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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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 160 of 732Columbia University
Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.
Mayo Clinic
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
Poitiers University Hospital
All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health. To evaluate the diagnostic performance of chest CT in screening for COVID-related lung injury in patients with a clinical suspicion of COVID. CT scan results for COVID according to French thoracic imaging society will be dichotomized into evocative or compatible (considered positive) non-evocative (considered negative) The results will be compared to the gold standard corresponding to a multiparametric element: the discharge summary. Ct Scan performance will be recorded and analyzed.
Puren Hospital Affiliated to Wuhan University of Science and Technology
The COVID-19 pneumonia has grown to be a global public health emergency since patients were first detected in Wuhan, China, in December 2019, which spread quickly to worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 pneumonia. Hence, there is a large unmet need for a safe and effective treatment for COVID-19 pneumonia patients, especially the critically ill cases. The significant clinical outcome and well tolerance was observed by the adoptive transfer of allogenic MSCs. We proposed that the adoptive transfer therapy of MSCs might be an ideal choice to be used. We expect to provide new options for the treatment of critically ill COVID-19 pneumonia patients and contribute to improving the quality of life of critically ill patients.
University of Colorado, Denver
The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing unnecessary exposures to the virus. Results from real-time PCR tests to detect active COVID-19 infections may not be available in a timely fashion during emergent trauma assessments. Since the start of the COVID-19 pandemic, a rapidly expanding body of literature has identified a pattern of imaged lung abnormalities with CT and ultrasound (US) characteristic of an active viral infection. US evaluation provides a reliable, portable, and reproducible way of evaluating acute patients in a real time setting. During initial trauma evaluations, patients may also receive adjunct imaging modalities like the Focused Assessment with Sonography in Trauma (FAST) exam designed to discover life threatening findings that may require urgent interventions. We therefore propose a study expanding on the current FAST adjunct evaluation in the trauma bay that may include lung parenchyma imaging at the initial assessment to help stratify patients into low or high-risk groups for active COVID-19 infections. We believe the use of point of care US in the initial assessment of the trauma patient may help identify potentially infected individuals and aid ED providers to best directing subsequent laboratory and imaging evaluations for these patients, while further directing the necessary protective measures for additional team members involved in the care of the injured patient.
Instituto Grifols, S.A.
The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
National Taiwan University Hospital
In the ER of National Taiwan University Hospital, the critical patients are treated (including tracheal intubation and cardiopulmonary resuscitation) in either resuscitation area or negative pressure isolation rooms based on the past history and present illness. During COVID-19 epidemic, whether sequential changes in environmental and personal protective equipment would change the difference of treatment efficacy and patient safety remains unclear. Whether treating patients in resuscitation area or negative pressure isolation room would cause different physical and psychological stress of medical staff and environmental contamination is also unknown. This study aims to conduct a prospective sequential allocation clinical trial to investigate the success rate, patient safety, physical and psychological stress of medical staff, and the risk of environmental contamination of tracheal intubation and cardiopulmonary resuscitation between the resuscitation area and negative pressure isolation room. The results of the study may be used to improve the protocol and protective policy in treating critical patients during an epidemic.
Sinocelltech Ltd.
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
Grifols Therapeutics LLC
The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
Fundacion Infant
Trial design. Randomized, double-blind, placebo-controlled trial in a catchment population of 2,020,860 age-appropriate subjects in the state of Buenos Aires and 235,000 in the city of Buenos Aires. Institutions. Hospitals San Juan de Dios, Simplemente Evita, Dr. Carlos Bocalandro, Evita Pueblo, Sanatorio Antartida, Hospital Central de San Isidro, Clinica Olivos in the state of Buenos Aires with 38 regional and town hospitals acting as referral centers, and Hospital Militar Central, Sanatorio de Los Arcos, Hospital Universitario CEMIC, Sanatorio Sagrado Corazon, Sanatorio Finochietto, Sanatorio Anchorena, Centro Gallego, and in the city of Buenos Aires in Argentina. Study population. Subjects >= 75 years of age irrespective of presenting comorbidities or between 65-74 years of age with at least one comorbidity (hypertension, diabetes, obesity, chronic renal failure, and COPD) who experience the following signs and symptoms for less than 48 hours at the time of screening for SARS CoV2 by RT-PCR: (a) a temperature >=37.5°C and/or unexplained sweating and/or chills and (b) at least one of the following: dry cough, dyspnea, fatigue, myalgia, anorexia, sore throat, loss of taste and/or smell, rhinorrhea. Subjects consenting to screening will be tested by reverse-transcriptase-polymerase-chain-reaction (RT-PCR) for SARS-CoV-2 in a nasopharyngeal and an oropharyngeal swab and invited to participate when RNA for the virus is detected. Intervention. Eligible, consenting patients will be randomized using an electronic system to receive 250 ml of convalescent plasma with an IgG titer against SARS-CoV2 spike (S) protein >1:1,000 (COVIDAR IgG, Insituto Leloir, Argentina) or placebo (normal saline 0.9%) administered in a 1:1 ratio. Both treatment and placebo will be concealed using dark bags and tape to cover the infusion line. Treatment will be administered 30 and/or an O2 sat