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 120 of 368Baqiyatallah Medical Sciences University
180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in close contact with patients, will enter the study. Participants will be divided into two intervention groups and one control group. The control group will use the full protective equipment assigned to the treatment staff. In addition to protective equipment, the first intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second intervention team, while observing and using the complete protective equipment, will place a thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours. At the beginning of the treatment, qualified people will participate in the study while recording demographic and clinical information, PCR test will be performed, and if they have negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of the disease occur in each of the participants, the test will be taken again. If the test is positive, the person will withdraw from the study, and the patient's information will be recorded. Finally, the people present in the study will be tested for PCR, and the results of the disease and the side effects of the drugs will be compared.
KGK Science Inc.
Corona virus disease 2019 (COVID-19) is caused by SARS-CoV-2, a plus-sense single-stranded RNA virus. After an incubation period, which typically lasts for 5-6 days, COVID-19 patients present with a mild illness that lasts for a few days. Common symptoms are reminiscent of the flu, and include fever, dry cough and dyspnea. A large percentage of patients resolve the infection whereas others progress onto adult respiratory distress syndrome (ARDS) which impedes gas exchange between the alveolar space and the bloodstream and creates the need for assisted respiration. The objective of this study is to investigate the safety and efficacy of CARDIO supplementation in the recovery of those with COVID-19 infection following the guidance from public health by reducing the need for mechanical respiratory support, alleviating respiratory symptoms and reducing mortality.
Cambridge University Hospitals NHS Foundation Trust
This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19. These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly sample the primary transmission route for the virus. They can be used independently and shipped for analysis for the presence of nCOVID-19 using established existing assays available in any reference lab. The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face mask vs. available diagnostic procedures in standard care and will also asses the feasibility of patient use of the equipment. Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected. Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to obtain to address the primary study hypothesis. Due to the pre-test probability of patients being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a combination of imaging, viral diagnostics and clinical assessment will be used as the reference standard. When this number hits 100 the study will be discontinued. In total no more than 500 subjects shall be sampled in this trial.
Centre Hospitalier Intercommunal Creteil
Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic
Hanane EL KENZ
When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate. The pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an "secreting" individual, the antigens of the "ABO" system of the infected individual will be present on the surface of the viruses formed in his/her lungs. It was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "ABO" system carried by the virus. A patient of group "O" would thus defend himself much better against a virus carrying antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups. In order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of patients and "ABO" of nursing staff in health care units, if operational and human conditions allow.
University of Wisconsin, Madison
The purpose of this research study is to evaluate and improve a rapid COVID-19 test. The test is designed to identify people who are most contagious and likely to spread the virus to others. This test will be performed at various locations in the Madison area using a mobile laboratory or standard lab space for processing. Saliva samples can be collected and processed at these locations or participants can self-collect at home and drop their samples off at designated locations for same day processing. Results of potential findings of clinical significance will be communicated to the participants by a physician with appropriate expertise on the study team. Individuals with a potential finding of clinical significance will be encouraged to self-isolate and obtain a diagnostic test at their earliest convenience. No results will be given if the test is negative. If the participant consents, advanced molecular testing such as PCR or viral sequencing can be done and results can be shared via online databases, presentations and publications along with the date, site and county of collection to help facilitate tracking the spread of the virus.
University of California, Los Angeles
The purpose of this research is to conduct a cross-sectional survey to investigate how people's lifestyle decisions and social distancing choices are affected by the medical information they receive. The hypothesis is that a positive COVID-19 test result will lead to study participants having the greatest self-isolation intentions compared to those who are only clinically diagnosed for COVID-19 without a confirmatory diagnostic test result or those who receive a negative COVID-19 test result.
Rutgers, The State University of New Jersey
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).
Stony Brook University
The goal of this study is to test whether an online, self-administered SSI designed to strengthen perceived control over anxiety in the context of the COVID-19 pandemic (Contain COVID Anxiety) increases perceived control over anxiety more than a placebo, hand-washing-plan SSI (Remain COVID Free) in a weighted-probability sample of the United States (N = 500).
Karolinska Institutet
This research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week 0). Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. their smartphone for part of the intervention in the study.