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 1040 of 1332St. Mary's Research Center, Canada
During pandemics older adults with chronic physical conditions are a particularly vulnerable population for unmet mental health needs. This is a consequence of a number of factors which include decreased access to their doctors because of restrictions in visits in order to decrease risk of disease transmission and because doctors are seconded to provide medical services in areas of high priority. Since Public Health authorities worry that pandemics may be a reality of the future, this study is being operationalized during the present COVID-19 pandemic in order to see what can be learned about different ways to provide mental health care under such constraints. The study offers evidence-based approaches to managing feelings of anxiety or depression that may have existed prior to the onset of a pandemic, or that have arisen during a pandemic. It uses principles of cognitive behavioural therapy in which participants are offered self-care tools to help them develop strategies for dealing with their various symptoms. These tools have already been shown by the team to be effective in other contexts in studies DIRECT-sc (Effectiveness of a supported self-care intervention for depression compared to an unsupported intervention in older adults with chronic physical illnesses) and CanDIRECT (Effectiveness of a telephone-supported depression self-care intervention for cancer survivors). The present study, PanDIRECT (Assisting Family Physicians with Gaps in Mental Health Care Generated by the COVID-19 Pandemic), aims to answer the following questions: 1. Can these tools be used in the community care of mental health problems during pandemics? 2. Are they acceptable to patients? 3. Using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes? 4. Do family practitioners value patient information sent to them at the end of the trial
Debiopharm International SA
COVID-19 is a viral respiratory and systemic disease that has been rapidly spreading globally since the first cases were reported in December 2019 and has now become pandemic. The causative agent of COVID-19 was identified as a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, first designated as 2019-nCoV). The disease manifestations of COVID-19 can range from mild, self-resolving respiratory disease to severe pneumonia, ARDS, multiorgan failure, and ultimately death. In early reports, the mortality rate among patients admitted to hospital and with confirmed SARS-CoV-2 infection was reported to be between 4 and 15%. Although the disease can afflict all age groups, elderly patients and patients with underlying comorbidities such as high body mass index, hypertension, diabetes, cardiovascular disease, or cerebrovascular disease are at risk of developing severe disease and dying. There are currently no etiologic treatments for COVID-19, and efforts are underway to identify therapeutics that could be effective in controlling this disease.
Israel Institute for Biological Research (IIBR)
The SARS-CoV-2 virus is responsible for the COVID-19 pandemic. The pandemic emerged from Wuhan Province in China in December 2019 and was declared by the WHO Director-General a Public Health Emergency of International Concern on 30 January 2020. In this study, a vaccine developed by IIBR for SARS-CoV-2 virus will be assessed for its safety and potential efficacy in volunteers. The study is comprised of two phases, a dose-escalation phase (phase I) during which subjects (18-55 years old) will be randomly allocated to receive a single administration of IIBR-100 100 at low, mid or high dose or saline or two administrations of IIBR-100 at low dose, or saline, 28 days apart. Based on results obtained during phase I, and cumulative phase I data review, the expansion phase (phase II) has begun, during which larger cohorts as well as elderly age subjects will be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline, or two administrations of IIBR-100 at low, mid or high dose (prime-boost) or saline, 28 days apart. Additional top-dose (prime-boost) may be implemented when immunogenicity of any prime-boost arm is considered insufficient. Based on immunogenicity preliminary data and DSMB recommendations, the two administrations of mid, high and top dose (prime-boost) or saline will continue. The subjects will be followed for a period of up to 12 months post last vaccine administration to assess the safety and efficacy of the vaccine.
Institut Pasteur
The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2. It is a case-control study including : - cases identified by the nationwide system of positive SARS-CoV-2 tests (COVID-19 diagnosis information system, SIDEP) (currently limited to qRT-PCR) and invited to participate by the National Health Insurance (CNAM) which hosts the data from the nationwide test system; - controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories), gender and geographic area (departement); - cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls. Data will be collected via a self-administered online questionnaire. Some of the participants will be called for a complementary telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.
Assistance Publique - Hôpitaux de Paris
The aim of the study is to search the presence of the SARS-COV-2 virus (COVID19) in the pneumoperitoneum of patients with a positive (or suspected) COVID19 status during a routine laparoscopy.
Centre for Addiction and Mental Health
The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for type 2 diabetes designed to support patients with diabetes and mental health concerns during COVID-19.
Uppsala University
This feasibility study aims to adapt a protocol usually run in the laboratory in the Psychology Department for healthy participants (including the trauma film paradigm (James et al., 2016) and a simple cognitive task intervention) to remote (online) delivery. The motivation for this was restrictions to running in person laboratory experiments during the COVID-19 pandemic. Participants will view film footage with COVID-19 related and potentially traumatic content (e.g. of seriously ill or dying patients in hospitals). Following film viewing, participants will be randomly allocated to either the experimental condition (simple cognitive task intervention, i.e. a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) or the control condition (attention placebo, i.e., a memory cue followed by listening to a podcast for a similar duration). Any intrusive memories induced by the film (analogue trauma) will be monitored in a daily diary. It is predicted that the film (analogue trauma) will generate intrusive memories. If intrusive memories are generated, then it is predicted that participants in the experimental condition will report fewer intrusive memories related to the film (analogue trauma) during the following week than participants in the control condition. The development of this paradigm may inform the future development of a simple technique to prevent intrusive memories e.g. after repeated media consumption related to the COVID-19 pandemic.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
In December 2019 the first case of human infection by a new coronavirus was identified, currently called SARS-COV-2 (Severe Acute Respiratory Syndrome - Coronavirus - 2), characterized by high contagiousness and the possibility of causing a severe acute respiratory distress syndrome from which its acronym derives and which caused the state of a global pandemic in a few months. The most frequent clinical manifestation of COVID-19 is pneumonia, which in about 20% of cases results in acute respiratory failure. Very few studies have so far addressed the problem of clinical and functional recovery in these patients, most of them just before or after discharge and none specifically focused on patients admitted for ARF. Indeed most of these investigations were limited to a specific field such as symptoms, pulmonary function and radiological changes. There are no guidelines for the follow-up of COVID-19 patients, despite the British Thoracic Society (BTS) has published a guidance for scheduling post-hospitalization assessments. Aim of this study is to describe the long term (6 to 12 months) evolution of lung involvement in patients discharged after an episode of ARF due to COVID-19, identifying possible factor associated to lasting clinical, functional or radiological abnormalities collecting data from hospital stay, 1-month after hospital discharge, 3-months after hospital discharge and 6-to-12-months after hospital discharge.
Ampio Pharmaceuticals. Inc.
This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.
South Valley University
Antiviral efficacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks