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 890 of 979University of Trieste
Low-dose glucocorticoid treatment is the only intervention shown to significantly reduce mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support. In particular, a large UK randomized controlled trial (RECOVERY trial) demonstrated the efficacy of dexamethasone at a dosage of 6mg/day for 10 days in reducing mortality compared to usual therapy, with a greater impact on patients requiring mechanical ventilation (36% reduction) or oxygen therapy (18% reduction) than on those who did not need respiratory support (doi: 10.1056/NEJMoa2021436). However, there is still paucity of information guiding glucocorticoid administration in severe pneumonia/ARDS and no evidence of the superiority of a steroid drug -nor of a therapeutic scheme- compared to the others, which led to a great heterogeneity of treatment protocols and misinterpretation of available findings. In a recent longitudinal observational study conducted in Italian respiratory high-dependency units, a protocol with prolonged low-dose methylprednisolone demonstrated a 71% reduction in mortality and the achievement of other secondary endpoints such as an increase in ventilation-free days by study day 28 in a subgroup of patients with severe pneumonia and high levels of systemic inflammation (doi: 10.1093/ofid/ofaa421). The treatment was well tolerated and did not affect viral shedding from the airways. In light of these data, the present study aims to compare the efficacy of a methylprednisolone protocol and that of a dexamethasone protocol based on previous evidence in increasing survival by day 28, as well as in reducing the need and duration for mechanical ventilation, among hospitalized patients requiring noninvasive respiratory support (oxygen supplementation and/or noninvasive ventilation).
Laboratoires SMB S.A.
The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Jessa Hospital
Follow-up of patients with a borderline PCR result. Data of patients that were re-tested within 96 hours after receiving a borderline COVID-19 PCR result are reviewed. This is a retrospective study.
University Hospital, Bordeaux
The aim of this study is to assess the prevalence and arrhythmogenic role of occult myocardial scars on Cardiac Magnetic Resonance (CMR) in a population of patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization, as compared to a population of age- and sex-matched healthy volunteers.
Erasme University Hospital
The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that could be altered in COVID-19 patient and its supplementation may potentially helpful in this setting.
University Hospital, Grenoble
SARS-CoV-2 is the agent responsible for a new infectious respiratory disease called Covid-19 (for CoronaVirus Disease 2019) which is mainly characterized by potentially severe and fatal lung damage. The severity of the clinical signs associated with this pathology requires the admission to hospital of approximately 20% of patients, 5%-10% of whom will be admitted to intensive care. The most severe cases of this pathology begin with dyspnea which worsens rapidly around the 7th-10th day of the disease into an acute respiratory distress syndrome (ARDS) which requires the patient to be put under mechanical ventilation in the intensive care unit and is responsible for the majority of deaths. Certain biological parameters suggest a massive and brutal release of cytokines (interleukins IL-6, IL-8 and IL-10 mainly) secondary to a syndrome of macrophagic activation mainly in the pulmonary level. Several therapeutic trials aimed at reducing or controlling this immune storm are in progress (anti IL-6 antibodies, anti r IL6 Ab, corticosteroids). Molecular hydrogen acts on the final path of this complex inflammatory cascade by inhibiting the cellular action of reactive oxygen species. Its early use combined with nasal oxygen therapy could prevent this worsening of the respiratory system, so could be likely to limit the risk of overflow of intensive care services during the pandemic and save lives. The aim of this study is to evaluate the safety and the Dose Limiting Toxicity (DLT) of hydrogen therapy delivered by a nasal cannula in addition to conventional oxygen therapy in patients with moderate Covid-19
Eli Lilly and Company
The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.
University of Cologne
This is the first-in-human phase 1/2a trial of the inhaled administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.
University Hospital, Angers
Hypothesis: The apelin/APJ system is involved in the protection of the lung affected by the COVID-19 by interacting with the SARS-coV-2 entry door: the Angiotensin I Converting Enzyme 2 (ACE2) and the renin-angiotensin system (ras). Elevated systemic levels of apelins and ACE2 activity are associated to less critical forms of COVID-19 and characterized by less pulmonary hyperpermeability and inflammation. Goals: Main: In COVID-19+ patients, to establish the basic knowledge of 1) apelins and related systems (ras and degradation enzymes, of which ACE2) pheno-dynamic profile in bloodstream, 2) pulmonary hyperpermeability profile by biomarker's assessment i) comparison of SARS vs. lesser COVID-19 respiratory injury, and with non COVID-19 ARDS and non ARDS acute respiratory condition. Secondary: To set up links between basic and progressive clinical data (data collection system APEL-COVID).
MedinCell S.A
An early stage trial to check how safe and tolerable, as well as how the body handles continuous daily use of Active IMP over 28 days in healthy volunteers.