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 120 of 413Children's Hospital Medical Center, Cincinnati
The purpose of this research study is 1) to conduct a prospective longitudinal surveillance research trial, enrolling up to 200 CCHMC employees as they come back to work, and then following their clinical and laboratory parameters for up to 12 months; and 2) to support the ongoing development of diagnostic techniques for COVID-19. The overall goal is to investigate patterns of SARS-COV-2 infection, including immunological recovery and genetic risk factors, among CCHMC employees to better understand how to safely reintroduce the CCHMC work force back into their normal routines.
InCor Heart Institute
This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.
University of Utah
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
City of Hope Medical Center
Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.
Surgical Systems Research Group
To respond to the COVID-19 pandemic, investigators will be deploying community health workers, equipped with mobile technology, and accompanied by youth to visit households door to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of COVID-19. The community health workers and youth will educate households about preventive measures including frequent handwashing and home management of mild cases. Simultaneously, investigators will work with nurses, doctors, and clinical officers, to test and treat more severe cases of COVID-19 in health facilities. Our goals are: to visit every household in Siaya county covering a population of close to 1 million, and to train and support health workers working in 32 health facilities with oxygen capacity in Siaya to reduce the morbidity and mortality related to COVID19 and other conditions.
National Institute of Allergy and Infectious Diseases (NIAID)
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
Pontificia Universidad Javeriana
Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies, which is related to the decrease in the severity of the clinical picture and suppression of inflammation. This suppression of inflammation may be related to the inhibition of NF-kB polyphenols, where its activation is related to the stimulation of 150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other additional mechanisms that can help control virus-induced respiratory pathologies, among which are the regulation of reactive oxygen species (ROS) associated with tissue destruction caused by the virus and a selective antiviral action can be reported. direct. The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data). These antecedents suggest that the supplementation of patients with COVID-19 with the extract P2Et, could improve their general condition and decrease the inflammatory mediators and the viral load.
University of Zurich
In light of the rapidly emerging pandemic of SARS-CoV-2 infections, the global population and health care systems are facing unprecedented challenges through the combination of transmission and the potential for severe disease. Acute respiratory distress syndrome (ARDS) has been found with unusual clinical features dominated by substantial alveolar fluid load. It is unknown whether this is primarily caused by endothelial dysfunction leading to capillary leakage or direct virus induced damage. This knowledge gap is significant because the initial balance between fluid management and circulatory support appear to be decisive. On progression of the disease, bacterial superinfection facilitated by inflammation and virus related damage, has been identified as the main factor for patient outcome, but the role of the host versus the environment microbiome remains unclear. The overarching aim of the present research proposal is to improve therapeutic strategies in critically ill patients with ARDS due to SARS-CoV-2 infection by advancing the pathophysiological understanding of this novel disease. This research thus focuses on inflammation, microcirculatory dysfunction and superinfection, aiming to elucidate risk factors (RF) for the development of severe ARDS in SARS-CoV-2 infected patients and contribute to the rationale for therapeutic strategies. The hypotheses are that (I) the primary damage to the lung in SARS-CoV-2 ARDS is mediated through an exaggerated pro-inflammatory response causing primary endothelial dysfunction, and subsequently acting two-fold on the degradation of the lung parenchyma - through the primary cytokine response, and through recruitment of the inflammatory-monocyte-lymphocyte-neutrophil axis. The pronounced inflammation and primary damage to the lung disrupts the pulmonary microbiome, leading secondarily to pulmonary superinfections. (II) Pulmonary bacterial superinfections are a significant cause of morbidity and mortality in COVID-19 patients. Pathogen colonization main Risk Factor for lower respiratory tract infections. To establish colonization, pathogens have to interact with the local microbiota (a.k.a. microbiome) and certain microbiome profiles will be more resistant to pathogen invasion. Finally, (III) Handheld devices used in clinical routine are a potential reservoir and carrier of both, SARS-CoV-2, as well as bacteria causing nosocomial pneumonia.
Federal University of Rio Grande do Sul
Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (SARS-CoV-2) that can progress to severe disease requiring hospitalization and oxygen support in around14% of the cases and 5% require admission in intensive care unit. The medium and long-term impact in survivors of severe COVID-19 on lung function, exercise capacity and health-related quality of life remains to be determined.
Rigshospitalet, Denmark
The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.