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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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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The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry(C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinatedduring pregnancy with a COVID-19 vaccine.Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneousabortion, antenatal bleeding, gestational diabetes, gestational hypertension,intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture,placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes(major congenital malformations, low birth weight, neonatal death, neonatalencephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth,respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19),and infant outcomes (developmental milestones [motor, cognitive, language,social-emotional, and mental health skills], height, weight, failure to thrive, medicalconditions during the first 12 months of life, COVID-19) among pregnant women exposed tosingle (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 daysprior to the first day of the last menstrual period to end of pregnancy and theiroffspring relative to a matched reference group who received no COVID-19 vaccines duringpregnancy.
Haukeland University Hospital
The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by nopopulation-based immunity to the severe acute respiratory disease coronavirus 2(SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigatethe pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europethrough conditional marketing authorisation granted by the European Medicines Agency andfurther vaccine will be licensed. These vaccines have shown good vaccine efficacy inphase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccinationwith the primary aim of comparing the immune responses after COVID-19 vaccination andnatural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health careworkers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees.Demographic, clinical data and repeated blood samples will be collected to evaluate thecomplications and kinetics, duration and breadth of the immune responses comparingnatural infection to vaccination.
University of California, San Francisco
There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in theoutpatient setting on prevalent and incident renal injury, as this data is currentlyunavailable. To capture the diversity of race/ethnic risk and COVID19 related municipalshelter-in-place guidance, the investigators will enroll COVID19-negative andCOVID19-positive samples balanced by race/ethnicity from 3 different states, California,Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to thestudy team at 2, 6, and 12 months after their date of PCR test, with no requirement forthese individuals to leave their homes to participate.
Nanowear Inc.
The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility,observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10and a maximum of 100 subjects in a potential for a multi-site in order to collect dataand analyze physiological and biometric trends due to Covid-19.
Assistance 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.