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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A coronavirus pandemic began on 12/31/2020 with the first Chinese patient. As of 3/16/2020, the epidemic affects more than 100 countries with 169,000 official infections and 6,500 deaths. This virus causes a pathology ranging from simple flu symptoms in 80% of cases to acute respiratory distress syndromes requiring resuscitation in 5% of cases and a death rate of 1.4 to 4% of cases. The arrival in France on 02/25/2020 with an exponential development of the infection (more than 5,000 cases on 03/15/2020) was accompanied by an unprecedented number of calls to the French emergency service call number (15) of worried patients with overload and sometimes saturation of the service that can impact calls and the care of patients really recovering from an emergency. We previously developed a Moovcare® web application which showed a 7 months survival benefit by early detection of relapsed lung cancer based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 trial randomized. Another application for detecting and monitoring chemo-induced febrile aplasia appears to show a reduction in the number of hospitalizations for sepsis. Finally, Smokecheck, a self-assessment application for symptoms by smokers, has shown that it improves the detection of symptomatic operable bronchial cancers (9 to 24%, p = 0.04). The web application https://www.maladiecoronavirus.fr/ was developed with a group of physicians from the Institut Pasteur, Hospitals group of Paris, Hospitals of Lille and Rennes and the ILC Jean Bernard in Le Mans. It makes it possible to guide symptomatic patients and patients who wishing to know what to do (call their general practitioner, teleconsultation, or call emergency service) based on symptoms and predictive factors of severity. Following the availability of this new tool, we want to assess the impact of the application on the number and relevance of calls to emergency service.
NYU Langone Health
Hyperbaric oxygen therapy (HBOT) treatment will be provided to patients as an adjunct to standard therapy for a cohort of 40 COVID19-positive patients with respiratory distress at NYU Winthrop Hospital. All patients prior to the clinical application of HBOT will be evaluated by the primary care team and hyperbaric physician. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.
Emory University
The objective of this study is to determine the safety, feasibility and efficacy of a bidirectional oxygenation Positive End Expiratory Pressure (PEEP) mouthpiece in coronavirus disease 2019 (COVID-19) patients requiring supplemental oxygen by non-rebreather mask.
Ottawa Hospital Research Institute
The clinical picture of the novel corona virus 2 (SARS-CoV-2) disease (COVID-19) is rapidly evolving. Although infections may be mild, up to 25% of all patients admitted to hospital require admission to the intensive care unit, and as many as 40% will progress to develop severe problems breathing due to the acute respiratory distress syndrome (ARDS). ARDS often requires mechanical ventilation, with a 50% risk of mortality. Researchers at the Ottawa Hospital Research Institute (OHRI) have been studying the potential therapeutic role of mesenchymal stromal/stem cells, or MSCs, for the treatment of ARDS for over a decade. This has led to the world's first clinical trial using MSC therapy for patients with severe infections (sepsis) which is often associated with ARDS (NCT02421484). This trial demonstrated tolerability, and potential signs of efficacy. In addition, the investigators have established expertise in producing clinical-grade MSCs and have received approval from Health Canada for the use of MSCs in three different clinical studies. This protocol consists of 2 sequential trials using the same trial infrastructure, noted as the Phase 1 trial 'CIRCA-1901' and the Phase 2a trial 'CIRCA-1902'. CIRCA-1901 is an open-label, dose-escalating and safety trial using a 3+3+3 design to determine the safety, and maximum feasible tolerated dose of repeated delivery of Umbilical Cord Mesenchymal Stromal Cells (UC-MSC) intravenously. The investigators will enroll up to 9 patients; each receiving repeated unit doses of UC-MSCs delivered by IV infusion on each of 3 consecutive days (24±4 hours apart) according to the following dose-escalation schedule (3 patients per dose panel): (i) Panel 1: 25 million cells/unit dose (cumulative dose: 75 million MSCs), (ii) Panel 2: 50 million cells/unit dose (cumulative dose: 150 million MSCs), (iii) Panel 3: up to 90 million cells/unit dose (cumulative dose: up to 270 million MSCs). If no safety issues are identified, we will continue to the Phase 2a trial. CIRCA-1902 is a single-arm, open-label extension of the CIRCA-1901 trial to assess early signs of efficacy (major morbidity and mortality). The Phase 2a trial (CIRCA-1902) will enroll 12 patients to assess early signals of benefit on mortality and major morbidity in a high risk, high mortality population.
Derince Training and Research Hospital
The aim of this study is to compare the impact of using the aerosol box and transparent sheet as an adjunct to conventional personal protective equipment on endotracheal intubation of COVID-19 patients. The effect of the head of the bed elevation will also be evaluated during the mentioned simulated scenarios.
Stéphane Cook, Prof
During the last couple of years, a growing number of wearable devices evolved to provide accurate, cheap and non-invasive monitoring of vitals parameters.This connected care technology could be helpful for treatment and care during a pandemic such as COVID-19. The use of these non-invasive remote monitoring devices can help health care providers to assess patient's vital signs and symptom progression, reducing reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic.
University of Milano Bicocca
Prospective, observational, multicenter study aiming to evaluate the number of COVID-19 pneumonia related patients treated with non-invasive ventilatory support outside the intensive care unit. In addition, the study aims to obtain information related to the clinical characteristics and hospital results of these patients.
Belarusian State Medical University
Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Egyptian Center for Research and Regenerative Medicine
The medical and paramedical staff of the front-line services are potentially exposed to SARS-CoV-2. Therefore, despite the application of standard protective measures, it is possible that a certain number of these personnel have already contracted SARS-CoV-2, including in its asymptomatic form. Serological testing in this context would be useful for deploying immune healthcare workers as to limit the risk of viral infection and transmission. Therefore, it is of utmost importance to prove that the serological response entails the production of neutralizing antibodies.
Priscilla Hsue, MD
The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.