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 360 of 590Golden Jubilee National Hospital
Patients are part of a family network. When any person in a family becomes critically unwell and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all members of that family. COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what effect these restrictions will have on patients' recovery, nor do we understand the impact it may have on their relatives or staff caring for them. This study will look at the implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact of these restrictions on them, their relatives and staff. This study will be carried out within a single specialised intensive care unit in Scotland using mixed methods. The first arm of this study will use retrospective data that is routinely collected in normal clinical practice. The investigators will compare patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions. The aim is to establish if the restrictions on visiting has an impact on the duration of delirium. Delirium is an acute mental confusion and is associated with longer hospital stays and worse outcomes in this patient group. The second arm of this study involves semi-structured interviews with patients, relatives and staff that will allow deeper exploration of the issues around current visiting policy. The interviews will last approximately 1 hour and will address these issues. They will then be transcribed word for word and analysed using grounded theory, meaning the theories will develop from the data as it is analysed.
Agencia Costarricense de Investigaciones Biomedicas
Describe the immune response of patients affected by SARS-CoV-2, including an assessment of the types of antibodies elicited by the infection, specifc antibody titers for the different isotypes, evolution of the antibody response over time, protective efficacy and immune correlates of protection. investigate genetic determinants of Covid-19 and of the imune response to this condition. Finally, the study will investigate secondary infection rate and its determinants among household contacts of Covid-19 patients.
Instituto Oncológico Dr Rosell
Methodology: This is a controlled, randomized, multicenter open-label Phase Ib clinical exploratory trial in patients with fibrosing interstitial lung disease secondary to SARS-CoV-2 infection. Patients who give informed consent will be screened for enrolment in the study. Patients that meet the eligibility criteria will be enrolled and randomly allocated in the control arm (best standard of care) or the experimental arm (best standard of care plus IN01 vaccination). The patients enrolled in the control arm of the study will receive standard of care. The primary endpoint is safety, measured by the Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria. Biochemical and blood count alterations will be also monitored. Safety will be defined based on the frequency and severity of adverse events (AEs) throughout the patient's participation in the study comparing between control and experimental arms. Efficacy will be measured as function of the annual rate of decline in the Forced Vital Capacity (FVC) at 1 year after patient inclusion in the study and the blood oxygen saturation levels at days 1, 14 (w2), d 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52. High-resolution Computed Tomography (CT) scans will be taken at at baseline and weeks, 12, 24, and 52 to evaluate the resolution of the fibrosing interstitial lung disease. A translational substudy will be included. Objectives: Primary Objective ● To evaluate the safety and tolerability of IN01 vaccine in diagnosed ex-COVID-19 patients that develop fibrotic lung syndrome after infection. Secondary Objectives - To evaluate the effect of IN01 vaccine on Oxygen saturation, pulmonary function, quality of life and fibrosing status in ex-COVID-19 patients that developed fibrosing lung disease after infection. - To assess biomarkers and molecular markers related to the IN01 vaccine mechanism of action.
Centre Médical de Kinshasa (CMK)
Investigators study meet the World Health Organization definition of a clinical trial because it is a prospective study in which participants will be assigned to intervention groups to investigate the effects on health outcomes. Investigators highlighted clearly the real problem that indigeneous patients are facing now in the Democratic Republic of the Congo: Poverty meaning the lack of money to buy goods and drugs. From the news report, investigators learned that "In the Democratic Republic of the Congo, indigenous communities in Kananga, Tshikapa and in the Kasai region are increasing their consumption of "Vernonia amygdalina," a traditional plant believed to cure several diseases, including alleviating COVID-19." Based on an unpublished work, quite a few extract molecules of Vernonia amygdalina are excellent antiviral candidates which are the family members of Remdesivir in terms of their antiviral mechanisms. Furthermore, the antiviral capabilities of these molecules are significantly stronger than or at least equivalent to Remdesivir. The target zones of these molecules in the human body cover a set of important organs and tissues. For example, Vernolide (C19H22O7) is able to reside firmly at bronchi, the upper respiratory tract, and blood vessels. From the news report, investigators learned also that Herbs used in Tanzania include lemon, ginger, neem tree leaves, mango tree leaves, orange tree leaves. These traditional medicines contain, more or less, antiviral molecules whose capacities range from good to outstanding levels. Those herbs have been used worldwide to fight COVID-19. In conclusion traditional medicines have been playing important roles not only in Africa but also in Asia, in South America, etc. Herbs prove themselves with effective efficacies in many therapeutic practices. So maybe after careful considerations, the World Health Organization may support the use of herbs for poor patients who cannot afford modern drugs and used traditional medicines after a positive COVID-19 test in the Democratic Republic of the Congo. Investigators are talking about a randomisation's nuance process to follow participants who decide by themselves if diagnosed positive to COVID-19 to begin to take herbs not waiting for a physician prescription.
University of Oxford
A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.
Trate - Tratamentos Especializados
Brazil has the Latin America's largest coronavirus outbreak, numbers second only to the United States in the western hemisphere. The first COVID-19 confirmed case in Brazil was on February of 2020. A 61yrs old man tested positive after returning from a trip to Italy. Few other very first cases were also imported from Europe by returning travelers. The first locally transmitted case was registered on March of 2020, when a total of 8 cases have already been confirmed. At the time the WHO declares the outbreak as a pandemic (March 11) Brazil had 52 confirmed cases being 6 of those locally transmitted. Healthcare professionals are now more important than ever. Given the intrinsic nature of the hands-on treatment of the Chiropractic profession, it is extremely important to understand what strategies chiropractors have put in place to address patient care, safety, and self report COVID contamination of those professionals.
University Hospital, Akershus
A multicenter prospective cohort study performed at 6 major teaching hospitals in Southern Norway to study patient reported outcomes, lung function and pulmonary CT in patients at 3 and 12 months after hospitalization for coronavirus disease 2019 (COVID-19).
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
University Health Network, Toronto
The COVID virus is acquired through droplet and micro droplet transmission. Although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these procedures are quite complex and involve multiple steps in stressful situations. Further the use of a trained safety officer to ensure adherence is not always feasible due to the ever growing demand of healthcare providers. Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to develop a voice enabled virtual assistant to guide healthcare professionals through the exact steps of clinical procedures including the donning and doffing of PPE, intubation and extubation procedures. Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of the study to evaluate the utility and functionality of this VA device. A total of 40 healthcare professionals will be recruited to participate in phase 2 of the study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory assistants and operating room nurses will be randomized to receive instructional guidance by the VA on one test occasion and a human coach on another occasion. During this phase of the study, the effectiveness of this VA prototype will be compared with a trained human safety officer / coach in its ability to provide instructional guidance for 4 safety and clinical procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3) intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).
General and Maternity Hospital of Athens Elena Venizelou
The aim of this study is to assess the maternal psychological implication of the novel coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an impact of these implications on the anaesthetic practice.