well as occupational andsocial impairment. The purpose of this study is to find interventions which are helpfulin treating psychological distress in healthcare workers caring for COVID-19 patients.There are two phases of the study. All participants will take part in Phase I, whichconsists of 4 sessions over a two-week period of either a narrative writing interventionor a medical music intervention. Participants will be randomly assigned to the narrativewriting intervention or medical music intervention.After Phase I, participants will be re-assessed. Healthcare workers who meet criteria forPTSD will be given the option to participate in Phase II of the study, in which they willbe offered a choice between one of two evidence-based treatments for PTSD: InterpersonalTherapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minutesessions scheduled twice weekly. Participants will be allowed to choose a preferredtreatment in Phase II. After Phase II participants will complete a final assessmentconcluding the study. All interventions will be offered using distance technology.

Esbjerg Hospital - University Hospital of Southern Denmark

Covid-19 Infection and New Onset Type 1 Diabetes

Conditions: COVID19, Type1diabetes

Although recognized as an autoimmune disease the etiology of type 1 diabetes remainsunknown. Virus infections has been suggested as a possible agent triggering theautoimmune reaction finally resulting in beta-cell destruction and fate of insulinsecretion. SARS Cov-2 virus enters the infected cells by binding to the ACE-2 receptor,which is abundant in many tissues including the pancreas. Accordingly, SARS Covid-19infection may trigger the development of type 1 diabetes either by an activation of theimmune system or directly via beta-cell infection and destruction.Our aim is to study the impact of the Covid-19 epidemic on the development of type 1diabetes. This will be done in two ways: a clinical study and an epidemiological followup. During the next two years, adult patients with newly diagnosed type 1 diabetes willbe asked to participate. Type 1 diabetes will be diagnosed by usual means and a mixedmeal tolerance test will be performed at time of diagnosis and after one year to evaluatebeta-cell function. People with type 1 diabetes and serologically documented previousSARS Covid-19 will be compared with people with no previous infection regarding beta-cellfunction and fate of insulin secretion. In addition, we will estimate the number of newdiagnosed type 1 diabetes patients compared to previous years.

University Hospital, Clermont-Ferrand

Influence of the COVId-19 Pandemic on STRESS and Eating Habits

Conditions: Nutrition

The Coronavirus has caused containment of more than a third of the world's population.Containment can drastically change lifestyle habits, including eating habits such as thenumber of meals, meal times or their composition. However, there is currently no data onthe influence of confinement on eating habits.

Associazione Italiana Ematologia Oncologia Pediatrica

Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas

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 Hospital, Clermont-Ferrand

Influence of the COVId-19 Pandemic on STRESS of Occupational Health Workers

Conditions: Occupational Health

Coronavirus has caused containment of more than half of the world's population and amajor and rapid reorganization of clinical and support services. The spread ofcoronavirus (COVID-19) has posed significant challenges for occupational health services.However, there is currently no data on the influence of this epidemic on the practice andfeelings of dental surgeons and associates

Chinese University of Hong Kong

Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19

Conditions: Lung Function, Exercise Capacity, Quality of Life, COVID19

(a) Objectives 1. To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years. 2. To assess the longevity of the serology response to SARS-CoV2. 3. To investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model 4. To investigate the SARS-CoV-2 specific cellular and humoral immunities as well as their determinant factors from community subjects who have received different types of COVID-19 vaccines. 5. To assess the third booster dose for subjects who have poor antibody response despite having received two doses of CoronaVac (Sinovac)

University of Bern

COVID-19 in People With Primary Ciliary Dyskinesia

Conditions: Primary Ciliary Dyskinesia

The COVID-PCD is a participatory research project that aims to study how COVID-19 affectspeople with primary ciliary dyskinesia (PCD). The study is advertised through patientsupport groups and participants register online and answer a baseline questionnaire withdetails on PCD diagnosis, habitual symptoms, and COVID-19 episodes occurring before studyentry. A short weekly follow-up questionnaire includes questions on incident SARS-CoV-2infections, current symptoms, social contact behaviour, and physical activity.Occasionally, participants receive extra questionnaires focused on special topics. Thestudy is hosted at the University of Bern and recruitment started on May 30th, 2020.

Società Italiana Talassemie ed Emoglobinopatie

Observational Study for Patients With Hemoglobinopathies and Rare Inherited Anemia and Covid 19

Conditions: Haemoglobinopathies

The COVID-19 pandemic is causing many deaths around the world, putting a strain on healthservices. Patients with pre-existing chronic conditions are most affected by theSARS-COV2 infection. Infectious complications are a common cause of mortality and one ofthe main causes of morbidity in all these diseases. The main objective of this project isthe assessment of patients with thalassemia, drepanocytosis, other haemoglobinopathiesand rares inherited anemias suffering from SARS-COV-2 to: 1. Obtain clinical and epidemiological data that can provide information on a possible increased vulnerability of these patients to SARS-COV-2 infection; 2. Sharing therapeutic approaches considering the lack of information about the treatment.

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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 (48)
  • Drug (19)
  • Biological (14)
  • Behavioral (8)
  • Diagnostic Test (8)
  • Device (4)
  • Dietary Supplement (2)
  • Radiation (2)
  • Genetic (1)

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