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 30 of 184Louisiana State University Health Sciences Center in New Orleans
Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory infection, emerging data show that morbidity and mortality are driven by disseminated intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing multiple systems organ failure and consuming enormous healthcare resources. Identifying strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates. The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis. The purpose of the proposed multi-center, prospective, randomized controlled trial is to test the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can mitigate the prothrombotic state and reduce hospitalization rates.
Max Healthcare Insititute Limited
1. To understand the prevalence of symptoms of Depression and Anxiety in general population during COVID-19 in India 2. To understand correlation between COVID-19 related factors and mental health symptomology in the general population in India Hypothesis: There is likelihood of significant symptoms of depression and anxiety among general population in India during the current COVID-19 outbreak. Procedure: The participants would be selected with their informed consent. The objective of the study would be clearly written on Page 1 of the survey. The test would be administered electronically by all the participants individually only when consented to the study. The data collected will be kept strictly confidential and the identity of the participants will not be disclosed at any point of the research Measures: 1. Demographic Information Demographic variables included Gender, Age, Place of Stay, Marital Status, Highest Level ofEducation, current living arrangement (e.g. staying alone or with family) and Occupation. It further includesregular employment status and current employment status(e.g, Work from home, temporary leave, termination etc) 2. History of illness (Present or past) History of physical ailment specified (diabetes, hypertension, heart ailment or being on any steroid or any other chronic ailment) Previous history of H1N1/ Influenza like illness 3. COVID-19 Information This section includes time spent focusing on COVID related information, current stressors with respect to COVID-19 and coping mechanisms used. This further includesinformation on resources available to participants near their place of stay and information of any known diagnosed case of COVID-19. 4. Standardized Scales to be used Generalized Anxiety Disorder Scale (GAD-7); Patient Health Questionnaire (PHQ-9) Powered by
China-Japan Friendship Hospital
The noval coronavirus disease 2019 (COVID-19) would cause physical and psychological dysfunctions in infected patients. We expect that an intelligence-based remote pulmonary rehabilitation scheme could improve patients' health status after hospital discharge. The intelligence-based remote pulmonary rehabilitation program is designed in a real-world and prospective manner, aiming to evaluate the efficacy of rehabilitation among 200 patients in the epicenter of China (Wuhan City) according to their varied adherence. An eight-week rehabilitation scheme, including two weeks for physicians and physiotherapists remotely guided training, and six weeks for patient self-management, will be addressed. The primary outcome of current study is six-minute walking distance and lung function, and secondly respiratory muscle strength, physical fitness assessment, symptoms and quality of life, etc. will also be assessed. Recruited patients will be followed up at week 2, 4, 8 after enrollment and at month 1, 3, 6, 12 after the rehabilitation training completed, respectively. The study has been approved by the ethics committee of China-Japan Friendship Hospital and three participating centers in Wuhan City.
Columbia University
The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.
Hôpital Cochin
This study evaluates the effects of the addition of chlorpromazine to the standard therapeutic protocol in COVID-19 patients hospitalized for respiratory symptom management (score 3-5 WHO Ordinal Scale for Clinical Improvement).
Assistance Publique - Hôpitaux de Paris
Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients. PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).
Karolinska Institutet
The purpose of this study is to investigate if a brief online-delivered cognitive-behavioral intervention can reduce the degree of dysfunctional worry related to the Covid-19 pandemic, compared to a wait-list control condition.
Kantonsspital Winterthur KSW
This study aims to observe the long-term health-related quality of life (HRQOL) and physical performance in individuals hospitalized due to a COVID-19 infection. Therefore, data is extracted from a study-site standard aftercare program which has been adjusted for this patient population. This comprehensive aftercare program includes education sessions and physical exercise. A second aim is to observe adherence and feasibility to the program and if indicated compare the clinical data and outcomes from patients following the program with patients denying to participate in guided exercise and education sessions. It is expected that patients hospitalized due to COVID-19 infection show a reduction in physical performance and HRQOL directly after discharge. The severity of illness is hypothesized to be associated with a reduction as well in HRQOL and physical performance after one-year post-discharge.
Selfapy GmbH
The COVID-19 pandemic leads to a greatly increased risk of substantial psychological stress worldwide. We intend to evaluate an online support program aiming at reducing stress in the context of the COVID-19 pandemic. The program consists of twelve modules that participants undergo, covering a broad range of topics related to stress in the context of the COVID-19 pandemic. It has been developed together with and is provided by Selfapy GmbH, Berlin. The aim of this randomised clinical trial with observational components is to estimate the effects of the intervention as a whole, as well as individual modules and selected chapters. Further, follow-up assessments as well as information on risks and the long-term course of COVID pandemic-related stress may help to elucidate COVID-19 pandemic stress across time and what we can do to prevent long-term negative consequences.
University of Palermo
Different studies showed that ascorbic acid (vitaminC) positively affects the development and maturation of T-lymphocytes, in particular NK (natural Killer) cells involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of systemic inflammatory syndrome. Recent studies have also demonstrated the effectiveness of vitamin C administration in terms of reducing mortality, in patients with sepsis hospitalized in intensive care wards. Given this background, in the light of the current COVID-19 emergency, since the investigators cannot carry out a randomized controlled trial, it is their intention to conduct a study in the cohort of hospitalized patients with covid-19 pneumonia, administering 10 gr of vitamin C intravenously in addition to conventional therapy.