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 170 of 237Canadian VIGOUR Centre
While many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs. The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness. The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test). The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
The study objectives were to assess 1/the immune status of healthcare professionals with suggestive symptomatology of Covid-19 infection and 2/the sensitivity and specificity of AAZ rapid test by comparing it with a serological ELISA test. An open-label, monocentric, prospective, non-randomized study, is conducted, including 50 hospital healthcare professionals and 50 private health professionals. Knowledge of serostatus will achieve the implementation of a strategy of management of patients according to specific immunity of health professionals
Hôpital Raymond Poincaré
Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.
University of Milano Bicocca
In Italy there are about 5000 patients with dependent transfusion thalassemia (source Italian Thalassemia and Hemoglobinopathies - SITE) and a smaller number, currently not definable, of patients with sickle cell anemia in chronic transfusion. A recent study in the Lombardy region identified the positivity of anti-Covid-19 antibodies in 4.5-7% of asymptomatic donors (Valenti L et al). As already known, a preliminary study conducted in Italy (Motta I et al, Hussain FA et al, Taher A et al) reported only 11 cases of symptomatic infection all with benign evolution. Currently there are 15 reported cases (12 thalassemias and 3 sickle cell anemias). 75% of the cases have been identified in Lombardy. Our hypothesis is that in a percentage of polytransfused patients a transmission of the virus may have developed that stimulated the production of protective antibodies. This could be an explanation of the low contagiousness and severity of the infection in polytransfused patients. Currently no data are available for this purpose. This study will be conducted in collaboration with the Microbiology Unit and involves the determination of SARS-CoV-2 antibodies (anti-s1 and s2) by CLIA method with a high sensitivity (94.7%) and specificity (98.5%).
Sahlgrenska University Hospital, Sweden
Cardiac dysfunction has been reported to be common in patients infected with COVID-19. The aim of this study is to evaluate the clinical importance of cardiac dysfunction in critically ill patients infected with COVID-19.
University Hospital, Basel, Switzerland
The proportion of asymptomatic carriers of SARS-CoV-2 remains elusive, so the potential benefit of systematic screening during the SARS-CoV-2-pandemic is controversial. We investigate the proportion of asymptomatic inpatients who were identified by systematic screening for SARS-CoV-2 upon hospital admission. Adult patients admitted to the University Hospital Basel from 01.04.-14.06.2020 were routinely tested for SARS-CoV-2 within 72 hours of admission by nasopharyngeal swabs. Each patient screened during the study period was retrospectively classified symptomatic or asymptomatic for COVID-19 based on medical chart review.
Ambry Genetics
This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.
Direction Centrale du Service de Santé des Armées
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel
Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission is by droplet route, with an R0 of approximately 3. Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions. Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced. During the period of containment, the majority of students from the Lyon-Bron Military Medical Schools were sent as reinforcement in Army Training Hospitals and in the Military Reanimation Unit (Mulhouse). Some students developed symptomatic forms of SARS-Cov-2 infection, documented by positive PCR, during Operation Resilience or on their return from the mission. The Lyon-Bron Military Medical Schools staff, exposed both to the initial phase of the epidemic and to national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus.
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Evaluating the rate of exposure to the virus in the close contact population who shared the home of a person infected with SARS-CoV-2 at the time of infection of the index case - adults or children - is a major factor in assessing the spread. virus in the family environment, assess the factors of circulation and determine whether immunity has been acquired. Screening for specific antibodies to SARS-CoV-2 will determine the exposure and protection acquired against this virus. Knowing the intra-family secondary transmission rate is essential for supporting the strategies for lifting the confinement envisaged and implementing a personalized approach. As of March 8, a platform for the home management of COVID + patients was set up when they, pauci or moderately symptomatic, do not require hospitalization. As of May 6, 2020, 881 patients have been registered in COVID and followed, constituting the active COVIDOM / PSL file. Of the 512 patients included between March 1 and 31, 45% have a household consisting of 3 people. All patients had weekly clinical follow-up by telephone for the duration of the disease with a maximum of 4 weeks having been achieved. If the recommendations of barrier gestures, isolation in an apartment were made during the symptomatic phase, the absence of masks available to all did not allow, in practice, to achieve the isolation and quarantine recommended ideally. to break the transmission of the virus. The FAMI-CoV study proposes to assess the rate of exposure to the virus in contacts sharing the same focus of index cases. A sub-study will assess the proportion of antibodies that have been neutralizing.
Centre Antoine Lacassagne
Study Rational Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. First data report high mortality in severe patients with 30% death rate at 28 days. Exact proportions of the reasons of death are unclear: severe respiratory distress syndrome is mainly reported which can be related to massive cell destruction by the virus, bacterial surinfection, cardiomyopathy or pulmonary embolism. The exact proportion of all these causes is unknown and venous thromboembolism could be a major cause because of the massive inflammation reported during COVID-19. High levels of D-dimers and fibrin degradation products are associated with increased risk of mortality and some authors suggest a possible occurrence of venous thromboembolism (VTE) during COVID-19. Indeed, COVID-19 infected patients are likely at increased risk of VTE. In a multicenter retrospective cohort study from China, elevated D-dimers levels (>1g/L) were strongly associated with in-hospital death, even after multivariable adjustment. Also, interestingly,the prophylactic administration of anticoagulant treatment was associated with decreased mortality in a cohort of 449 patients, with a positive effect in patients with coagulopathy (sepsis-induced coagulopathy score ≥ 4) reducing the 28 days mortality rate (32.8% versus 52.4%, p=0.01). However the presence/prevalence of VTE disease is unknown in COVID-19 cancer patients with either mild or severe disease. Cancer patients are at a higher risk of VTE than general population (x6 times) and could be consequently at a further higher of VTE during COVID-19, in comparison with non-cancer patients. The exact rate of VTE and pulmonary embolism during COVID-19 was never evaluated, especially in cancer patients, and is of importance in order to understand if this disease needs appropriate prophylaxis against VTE. The largest series of cancer patients so far included 28 COVID-19 infected cancer patients: the rate of mortality was 28.6%. 78.6% of them needed oxygen therapy, 35.7% of them mechanical ventilation. Pulmonary embolism was suspected in some patients but not investigated due to the severity of the disease and renal insufficiency, reflecting the lack of data in this situation. The aim of the present study is to analyze the rate of symptomatic/occult VTE in a cohort of patients with cancer. Expected benefits Anticipated benefits of the research are the detection of VTE in order to treat it for the included patient. For all COVID-19 positive cancer patients it will enable to provide some guidelines and determine which patient are at risk for VTE and which will need ultrasound to detect occult VTE. Foreseeable risks Foreseeable risks for patients are non-significant because the additional procedures needed are ultrasound exam, and blood sample test. Methodology Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection. Indeed, because the outbreak can end within the next 3-6 months, Investigators may not be able to answer the question if Investigators only focus on patients investigated prospectively. Investigators then decided to include patients from medical team who are already systemically screening patients with COVID-19 disease for VTE. Trial objectives Main objective To evaluate the rate of venous thromboembolism at 23 days during COVID-19 infection in cancer patients.