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 520 of 643Ministry 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.
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.
Hospital Sao Rafael
The COVID-19 pandemic is of grave concern due its impact on human health and on the economy. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, anti-oxidant properties, and various aspects of the SARS-CoV-2 infection mechanism are potential targets for propolis compounds. Propolis components have inhibitory effects on the ACE2, TMPRSS2 and PAK1 signaling pathways; in addition, antiviral activity has been proven in vitro and in vivo. This is a pilot randomized study that aims to assess the impact of using Brazilian green propolis extract against the deleterious effects of the new coronavirus.
Kaleido Biosciences
This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.
Antonio Secchi
Evaluate SARS-CoV2 infection and the degree of immunity possibly developed in transplanted population using the Luciferase Immuno Precipitation System (LIPS) test.
HealthQuilt
Assess the impact of a proprietary extract of Nerium oleander on immune function as evidenced by COVID-19 symptoms and mortality in COVID-19 positive patients and their close contacts compared to controls that did not receive the extract.
Universidad Miguel Hernandez de Elche
The pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to alleviate emotional overload, acute stress reactions and other affective pathologies or psychosomatic reactions that may eventually lead to post-traumatic stress situations. This eventuality is being observed massively among professionals from different groups and levels of responsibility. In the case of healthcare personnel, it should be added that the care of non-COVID19 patients (of all pathologies and conditions) is clearly compromised and it is up to the professionals as a whole to make critical decisions and exercise a professional practice that is radically different from what has usually been done, which may require the application of undesirable triage criteria that are difficult for everyone to assume. Healthcare professionals and other essential personnel for healthcare and social-healthcare work (including personnel from external companies) are being subjected to emotional tensions and extraordinary, high-intensity work demands. Without professionals who feel supported and with moral strength, care will be even more compromised. The current scenario makes us think of many critical situations that are occurring as a result of the overload experienced. It is essential to act in order to counteract the devastating effect of this health crisis on health professionals and those who support them in their care work.