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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There are many scales for screening or assessing the impact of a disease. These scales are generally used to diagnose or assess the severity of a disease and are carried out at the request of a physician by the patient. Conversational agents could make it possible to administer these questionnaires remotely, analyse them and use the results on a large scale, without prior medical intervention. The main objective of this study is to quantify and qualify the distress of a large population in times of pandemic crisis.
Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz
Documentation of all patients undergoing inpatient treatment for SARS-CoV-2 infection with regard to clinical status at admission, medical history, inpatient treatment and course of disease. The aim is to create a risk stratification of the infection on the basis of clinical data as well as therapy and disease progression of the patients. This may also contribute to a better planning of resources.
Kubra Koce, MSc PT
In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. COVID-19 causes a large number of deaths due to its occurrence in many cases. This virus caused a total of 549,461 approved cases and 24,887 deaths worldwide. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared it as "pandemic". Staying home and social isolation are at the top of these precautions. For this purpose, in Turkey on March 21, 2020, '65 and older individuals began to apply the curfew to individuals with chronic illnesses. However, not leaving the house and social isolation brings with it the limitation of physical activity. Physical activity (PA) is defined by WHO as any bodily movement produced by the contraction of skeletal muscles that increases energy consumption. Recommended PA levels for the elderly (≥65 years) are similar to adults (18 to 64 years old). At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. Studies investigating the relationship between social isolation and health behavior report consistent findings. Individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. Practical and innovative interventions are needed to reduce the decline in muscle mass, strength and physical performance in the aging population. When today's conditions are evaluated, technology-supported education programs are effective in increasing the motivation for physical activity. The purpose of this study; to evaluate the physical activity level of individuals over the age of 65 who experience social isolation due to the precautions taken in our country to prevent the spread of the COVID-19 pandemic, and to investigate the effectiveness of home-based telerehabilitation exercises. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.
BioMérieux
The novel coronavirus SARS-CoV-2 (COVID-19) is an emerging respiratory virus that causes pneumonia. WHO data reported admission to the intensive care unit (ICU) for 6% of patients, with a mortality rate reaching 45%. To date, apart from therapeutic trials, ICU management is symptomatic, based on organ failure support therapies. In the initial phase, the therapeutic management also includes empiric antimicrobial therapy (90% of patients, in accordance with LRTI guidelines (ATS 2019) and SRLF Guidelines (2020). One challenge for the ICU physicians is the timing for discontinuation of antimicrobial treatment, especially in case of shock or ARDS, considering that a substantial proportion of COVID-19 pneumonia patients may have pulmonary bacterial coinfection/superinfection. In order to avoid unnecessary prolonged antimicrobial therapy, and subsequent selective pressure, two tests could be combined in a personalized antibiotic strategy: - Procalcitonin (PCT): PCT is a useful tool to guide antibiotics discontinuation in community-acquired pneumonia) and viral pneumonia (PMID24612487). - Respiratory multiplex PCR FA-PPP (Biomérieux®): panel has been enlarged, including 8 viruses and 18 bacteria (quantitative analysis). The turnaround time is short. Sensitivity is high (99%, PMID32179139). It may contribute, in combination with conventional tests, to accelerate and improve the microbiological diagnosis during severe COVID-19 pneumonia. The hypothesize of the study is that the combination of the mPCR FA-PPP and PCT could be used to reduce antibiotics exposure in patients with severe confirmed COVID-19 pneumonia, with a higher clinical efficacy and safety as compared with a conventional strategy.
Assistance Publique - Hôpitaux de Paris
Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +
The recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between patients those who will require specific surveillance and those who can be sent back home. The recent French official recommendation of the French radiology society prescribe that chest X-ray do not have any place in the COVID-19+ management whereas the WHO stipulate that ultrasound machines may be useful for these patients [1-2]. Moreover, scattered recent publications tend to stress the interest of quick ultrasound imaging for COVID-19 suspected patients for screening purpose [2-5]. The aim of this observational historico-prospective study is to assess the risk of severe clinical outcomes (admission in continuous care unit (USC), invasive respiratory assistance, death) in patients suspected or diagnosed COVID-19+ as a function of initial pulmonary ultrasound abnormalities. These clinical outcomes are assessed through phone calls at D5, D15, M1. The secondary objectives are: - Assessing the concordance between the severity of pulmonary lesions as detected by pulmonary ultrasound devices and the ones detected by CT-scanner, for patients who will undergo these two examinations. - Assessing the compared performances in detecting ultrasound pulmonary lesions for patients suspected or diagnosed COVID-19+, between an experimented operator and a newly trained operator. - Evaluate in suspected or COVID-19 patients, the risk of clinical worsening based on pulmonary ultrasound abnormalities during follow-up of hospitalized patients. - Evaluate the ultrasound evolution profiles of pulmonary lesions in patients whose clinical evolution is favorable. - Evaluate the incidence of thromboembolic events in patients who worsen secondarily.
Lady Davis Institute
Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks. Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (> 40% have interstitial lung disease) and common use of immunosuppressant drugs. The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support.
Jessa Hospital
Descriptive prospective study to investigate the prevalence of COVID 19 during ambulant screening
Istanbul University - Cerrahpasa (IUC)
Both influenza and coronaviruses cause respiratory infections, which can lead to morbidity and mortality, especially in those who are immunocompromised or not immune to viruses (Zhu). Physical exercise has many effects on the human body, including the immune system. Moderate exercise appears to have a beneficial effect on immune function, which can protect against upper respiratory infections. Human being is a social entity by nature and social isolation can negatively affect individuals' psychology. There are many studies examining the effect of physical activity on the mental state of people. The World Health Organization (WHO) suggests individual protection measures such as establishing necessary hygienic conditions, ensuring social isolation and keeping immune system strong against the complications that may develop due to Coronavirus.Human being is a social entity by nature and social isolation can negatively affect individuals' psychology. There are many studies examining the effect of physical activity on the mental state of people. Different theories which claims the psychological improvements resulting from the increased levels of physical activity have also been proposed in the literature.Regular aerobic exercise and walking can not only improve the emotional state of the individuals, but may also affect the mental health by avoiding the negative thoughts and adapting to stress. The aim of this study is to increase the physical activity level, psychological condition and physical well-being with video-based exercises.
IVAN J NUÑEZ GIL
The investigators propose to select all COVID 19 patients attended in any health center (with in hospital beds), who have been discharged or have died at the time of the evaluation. The main objective of the present study is to carefully characterize the clinical profile of patients infected with COVID-19 in order to develop a simple prognostic clinical score allowing, in selected cases, rapid logistic decision making (discharge with follow-up, referral to provisional/field hospitals or admission to more complex hospital centers). As secondary objectives, the analysis of the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed.
University of Missouri-Columbia
Currently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV who have not achieved viral suppression through antiretroviral treatment may have a compromised immune system that leaves them vulnerable to infections and disease progression. However, little is known about the presentation and clinical outcomes of patients with HIV and SARS-CoV-2. Our aim is to characterize the clinical presentation and disease course of COVID-19 in patients with HIV.