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 600 of 779University Hospital, Clermont-Ferrand
The hypothesis is that from a cluster defined by a confirmed positive case of COVID-19 and its contact cases, it is possible to study the different expressions and clinical evolutions of COVID-19 infection and to explore the biological profiles related to the observed clinical history. Certain biological determinants (virological, immunological, microbological or gentic) could indeed be correlated with the clinical presentation and/or be useful for personalized care. The main objective is to study the relationship between the biological profiles observed and the clinical evolutions within the same cluster of transmission of the coronavirus SARS-CoV-2 (positive COVID-19 cases and contact subjects).
University of Zurich
This study is meant to assess the lung mechanics in SARS-CoV-2 induced acute respiratory failure. A precise characterisation of lung mechanics and heart-lung-interactions might allow a better understanding of SARS-CoV-2 induced acute respiratory failure and thus lead to better mechanical ventilation strategies. This monocentric, observational study of critically ill COVID-19 patients in the ICU, will employ impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry as well as classic mechanical ventilation parameters to characterise the mechanical characteristics of the lung as well as the heart-lung interactions in SARS-CoV-2 induced acute respiratory failure.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Abstract Title: Randomized,open-label, controlled trial to evaluate efficacy and safety of a highly selective semipermeable membrane (AN69-Oxiris) in comparison with a selective semipermeable membrane ( standard AN69) in COVID-19 associated acute kidney injury: oXAKI-COV study Rationale: Acute kidney injury (AKI) in critically ill mechanically ventilated patients with COVID-19 disease, is present in up to 30% of this group and more than 50% of them will need renal replacement therapy in the form of continuous renal replacement therapy (CRRT). Acute kidney injury in this context seems to be a marker of multiorgan dysfunction and it produces increased mortality in this population. There is a vast amount of mechanisms that lead to AKI in critically ill patients with COVID-19; however, the cytokine storm could be the strongest mechanism implicated in AKI development in individuals with continuous renal replacement therapy requirements. Therefore, blocking or reducing the cytokine storm is thought to be a therapeutic target. Highly selective semipermeable membranes (AN69-Oxiris) have been shown able to adsorb endotoxins and to eliminate inflammatory cytokines, thus representing a valuable therapeutic option in this infection. Objective: To demonstrate clinical efficacy of AN69-Oxiris membrane to reach a stable MAP, with less vasopressor dosing (at least 0.1 micrograms/kg/min) after 72h of treatment, compared to a conventional membrane (standard AN69) in critically ill patients with AKI, COVID-19 infection and requirement of continuous renal replacement therapy. Study design: Randomized,open-label, controlled trial in critically ill patients with suspected or confirmed COVID-19 disease, AKI, and criteria for continuous renal replacement therapy initiation admitted in any of the two participating institutions. Patients meeting inclusion criteria will be randomized to receive CRRT with AN69-Oxiris membrane or standard AN69 membrane during a 72h period.
United Medical Specialties
Determine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.
Gadjah Mada University
Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.
University of Aarhus
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease that has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of April 1, 2020, there are 874.081 numbers of confirmed cases with 43.290 fatalities. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. Key markers implying a fatal outcome are acute respiratory distress syndrome (ARDS)-like disease with pronounced dyspnea, hypoxia and radiological changes in the lung. Senicapoc improves oxygenation and reduces fluid retention, inflammation, and bleeding in the lungs of mice with ARDS-like disease. In cells, there is an antiviral effect of senicapoc.
Nottingham Biomedical Research Centre
This is a prospective observational cohort study that will aim to recruit 60 participants who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay. Potential participants will be approached either by telephone by a member of the research team or via clinics (nephrology, post-ICU follow up clinics).
Enabling Biotechnologies (EB)
This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of COVID-19.
Hadassah Medical Organization
This is a multi-center, open-label study evaluating the safety of Allocetra-OTS, in up to 24 subjects with severe COVID-19 and respiratory dysfunction. Subjects, who will be identified as suffering from COVID-19, will be recruited. After signing an informed consent by the patient and, within 24+6 hours following the time of eligibility (time 0), on Day 1, eligible recipient subjects will receive single intravenous (IV) administration of investigational product as described below. Subjects will be hospitalized for COVID-19, and later as medically indicated. Following the investigational product (IP) administration (Day 1), subjects will be followed for efficacy and safety assessments through 28 days.
Ottawa Heart Institute Research Corporation
The COVID-RASi study is an international randomized clinical trial that will evaluate the potential benefit of angiotensin modulators on clinical outcomes, in COVID-19 patients. The purpose of this study is to determine if renin-angiotensin system inhibitors (RASi), with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), has a beneficial effect in patients with COVID-19 infections, by reducing ICU admission, ventilator requirement or death. We would also like to determine if there are differences between ACEi and ARB therapeutic treatments. With the increasing potential of long COVID symptoms, at the 1 year follow up, a primary endpoint will be the quality of life of study participants, as assessed by ongoing symptoms and/or the standardized questionnaires.