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 60 of 1436Acerta Pharma BV
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
Francis Corazza
In patients infected by the SARS-Cov-2 Coronavirus a severely progressive disease requiring hospitalization in intensive care seems related to deregulation of cytokines with very high levels of IL-6, IL-2, IL-7, IL-10 and TNF-α. In order to elucidate the mechanism of this hyper inflammatory syndrome we will measure a panel of pro and anti inflammatory cytokines, as well as known markers of macrophage activation syndrome. To determine the role of activation of the complement cascade the most important complement factors and their activation markers will be measured. The changes of those parameters will be monitored after administration of an anti-IL6R antibody therapy.
Council of Scientific and Industrial Research, India
The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.
University of Colorado, Denver
This study plans to learn more about the effects of a medicine called ruxolitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Ruxolitinib is FDA-approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease. This study intends to define the impact of ruxolitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs. The study will recruit patients who have been diagnosed with COVID-19. The goal is to recruit 80 patients.
Bristol-Myers Squibb
This study is for patients that are hospitalized for Coronavirus Disease 2019 (COVID-19). The purpose of this study is to see whether neutralizing interleukin-8 (IL-8) with BMS-986253 can help improve the health condition of participants infected with COVID-19. This is the first in-human study of this investigational product specifically in patients with severe COVID-19. Currently there are no FDA approved medications that improve the chance of survival in patients diagnosed with COVID-19. However there are usual treatments currently being used to help treat COVID-19 patients and BMS-986253 will be compared to these standard of care treatments in this study.
Centro Investigación Biomédica en Red de Enfermedades Hepáticas Digestivas
Background: Oropharyngeal dysphagia (OD) is a common complication in/post ICU patients that have been with intubation/mechanical ventilation or with tracheotomies or NG tubes, in patients with acute respiratory infection/pneumonia/respiratory insufficiency with a severe disease needing high concentration of oxygen or noninvasive mechanical ventilation and also in patients discharged from acute hospitals to rehabilitation centers, nursing homes or other facilities. All these situations are common for COVID-19 patients that are currently filling our hospitals due to the pandemic expansion of SARS-CoV-2. OD is associated to prolonged hospitalization, dehydration and severe nutritional and respiratory complications -aspiration pneumonia-, hospital readmissions and mortality. Aim: to assess the prevalence of OD and nutritional risk in these patients and to know their needs of compensatory treatment following the application of an early intervention, and to assess whether OD and malnutrition are indicators of poor prognosis for COVID-19 patients. Methods: prospective study in which we will use the volume-viscosity swallowing test (V-VST) to assess the prevalence of OD, and NRS2002 to assess the nutritional risk in admitted patients with confirmed COVID-19 at the Consorci Sanitari del Maresme, Catalonia, Spain. We will register also results of the EAT-10, nutritional status, the needs of compensatory treatments of these patients following an early intervention with fluid and nutritional adaptation and use of nutritional supplements. We will also collect other clinical variables from medical history of the patient related to hospitalization and we will follow the clinical complications and nutritional status at 3 and 6 months follow up.
Pfizer
The purpose of this study is to determine if a CGRP receptor antagonist may potentially blunt the severe inflammatory response at the alveolar level, delaying or reversing the path towards oxygen desaturation, Acute respiratory distress syndrome (ARDS), requirement for supplemental oxygenation, artificial ventilation or death in patients with COVID-19 on supplemental oxygen. * BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.
Azienda Unità Sanitaria Locale Reggio Emilia
The clinical study aims at assessing whether early administration of Tocilizumab compared to late administration of Tocilizumab can reduce the number of patients with COVID-19 pneumonia who require mechanical ventilation. The clinical study includes patients with recent-onset COVID-19 pneumonia who require hospital care, but not invasive or semi-invasive mechanical ventilation procedures.
Centre Chirurgical Marie Lannelongue
Single blind randomized clinical trial designed to evaluate the efficacy of the combination of hydroxychloroquine and dexamethasone as treatment for severe Acute Respiratory Distress Syndrome (ARDS) related to coronavirus disease 19 (COVID-19). We hypothesize that dexamethasone (20 mg for 5 days followed by 10 mg for 5 days) combined with 600 mg per day dose of hydroxychloroquine for 10 days will reduce the 28-day mortality compared to hydroxychloroquine alone in patients with severe ARDS related COVID-19.
Stony Brook University
Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.