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 230 of 364Oslo University Hospital
Neurologic, neuropsychological and neuropsychiatric symptoms, signs and diagnoses are increasingly being reported in COVID-19 patients. However, the extent and implications of such "NeuroCOVID" involvement, as well as blood and MRI biomarkers for neurological and psychiatric COVID-19-affection and treatments, warrants further studies. The investigator will perform a national study with clinical and biomarker assessments of NeuroCOVID in approximately 150 Norwegian patients, recruited from ongoing COVID-studies in Norway as well as from neurological departments in Norway. The investigator will define the burden of neurological, psychological and psychiatric complications of COVID-19 disease and identify clinical characteristics and biomarkers for both short- and long-term neurological treatment and rehabilitation. Blood samples for biomarker analyses, brain MRI, clinical neurological, neurophysiological and neuropsychological assessments will be performed at 6 and 12 moths after acute disease,
Bayer
Niclosamide (2000 mg QD) and Camostate (600 mg QID) are expected to be safe and well-tolerated as a combination therapy and to show clinically beneficial for COVID-19 patients.
Colgate Palmolive
Subjects (125) will be randomized to one of five mouthrinses and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash. Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva will be used for RT-PCR detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex). Subjects will complete a short survey on the taste and experience of using the mouthwash. Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products. In the seven-day period between study visit one and study visit two, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are asked to carry out their typical oral hygiene regimen with the products they typically use. All subjects keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures. Subjects complete study visit two one week after the baseline visit during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse) will occur and blood samples collected. each subject will undergo a periodontal exam.
The Cleveland Clinic
This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in patients with active mild to moderate COVID-19 infection. The hypothesis is that COVID+ patients with uncomplicated acute appendicitis or acute cholecystitis amendable to a laparoscopic procedure can have safe operative outcomes compared to those managed non-operatively.
University of Campania "Luigi Vanvitelli"
In order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the Sars-CoV-2 infection. The first goal of this study will be to detect the cellular-mediated immune response in patients affected by COVID-19 (with or without vaccination) and healthy subjects who undergone vaccination program. The second goal of this study will be to identify the genetic and epigenetic biomarkers that influence individual immunological response and clinical evolution to the severe manifestations of the COVID-19.
Meyer Children's Hospital IRCCS
The new coronavirus (SARS-CoV-2) causing COVID-19 is an RNA virus coated with a capsid and a peri-capsid crossed by glycoprotein structures. The external proteic structure, which attacks human cells, is a potential target to therapeutic interventions against virus replication in airways. Since high temperature can cause irreversible denaturation of proteins and loss of SARS CoV and SARS CoV-2 infectivity was obtained after heating at 56 ◦C for 15 and 30 min in liquid environments respectively, we designed a protocol aimed at damaging SARS-CoV-2 capsid through steam inhalation cycles. Although the ominous consequences of COVID 19 infections has directed medical attention toward solidly established medical approaches, the European Pharmacopoeia VI edition also quotes steam inhalations as a procedure to treat of respiratory diseases. Based on these suggestions we established a quasi-randomized clinical trial enrolling 200 asymptomatic or paucisymptomatic patients in whom rhino-pharyngeal-swab revealed a SARS-CoV-2 infection. The study protocol consisted of exposure of airway mucosae to humidified steam (pH 8 per NaHCO3 and hypertonic 15 g/L NaCl) through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days. The objective of the study is to reduce the viral shedding using steam inhalations.
M.D. Anderson Cancer Center
This early phase I trial identifies the feasibility, possible benefits and/or side effects of administering SARS-CoV-2 specific cytotoxic T lymphocytes (CTLs) in treating cancer patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the virus responsible for coronavirus disease 2019 (COVID-19). SARS-CoV-2 Specific CTLs are a type of immune cells that are made from donated blood cells grown in the laboratory and are designed to kill cells infected with SARS-CoV-2 virus. Giving CTLs may help control the COVID-19 in cancer patients.
Baylor College of Medicine
Background: Conventional face-to-face in-hospital mobility program (MP) is challenging for COVID-19 patients because of its associated risk of infection to hospital staff, staffing shortages as well as indirect risk of exposure to other hospitalized patients. Exergames are digital or web-based games that use body movement to promote physical activity and generally involve strength, balance, and flexibility exercises. The tele-exergame MP, developed by the team, uses a remotely supervised and game-based approach, which helps to increase patient motivation and engagement in a cognitively demanding exercise program. Objectives: To demonstrate the feasibility, acceptability, and effectiveness of the Tele-Exergame mobility program in COVID-19 or PUI (persons under investigation), during hospitalization and examine post-hospitalization outcomes. Research Design: Prospective randomized
Heinrich-Heine University, Duesseldorf
This is a prospective, multi-center, observational study that will enroll patients receiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidney transplantation who will be vaccinated against COVID-19.
East Carolina University
The COVID-19 pandemic has highlighted deleterious US health inequities. Specifically, African Americans, Latinos, and Native Americans have and continue to shoulder a greater burden of COVID-19 infections and deaths in the US. In addition to existing racial and ethnic disparities are rural health and regional disparities. Given the disproportionate impact of disease in US communities of color and also in rural and southern regions of the US, there is no doubt that these at-risk subgroups will continue to experience higher rates of coronavirus-related mortality as well as other long-term health outcomes as compared to other US populations. It is unknown how healthcare providers and other key at-risk subgroups within the US will receive COVID-19 vaccines. For success in immunizations, the US will need to reach their most at-risk and vulnerable populations. In addition to at-risk populations, a successful immunization strategy will involve engaging providers to support clear, consistent, and strong vaccine recommendation. It is critical to build vaccine trust, confidence, and overall acceptance of COVID-19 vaccines among healthcare providers and key at-risk subgroups, especially given the accelerated production timeline of these vaccines. Likewise, tailored vaccine messaging for key subgroups is vital in achieving vaccine confidence and trust. The proposed study will explore perceptions, confidence, trust, and uptake of potential COVID-19 vaccines among healthcare providers (nurses and doctors) and key at-risk population subgroups (minority populations living in the rural south) and will develop and test vaccine messaging that boosts vaccine confidence and trust among these key at-risk subgroups.