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.
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Displaying 100 of 143Assistance Publique - Hôpitaux de Paris
The purpose of the study is to describe disability following hospitalization in people ofworking-age surviving COVID-19.
Cardresearch
The COVID-19 pandemic has been characterized by high morbidity and mortality, especiallyin certain subgroups of patients. To date, no treatment has been shown to be effective inpatients with early-onset disease and mild symptoms. Experimental studies havedemonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonideand Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggesteda reduced complications in patients with COVID-19 disease.
Emilia Falcone, MD
Sample Size: n=570Accrual Ceiling: n=627Study Population: Patients age 18 to 100 yearsThe study duration includes 51 months to recruit patients and 24 months of totalfollow-up time counted from the first day of COVID-19 symptoms or date of confirmedCOVID-19 diagnosis.Study Design: This is a prospective, observational cohort study to evaluate the short-and long-term end-organ complications of COVID-19 and to establish a COVID-19 biobank.Participant Cohorts: 1. Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) 2. Individuals who had previous moderate or severe COVID-19 (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation) 3. Individuals who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis 4. Individuals who have not had COVID-19 (i.e. individuals who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)
Charite University, Berlin, Germany
NAPKON-HAP is the deep phenotyping platform of the National Pandemic Cohort Network(NAPKON) in Germany. NAPKON is a data and biospecimen collection of patients withCOVID-19 and is part of the University Medicine Network (NUM) in Germany. The primaryobjective of the study is to provide a comprehensive collection of data and biosamplesfor researchers from national consortia and for participation in international researchcollaborations for studying COVID-19 and future pandemics.Data is collected from patients with COVID-19 three times per week during theirhospitalization and at follow-up visits after hospital discharge 3, 6, 12, 24, and 36months after symptom onset. Data include epidemiological and demographic parameters,medical history and potential risk factors, documentation of routine medical procedures,and clinical course, including different patterns of organ involvement, quality of care,morbidity, and quality of life. Moreover, extensive serial high-quality bio samplingconsisting of various sample types is performed to allow deep molecular, immunological,and virological phenotyping.Patients not requiring Intensive Care Unit (ICU)/ Intermediate Care (IMC) treatment willreceive 7 and patients requiring ICU/IMC treatment will receive 16 full-phenotypingvisits including sampling for biobanking. During hospitalisation the planned bloodsampling rate in total is 35 ml at each visit. The total amounts and/or sampling datesmay differ according to the ethics committee's regulations for different study centers.At follow-up visits, the clinical assessment includes an update of the medical historyand recent medical events from which additional clinical data is collected (i.e.outpatient CT-scans, echocardiography, external laboratory data). Clinical symptoms arerecorded and a physical examination will be performed. Vital signs are recorded androutine blood testing and biosampling is continued. Quality of life is measured withpatient-reported outcome questionnaires.Follow-up visits at months 3 and 12 are "deep phenotyping" visits with a comprehensiveand detailed set of examinations. In the following visits at months 24 and 36, onlyexaminations with pathologic results from the last deep phenotyping visit at month 12will be performed.A shorter follow-up visit to record quality of life, recent medical events and with areduced number of examinations focusing on cardiorespiratory performance will take placeat month 6.In case of relevant medical events, new medical information or changes in theparticipant´s health status, an unscheduled visit can take place anytime within theentire study period.Data collection during follow up includes standardized quality of life assessmentincluding PROMIS® (Patient-Reported Outcomes Measurement Information System). Thepulmonary characterization will include body plethysmography, diffusion capacity,respiratory muscles strength measurement, spiroergometry, capillary blood gas analysisand lung imaging studies (low-dose Computed Tomography (CT), Magnetic Resonance Imaging(MRI) of the lung). Cardiological phenotyping includes echocardiography,electrocardiogram (ECG), 24h-ECG, 24h-blood pressure monitoring, stress cardiac MRI andpulse wave analysis. Neurocognitive testing includes brain MRI, electroencephalogram(EEG), somatosensory testing, refractometry (Visit 3 and 12 months), physical activitytest, neurocognitive tests, somatosensory phenotyping, taste- and smell-test.Endocrinological phenotyping will incorporate Advanced Glycation Endproducts (AGE)reader, continuous glucose monitoring for 14 days, Air Displacement Plethysmography (ADP)or bioelectrical impedance analysis (BIA).
Ankara University
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.
ClinAmygate
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)
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.
Medialis Ltd.
Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)
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.
University of Alabama at Birmingham
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.
Tourcoing Hospital
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.