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 70 of 173Pontificia 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.
Guy's and St Thomas' NHS Foundation Trust
This study aims to find out whether the use of angiotensin II, which is a drug to raise blood pressure has been approved by European Medical Agency in August 2019, as an add-on medication to increase blood pressure in patients with COVID-19, acute severe lung injury, inflammation and severe shock, compared with standard medication. In addition, the investigators will collect the data of Anakinra, another drug which is frequently used in this condition to reduce inflammation. The investigators will collect clinical data and outcomes from critical care patients. The investigators will analyse for whom these drugs are most beneficial and explore whether there are any patients who don't benefit or have side effects.
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
BACKGROUND Despite drastic quarantine measures, COVID-19 continues to propagate and threatens global healthcare systems by saturating their capacity with high transmissibility and the particularly protracted length of stay needed by those requiring intensive care. Indeed, once patients advance to the ICU, prognosis is poor and it is thus critical to test medications that may prevent complications and reduce viral shedding. i.e. to protect ambulatory patients and their families from complications and transmission and allow them to #StayHome. To date, no treatment has been reliably demonstrated as effective in COVID-19 patients. Hydroxychloroquine (HCQ), a common and well tolerated medication, has shown promise in vitro for reducing viral replication (for SARS-CoV-2 as well as other coronaviruses with pandemic potential such as SARS-CoV-1 and MERS). Since then, several small-scale hospital-based clinical studies have indicated the potential for reduced viral shedding and hospitalisation as well as favourable evolution of lung pathology. If started earlier, this treatment could prevent complications requiring hospitalisation and intensive care, which may not be available in low-income countries. Robust clinical trials are required to assess the potential of HCQ in COVID-19. OBJECTIVES This trial assesses the efficacy of early treatment with HCQ in COVID-19 outpatients to reduce the incidence and severity of complications including secondary hospitalisation, ICU admissions, lung pathology and death. Secondarily, this trial will also assess its efficacy to reduce viral transmission among household contacts during self-quarantine. The clinical data collected in this trial will also be critical in creating early prognostication models to better predict healthcare needs and have evidence-based prioritization of resource allocation, which is especially critical in low-resource settings. METHODS The trial will recruit 800 SARS-CoV-2+ patients and their household contacts at triage sites across Switzerland. Patients included are 1) at risk of poor outcome (comorbidities or >65y) and 2) well enough to self-isolate at home. These patients will be randomised 1:1 in HCQ:Placebo and given 6 days of early treatment (within 24 hours of the SARS-CoV-2 test). Intensive pragmatic multiparameter at-home follow-up (including point-of-care lung ultrasound in some sites) will continue until their outcome (resolution, or complications, such as hospitalisation, ICU admission, death). Household contacts will have before and after serological testing and social distancing knowledge and practices questionnaires to assess risk factors for infections. The household attack rate of new-onset infections can then assess the efficacy of HCQ to prevent transmission.
Capricor Inc.
This expanded access protocol will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in critical condition as indicated by life support measurements. Eligible subjects will receive open-label intravenous administration of investigational product (CAP-1002) containing 150 million allogeneic Cardiosphere-Derived Cells (CDCs). CAP-1002 administration will be conducted at the investigative site on Day 1 and weekly up to a maximum of 4 doses, based on clinical course. Subjects will complete protocol assessments at Screening; Day 1; Weeks 1-3; and Follow-up by phone 30 and 90 days after the last infusion. Baseline assessments will be conducted prior to first infusion on Day 1. The patient will be observed during the lengths of hospitalization and monitored for outcome and safety. Safety and outcome data will be collected and reported at the conclusion of treatment and follow-up.
Cardresearch
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in patients with early-onset disease and mild symptoms. Experimental studies have demonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonide and Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggested a reduced complications in patients with COVID-19 disease.
Astana Medical University
Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases
RedHill Biopharma Limited
A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.
Bahçeşehir University
Small molecule inhibitors have previously been investigated in different studies as possible therapeutics in the treatment of SARS-CoV-2. In the current drug repurposing study, the investigators identified the leukotriene (D4) receptor antagonist Montelukast as a novel agent that simultaneously targets two important drug targets of SARS-CoV-2. The investigators initially demonstrated the dual inhibition (main protease and Spike/ACE2) profile of Montelukast through multiscale molecular modeling studies. Next, the investigators characterized its effect on both targets by different in vitro experiments including the Fluorescent Resonance Energy Transfer (FRET)-based main protease enzyme inhibition assay, surface plasmon resonance (SPR) spectroscopy, pseudovirus neutralization on HEK293T / hACE2, and virus neutralization assay using xCELLigence MP real time cell analyzer.
Asan Medical Center
This clinical trial aims to determine if fluvoxamine, a selective serotonin reuptake inhibitor with high affinity for the sigma-1 receptor, can be used in mild to moderate COVID-19 to prevent the progression to severe COVID-19. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder and has a potential for immune modulation as a sigma-1 receptor agonist. The investigational use of fluvoxamine for the treatment of COVID-19 is approved by the South Korean Ministry of Food and Drug Safety. This study is performed fully-remotely at COVID-19 community treatment centers, temporary facilities in Seoul, Korea, to accommodate and monitor asymptomatic to moderately symptomatic case-patients who do not require hospital admission.
Medical University of Graz
Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in the world, especially in terms of health system capacity and economic burden. People from sub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus (HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIV infection and anti-retroviral treatment (ART) in altered cardiovascular risk is questionable and there is still need to further carry out research in this field. However, thus far it is unclear, what impact the COVID-19 co-infection in people living with HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims to investigate whether and how HIV-infection in COVID-19 patients modulates the time course of the disease, alters cardiovascular risk, and changes vascular endothelial function and coagulation parameters/ thrombosis risk. Methods: In this long-term study, cardiovascular research on PLHIV with or without ART with COVID-19 and HIV-negative with COVID-19 will be carried out via clinical and biochemical measurements for cardiovascular risk factors and biomarkers of cardiovascular disease (CVD). Vascular and endothelial function will be measured by brachial artery flow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, and retinal blood vessel analyses, along with vascular endothelial biomarkers and coagualation markers. The correlation between HIV-infection in COVID-19 PLHIV with or without ART and its role in enhancement of cardiovascular risk and endothelial dysfunction will be assessed. Potential changes in these endpoints by COVID-19 will be followed for 4 weeks across the three groups (PLHIVwith or without ART and HIV negatives). Impact of project: The ENDOCOVID project aims to evaluate in the long-term the cardiovascular risk and vascular endothelial function in PLHIV thus revealing an important transitional cardiovascular phenotype in COVID-19.