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.
Search Tips
To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 290 of 2879Mario Negri Institute for Pharmacological Research
Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care. Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.
Philipps University Marburg Medical Center
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 severe pneumonia.
Centre Hospitalier Universitaire de Nīmes
For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed
University Hospital, Strasbourg, France
In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.
Vanderbilt University Medical Center
This study aims to determine if provider-recommended guidance on supine (on back) vs. prone (on stomach) positioning of patients testing positive for COVID-19 requiring supplemental oxygen, but not yet mechanically ventilated, improves outcomes in the inpatient setting. This study will be performed as a pragmatic clinical trial.
National Cancer Institute (NCI)
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
University Medical Center Groningen
Rationale: The investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients. Objective: The main objective is to assess whether genetic background and/or the nasal epithelial gene expression in response to SARS-CoV2 is different in patients with mild, severe or very severe disease. The secondary goal of this study is to investigate a) the role of the ACE2-AngII system during SARS-CoV2 in relation to outcome b) the long-term consequences of mild, severe, and very severe COVID-19 infection c) the association between mild, severe and very severe COVID-19 with clinical & molecular markers of disease progression d) whether the faeces microbiome, virome or metabolomics profile predicts clinical outcome in COVID-19 patients and e) to investigate whether pre-existing antibodies towards other coronaviruses play a role in severe disease development. Study design: Prospective open label clinical observational study. In this study samples will be collected from 150 COVI-19 patients ( 50 mild (group 1), 50 severe (group 2) and 50 very severe (group 3) ). Blood, nasal brushes and stool will be collected for all groups at hospital admission and 3 months after recovery, and for groups 2 & 3 at day 3, at day 14, and before detubation Study population: A total of 150 patients diagnosed with COVID-19 will be included. The investigators aim for 50 patients per group, divided over 3 groups: Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization. Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care. Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation. Main study parameters/endpoints: The primary endpoint of this study is the identification of genes, pathways and cell populations that associate with clinical outcome and disease progression in mild, severe and very severe COVID-19 patients.
National Institutes of Health Clinical Center (CC)
Background: The Coronavirus disease 2019 (COVID-19) pandemic is a major public health issue. Researchers want to collect plasma from people who have recovered from COVID-19, and use this plasma to treat people who are sick with the disease. The plasma will have antibodies against the virus that causes COVID-19. Persons who have received a COVID-19 vaccine may also donate plasma that contains antibodies against the virus if they meet criteria according to the FDA. Objective: To collect plasma from people who have recovered from COVID-19 or have been vaccinated against the coronavirus that causes COVID-19, so that the plasma can be used to treat people with the disease. Eligibility: Adults ages 18 and older who have been diagnosed with, and have recovered from, COVID-19. Design: Participants will be screened with a physical exam, medical history, and blood sample. Their pulse, blood pressure, and temperature will be taken. Their height and weight will be recorded. Participants will donate plasma. It will be collected through whole blood donation or through apheresis. For whole blood donation, a needle will be placed in the participant s arm vein. Blood will be withdrawn. For apheresis, a needle will be placed in the participant s arm vein. Blood will be withdrawn. A machine will separate the plasma from the red cells. The plasma will be removed, and the rest of the cells will be returned to the participant either through the same needle or through a needle in their other arm. Participants will have 3 to 20 plasma donations. Participation will last up to 3 years.
Nakhle Saba, MD
I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in 1. intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT. 2. hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19. II. Study Population: 1. Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older. 2. Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness. III. Study Agent: SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL at neutralization antibody titer >1:160.
Shahid Beheshti University of Medical Sciences
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .