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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To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 990 of 1301Hospital Reg. Lic. Adolfo Lopez Mateos
Within the epidemic context of phase 3 in Mexico, the implementation of new treatments that have been shown to be beneficial for patients in other countries is an urgent need. Methylene blue (MB, the oxidized form, blue color) has been used in many different clinical medicine areas, ranging from malaria to orthopedics. Methylene blue absorbs energy directly from a light source and then transfers this energy to molecules of oxygen creating singlet oxygen (O2), which is the first electronic excited state of molecular oxygen (O2). Singlet oxygen is extremely electrophilic; thus, it can directly oxidize electron-rich double bonds in biological molecules and macromolecules. For this reason, methylene blue has been used as a photosensitizer in the treatment of cancer and the protection of serum from viral agents. Methylene blue can be reactivated using energy from a light source in the body until processed out through the kidneys.
Assistance Publique - Hôpitaux de Paris
Vascular leakage following endothelial injury, responsible for interstitial and alveolar edema, is a major feature of pathogen induced acute lung injury. As acute respiratory distress syndrome (ARDS) due to pandemic Covid-19 is associated with more than 60% mortality, controlling vascular leakage may be a major target to decrease the mortality associated with the spreading of the disease in France. FX06, a drug under clinical development containing fibrin-derived peptide beta15-42, is able to stabilize cell-cell interactions, thereby reducing vascular leak and mortality in several animal models, particularly during lipopolysaccharide-induced and dengue hemorrhagic shock . A phase I study was conducted in humans, with no specific adverse event detected with a dose up to 17.5 mg/kg. In a phase II randomized multicentre double-blinded trial in 234 patients suffering from ST+ acute coronary syndrome, FX06 treated patients exhibited a 58% decrease in the early necrotic core zone. Importantly, adverse events were highly comparable between groups, indicating a high safety profile for the drug . Lastly, the drug was used as a salvage therapy in a patient exhibiting a severe ARDS following EBOLA virus infection . Altogether, those data indicate that FX06 is well tolerated in humans and is a potent regulator of vascular leakage. Our hypothesis here is that FX06 may decrease pulmonary vascular hyperpermeability during ARDS following SARS-CoV-2 infection, thereby improving gas exchanges and the outcome of infected patients.
Makerere University
Introduction: During pandemics like the COVID-19, a significant number of the populace suffer from psychological distress (PD) that often abates naturally over time in the majority of people but persists in others to become pervasive and severe enough to trigger the onset of common mental disorders (CMD) like major depressive disorders (MDD), generalized anxiety disorders (GAD), post-traumatic stress disorders (PTSD) and substance misuse disorders (SUD). Once identified, psychological distress as well as CMD can be managed using psychotherapy or pharmacotherapy. However, low levels of mental health literacy (MHL) manifested by the individual's unawareness of CMD symptoms, limited human and mental health infrastructure resources and high levels of mental illness stigma (MIS), are barriers to integration of mental health care in general health care during pandemics and epidemics such as the COVID-19. The study objectives will include: (a) Documenting MHL, PD, MDD, GAD, PTSD and SUD levels in the study population, (b) Determining the effectiveness of a psycho-education intervention delivered by village health team (VHT) members on study outcomes Methods: We shall employ an open label cluster-randomized trial design, with each village as a cluster, to conduct the study in 24 villages (12 intervention and 12 control villages) in Kampala (n= 15), Wakiso (n= 3), Masaka (n= 2) and Mukono (n= 4) districts. To ensure balance between the two study arms, villages underwent stratified randomization on the basis of rural vs urban population. The second level of stratification will be achieved by a separate randomization procedure performed within each stratum to ensure gender balance within each cluster We will develop information education and communication materials (IEC) aimed at improving MHL and reducing MIS. In the intervention arm (n=12 villages), VHTs will distribute the IEC materials in every 12th household till they accrue 420 individuals (adults ≥ 18 years old) who express interest in participating in the study. In the control arm (n=12 villages), VHTs will distribute MOH COVID-19 information leaflets in every 12th household till they accrue 420 individuals who express interest in participating in the study. Within 7days after distribution of the materials, trained research assistants will schedule and assess participants (through a phone interview) for MHL, PD, MDD, GAD, PTSD and SUD. Individuals who don't have phones will be asked to provide a phone number of a friend or relative through which the interviews can be conducted; interviews could also be conducted using the VHTs' phone. Cost data will be collected using available implementation data. We will document the number of individuals from both arms who will contact the investigators Data analysis plans: We will (a) report frequencies and percentages and their 95% confidence intervals for the first objective, (b) use an intention to treat analysis to analyze the second objective, Conclusion: Findings from this research will guide policy and practice regarding the integration of mental health services in the community in the context of epidemic preparedness and response.
Sharp HealthCare
The purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.
San Bortolo Hospital - Vicenza
The novel coronavirus disease (COVID-19) is posing a serious challenge to the health-care systems worldwide, with an enormous impact on health conditions and loss of lives. More than 30 millions of recoveries worldwide were registered at the end of October 2020 with more than 1 million of deaths. As the disease continues to spread, strategies aimed to reduce hospitalization time in sub intensive unit care, thus reducing pressure on health system, but also to reduce some of the pathological features of COVID-19 such as inflammation and the "cytokines storm". The ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes a physiological ketosis (due to an increase of liver ketone bodies production). High fat, low carbohydrate diets have been shown to reduce duration of ventilator support and partial pressure carbon dioxide in patients with acute respiratory failure. Moreover, the physiological increase in plasma levels of ketone bodies exerts important anti-inflammatory and immunomodulating effects, which may reveal as precious tools to reduce potential adverse outcomes of COVID-19 disease. The hypothesis of this study is that the administration of a ketogenic diet will improve gas exchange, reduce inflammation, and the duration of hospitalization. The plan is to enrol 28 patients with diagnosis of COVID-19 hospitalized but not in ICU with SPO2 higher than 88%.
Agency for Healthcare Research and Quality (AHRQ)
This will be a randomized control trial assessing the impact of CRI:SIS as a simulation-based preparedness intervention on physician stress levels through changes to heart rate variability (HRV) on shift while caring for COVID-19 patients and post-shift anxiety as measured by the State-Trait Anxiety Inventory (STAI). The aim is to test CRI:SIS to determine its effect on mitigating physician stress on shift and anxiety post-shift related to provision of COVID-19 care
University of Lethbridge
There is an immediate need for population-level intervention research to address the impacts of the coronavirus disease 2019 (COVID-19) pandemic and its containment measures on mental health and substance use (MHSU). While online programs are available to address these issues, they are often delivered in an asynchronous format with relatively low therapist or health coaching guidance. As highlighted by a recent systematic review, positive outcomes for online mental health programs are tied to the intensity of therapist or coaching guidance, which increases cost and reduces population access to more effective online options. A way to offset cost while maintaining effectiveness is to offer MHSU programs to groups online, rather than individually. In 2019, the investigators launched an RCT to test gender-stratified group interventions to address MHSU among community-based Indigenous and non-Indigenous adults in southern Alberta. The investigators implemented the interventions with more than 200 adults before the study was paused due to COVID-19.
Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia
The benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.
Harvard Pilgrim Health Care
In addition to its impact on health, the COVID-19 pandemic led to increased unemployment and loss of employer-sponsored insurance coverage. Obtaining coverage can be challenging and eligibility for public programs and subsidies can be limited, and those who do not qualify can face steep premiums, high-deductibles, and high out-of-pocket costs. Disruptions to employment and insurance coverage during the pandemic threaten to negatively affect asthma care and outcomes. Our parent project, Asthma in Families Facing Out-of-pocket Requirements with Deductibles (AFFORD), found that patients with asthma may be particularly vulnerable to insurance-related cost barriers and challenges navigating health insurance. Together with the Asthma and Allergy Foundation of America (AAFA), the investigators developed an asthma chat bot to help patients with asthma navigate insurance benefits and optimize health care decisions. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage and how to find lower-cost alternatives for asthma care. In this supplement to the AFFORD project, the investigators propose a new study to understand and address the insurance and health care cost challenges faced by patients with asthma who lose employer-sponsored coverage due to COVID-19. Our Aims are: 1) to conduct a pilot randomized controlled trial to evaluate the effectiveness and feasibility and acceptability of an insurance navigation intervention, including the chat bot, to help patients with asthma regain coverage after the loss of job-related insurance during the COVID-19 pandemic; and 2) to qualitatively explore the experiences of Aim 1 participants to understand barriers and facilitators to accessing coverage and asthma care more broadly during the COVID-19 pandemic The study hypothesis is that participants receiving the intervention will be more likely to have coverage after four months and less likely to report non-adherence to asthma medications, delayed/forgone asthma care, and financial burden than those receiving usual care. Findings will provide evidence about the effectiveness of strategies to obtain coverage and maintain access to affordable asthma care and can inform ongoing and future decision making in response to the COVID-19 pandemic and other public health and economic threats.
Instituto de Terapia Celular: ITC
The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.