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 320 of 1381Massachusetts General Hospital
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.
Mayo Clinic
This expanded access program will provide access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
Tourcoing Hospital
Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated. We propose to compare to the Gold-Standard defined above, the combination of an SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.
University of Jena
RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.
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.
Sanotize Research and Development corp.
This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.
Rutgers, The State University of New Jersey
This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.
University Hospital, Lille
Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.
Novartis is the Marketing Authorization Holder for Jakavi outside the US.
The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with severe/very severe COVID-19 illness. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication. Please refer to the latest Investigator's Brochure (IB) or approved label for overview of ruxolitinib including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.
University Hospital, Montpellier
Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit. Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings. We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).