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 410 of 1330Hôpital Necker-Enfants Malades
The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology.
DILEK SAYIK
The coronavirus outbreak has adversely affected individuals in the community, as in the rest of the world. However, in order to carry out this epidemic period in a healthy and conscious manner, determining the anxiety levels of individuals in the society and supporting them psychologically is of great importance. In order to achieve this, healthcare professionals working clinically or academically have important duties. This study was planned to test its validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.
Brigham and Women's Hospital
Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of an oral formulation of cyclosporine, Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no Neoral + SOC. The primary endpoint is disease severity based on the World Health Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include safety and changes in serum inflammatory markers.
Northwestern University
To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.
Ministry of Health, Brazil
This is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected SARS-CoV-2 infection. The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients. A secondary goal is to identify biological factors (OMICS - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.
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.
Assiut University
Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed
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.
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
Arcturus Therapeutics, Inc.
Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers.