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 20 of 77I-site University Lille North Europe
No optimal antiviral intervention has been yet validated to treat COVID-19 disease. Comorbidities, such as older age, obesity, diabetes, history of cardiovascular diseases are associated with poor prognosis. This study aims to evaluate the efficacy of two experimental antiviral treatments, compared to standard of care (SOC), to prevent clinical worsening, hospitalization or death at day 14 in adults with documented SARS-CoV-2 infection, asymptomatic or with symptoms lasting less than 8 days, and associated comorbidities without any severity criteria of the disease at inclusion. Participants will be randomized to receive SOC alone or SOC + hydroxychloroquine 200 mg three times a day during 10 days or SOC + association of niclosamide 2 g at J1 then 500 mg two times a day with diltiazem 60 mg three times a day during 10 days. Efficacy and tolerance of each treatments will be compared across the three treatment groups during the 28 days of follow-up.
Assistance Publique - Hôpitaux de Paris
Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak immunosuppressive effect, is prescribed by some teams alone or in combination with azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in primary care in the early stages of the disease. However, currently available data suggest better efficacy if treatment is given early in the disease, before symptoms worsen. To date, the majority of COVID-19 patients treated in outpatient care, particularly in general practice, represent the majority of COVID-19 patients. It is essential to evaluate, in primary care, the efficacy and safety of hydroxychloroquine combined with azithromycin in Covid-19 patients in order to be able to implement this therapeutic strategy as soon as the first symptoms appear. We realize a randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).The main objective is to assess the efficacy of Hydroxychloroquine combined with azithromycin in COVID-19 patients in primary care, in add-on to standard of care, on unfavorable outcome defined by the onset of at least one of the following between D0 and D14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air.
Memorial Sloan Kettering Cancer Center
This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.
Fondation Lenval
The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children. Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children
Hospital St. Joseph, Marseille, France
Up to date, and since December 31st 2019, 2 520 522 cases of COVID-19 including 176 786 deaths, have been reported worldwide. Global efforts are made to save lives and decrease morbidity by evaluating therapeutic strategies. Pregnant women with COVID-19 are at high-risk of severe complications and mortality from COVID-19 infection, due to physiologic and immune changes occurring during pregnancy. These risks include development of maternal hypoxemic respiratory failure due to severe pneumonia, hospitalization in intensive care, death; but also, fetal morbidity-mortality with chronic and/or acute fetal distress, intrauterine growth retardation, intrauterine death and neonatal morbidity, mainly due to induced preterm birth and maternal-fetal transmission. Knowledge of these epidemiologic facts on SARS-Cov-2 infection in pregnant women is currently limited to small case-series. No drug has demonstrated solid evidence in treating SARS-Cov-2 virus. Nevertheless, in vitro studies and tests in COVID-19 positive patients treated with hydroxychloroquine and azithromycin merit further evaluation. Pregnant women are systematically excluded from drug trials, and treatment options for this high-risk population remain untested. The aim of this study is to screen pregnant women presenting minor symptoms, for COVID-19 and to evaluate efficacy of hydroxychloroquine-azithromycin treatment in preventing aggravation of symptoms with development of hypoxemic respiratory failure and complications of pregnancy.
Louisiana State University Health Sciences Center in New Orleans
Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory infection, emerging data show that morbidity and mortality are driven by disseminated intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing multiple systems organ failure and consuming enormous healthcare resources. Identifying strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates. The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis. The purpose of the proposed multi-center, prospective, randomized controlled trial is to test the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can mitigate the prothrombotic state and reduce hospitalization rates.
University of Manchester
A team at the University of Manchester are developing a test that tcould be helpful in detecting immunity to the Coronavirus (which causes the COVID-19 disease) in participants with inflammatory arthritis. It is based on a flu assay has already developed; the team will replace the flu antigen with a Coronavirus antigen to see if it is effective. This project aims to develop a test to see if people who have had the virus have developed immunity to it. This could help to predict who might or might not get the disease a second time, who should stay at home to be protected from potential infection or who will not develop any symptoms, even if exposed to the virus. When vaccination trials against the Coronavirus will be launched, this test could also help to see if the vaccine is effective.
University Hospital Tuebingen
Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: Until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers
Lawson Health Research Institute
The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). In addition, one arm will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care) and act as a control group. The second group will receive an essential oil retraining kit, whereas the third group will receive the same olfactory training kit and a prescription to use budesonide with the nasal irrigations. Olfactory scores will be tested at the enrollment, 3 months and at 6 months.
Aarhus University Hospital
The purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms