- About
-
Projects
-
Column 1
- Advancing Regulatory Science
- Animal Health & Veterinary Medicine
- Expanded Access
- FDA Patient Listening Sessions
-
Column 2
- Food & Nutrition
- Improving Access to FDA Information
- Research
- Substance Use Disorders
-
Column 1
- News and Events
- Expanded Access eRequest
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.
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 390 of 530Siew Chien NG
Conditions: COVID19, Microbiota
In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan,wasidentified as the culprit of this disease currently being identified as "CoronavirusDisease 2019" (COVID-19) by World Health Organization.Coronavirus was found to not only target the patient's lungs but also multiple organs.Around 2-33% of Coronavirus Disease-19 patients developed gastrointestinal symptoms.Studies have shown that Severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) wasfound in patient's feces, suggesting that the virus can spread through feces. In ourprevious study, stool samples from 15 patients with COVID-19 were analysed. Depletedsymbionts and gut dysbiosis were noted even after patients were detected negative ofSARS-CoV-2. A series of microbiota were correlated inversely with the disease severityand virus load. Gut microbiota could play a role in modulating host immune response andpotentially influence disease severity and outcomes.The investigators are uncertain about the impact of synbiotic on patients with COVID-19.However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patientswith COVID-9 who take synbiotic or not, leading to lesser progression to severe disease,less hospital stay and improved quality of life.
University of Erlangen-Nürnberg Medical School
Conditions: SARS-COV2
Since the beginning of the year, the entire world has been concerned with the novelSARS-CoV2 virus. After the first case descriptions in Wuhan, there has been a rapidincrease in the number of cases in Germany as well. In case of an illness with the virus,the affected patients can suffer from a slight infection of the upper respiratory tractup to severe lung failure and death. Interestingly, up to now, children are usually lessseverely affected than adults. However, the actual infection rates are probably similarto those of adults, even if the actual prevalence in children is difficult to quantify sofar. The extent of the disease in children has also been less researched to date than inadults, and the same applies to pregnant women and their newborns. In addition, intensiveresearch into possible therapeutic strategies and new vaccines is necessary. Here,however, the number of clinical studies in children is also far behind. In order to beable to understand the infection process and to protect the population with theirchildren, comprehensive testing is necessary. However, this poses great challenges forlocal health authorities. Scientific investigations are also costly, but are alreadybeing carried out by many institutes. So far, for example in the SeBlueCo study, a verylow prevalence of antibodies (1.3% of people) has been show. In children, however, boththe routes of infection and the way the immune system deals with the virus are probablydifferent than in adults. In this study the investigators now want to examine residualblood samples from pediatric patients of the pediatric and adolescent clinic in the timecourse after the beginning of the pandemic in order to better understand and monitor thedevelopment of antibody prevalence.
Imperial College London
Conditions: Coronavirus, COVID19, Pneumonia
The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is atwo-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib(RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatmentof COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patientsprogressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for14 days and will receive follow-up assessment at 7, 14 and 28 days after the first studydose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially,n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis toassess the efficacy and safety of the treatments, approximately n=285 (95 per arm) willbe recruited during Stage 2.
Tourcoing Hospital
Conditions: Virus-HIV, COVID19
The non-essential and non-urgent follow-up consultations of patients living with HIV werepostponed or transformed into "teleconsultation" or exchanges of e-mails betweenpractitioners and patients during COVID-19 epidemic. This change in care can have animpact on follow-up and access to treatment for PVVIH.
ClinAmygate
Conditions: COVID19
Patients reactions towards their diagnosis as having COVID-19. The effect of patients'reaction toward their prospect management. How this can make many hazards. Also, obstacleand barrier to better management.
Hill-Rom
Conditions: COVID-19, Oscillation and Lung Expansion
A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in PatientsHospitalized with COVID-19
Universidade Metodista de Piracicaba
Conditions: Coronavirus Infection
To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitationprotocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to beconducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging andblood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later(T3). Expected results: a) clinical, image and transcriptome changes; b)clinical-functional improvement after CPRP.
University Hospital, Strasbourg, France
Conditions: HIV Infections
North-east area of France was hit in February 2020 by the new coronavirus disease, moreseverely than other French regions. Factors affecting the evolution of the disease andits severity have been quickly identified, among them figuring different kinds of immunedeficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, thosepatients with uncontrolled viral load and/or low CD4 cell counts, remain at higher riskof severe COVID infection. In this context, the primary objective of our study is aimedat evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infectedpatients followed-up in an HIV-infection care center. Secondary objectives are:evaluating whether the antibodies are protective or not, the kinetic of these antibodies,and HIV associated factors with the presence of antibodies.
M.D. Anderson Cancer Center
Conditions: Covid-19 Infection
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus thatcauses the disease COVID-19. This may help to improve testing for COVID-19.
Sykehuset Telemark
Conditions: COVID19
Through SARS-CoV-2 IgG testing of PCR positive and negative cases the study will followthe COVID-19 immune response by monitoring the SARS-CoV-2 IgG antibody levels over aperiod of two years. Further, risk factors will be identified by the use of thetest-negative design including population controls, allowing comparison of participantswith positive and negative tests, and with population controls (triangulation). Specialemphasis will be on high risk groups in general and on different occupational,environmental and socio-economic groups in particular. Finally, severity of illness,deaths and the use of health care during will be assessed using national register datafrom Telemark and Agder.