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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Displaying 70 of 370Centre Hospitalier de Cayenne
Multicenter observational study of diagnostic test validation (Research Involving theHuman Person, type 3) In addition to the diagnosis by the reference method(nasopharyngeal swab), the patient will be asked to provide a saliva sample via asalivary spit. The clinical circumstances of the diagnosis, the age of the patient, theassociated terrain (diabetes, immunodepression, pregnancy) will be noted. Thenasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining sampleswill be frozen and stored at the CRB before being sent to the University Hospital of Caenfor analysis and concordance verification.The expected benefits are:Possibility of repeating tests in the same person more easily due to the absence of painand thus reduce the barriers to diagnosis and screening.Possibility of self-sampling, which could simply be sent to the laboratory, which wouldrelieve the diagnostic sites that mobilize staff and require a fairly heavy organization.Avoid long waiting lines that can be an obstacle and lead to a renunciation of thediagnosis.
Centre Hospitalier Universitaire de Nīmes
The investigators wish to set up a pharmaco-epidemiological cohort within the HospitalTerritorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and WestTarn on a specific population, patients undergoing immunotherapy for cancer, as currentlythere is no data available under "real life" conditions following anti-COVIDvaccination19. The hypothesis is that patients undergoing immunotherapy will not developmore vaccine-related adverse events than those observed in the efficacy and safetyvalidation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2,Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.
Beijing 302 Hospital
This is a phase III randomized, double blinded, placebo-controlled multi-center study toassess the efficacy and safety of aerosolized Novaferon for the treatment of asymptomaticor mildly patients infected with SARS-CoV-2.
Michal Chudzik
Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results frominfection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 isnot only a short-term infection. Patients (pts) recovering from SARS-COV2 infectioncomplain of persisting symptoms including: fatigue, diffuse myalgia and weakness, whichmay lead to chronic fatigue syndrome and as well as many other complications.The vast majority of COVID-19 patients remaining in isolation/quarantine, due to the mildcourse of the disease, do not require hospitalization. In this group of patients, thecourse of COVID-19 is very different - from asymptomatic patients to very severe and longlasting symptoms also with a decrease in saturation.There are many studies describing the course and complications of patients hospitalizeddue to COVID-19. There is little published data on how non-hospitalized patients get sickand what are the early and late complications of SARS-CoV-2 infection. In addition, manypatients remain ill even many months after COVID-19, entering what is known asLONG-COVID.Therefore, the STOP-COVID Registry was established. The purpose of the Registry is toassess the course of COVID-19 infection, early and late cardiovascular complications ofCOVID-19 in patients with and without hospitalization. In addition, the purpose of theSTOP-COVID Registry is to assess the incidence of LONG-COVID with all other complicationsand to identify predictive factors.
Ministry of Health, Thailand
The purpose of this study is to examine the effect of Andrographis Extract, BoesenbergiaExtract compared to standard treatment in asymptomatic COVID patients.
Azienda Sanitaria-Universitaria Integrata di Udine
Hypoxemic acute respiratory failure is one of the main COVID-19 patients complicationthat lead to in intensive care hospitalization.This complication determines a variable mortality from 25 to 30%. To correct hypoxemia(often severe) is often needed non-invasive or invasive mechanical ventilation.Mechanical ventilation is not a therapeutic strategy, but it allows to extend thetime-to-recovery necessary to solve COVID-19 respiratory failure cause.Calibration of ventilatory support is essential to ensure adequate time-to-recoverywithout contributing to onset lung and / or diaphragmatic damage.Basal diaphragmatic activity assessment, device for administering the oxygenation supportchoice and setting ventilatory support parameters are decisive.Ultrasound is the best method for measuring diaphragmatic work. The aim of this study isto evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted toIntensive Care Unit (ICU) for acute respiratory failure and to record its function onweaning.
National Institute of Allergy and Infectious Diseases (NIAID)
Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknownto date. It has been reported that coronaviruses cause direct central nervous systeminfection (Needham et al. 2020). Besides that, new or worsening cognitive impairmentcommonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey &Needham. 2020). The purpose of our study is to search and describe the cognitive andpsychiatric long-term consequences of COVID-19 on patients who have been discharged fromcritical care units. This is an ambidirectional cohort study, that attempts to followadults discharged from critical Care Units Adults due to COVID-19 up to 12 months afterdischarge, to evaluate the presence of cognitive impairment, linguistic and phonationfunction, depression, fatigue, functional gastroenterological symptoms, anxiety, or posttraumatic disorder, and performance in activities of daily living and physical responseto exercise as well.
University of Arizona
Viruses are a major health problem for the general public and at risk populations.Normally, detection of antibody titers is the gold standard for determining theeffectiveness of the immune system following natural or vaccine caused immunization.However, determining the effectiveness of other parts of the immune system are lesscommon due to the difficulties with testing. Furthermore, there is a critical need toaddress other therapies in case vaccination is not successful in immuncompromisedpopulations. Exercise has been shown to increase the strength of the immune systemagainst many types of viruses and therefore could be simple way to improve immunityagainst the COVID-19 virus. The aim of this research is to determine the effects ofexercise on anti-viral immunity against many types of common viruses before and aftervaccination. We hypothesize that exercise will enhance the anti-viral immunity before andafter vaccination.Up to 30 healthy volunteers (age 18-44 years) will be recruited to participate in thisstudy. For completion of Aim 1, three visits are needed totaling around 7 hours of thepatient's time and for Aim 2, three visits are needed totaling around 4.5 hours of thepatient's time. The initial visit will be for pre-screening and if deemed healthy enoughto participate, an exercise test to determine the VO2 max of the participant will beconducted. The following visits will require a trained phlebotomist to insert anin-dwelling catheter and participants will undergo a 20-minute incremental exercisetrial. Approximately 50mL of blood will be collected at four different timepoints: atrest, 60% VO2 max, 80% VO2 max, and 1-hr post-exercise. All four collected blood sampleswill be used to expand viral specific T-cells and compare IFN-γ rele
Ohio University
The coronavirus (COVID-19) pandemic is a significant psychological stressor thatthreatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19and its economic impact, as well as loneliness due to the required social isolation, aredriving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll,45% of respondents reported that the coronavirus has had a negative impact on theirmental health. This is reflected in Southeastern Ohio. In data that the investigatorscollected from 317 Ohio University faculty, staff, and students from late May to earlyJune, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severelevels of depression and 57% reported the COVID-19 outbreak was impacting their sense ofsocial connection much or very much. Despite the significant community need foraccessible and affordable care, there are currently no evidence-based interventions forindividuals coping poorly with coronavirus-related distress. The investigators havedeveloped a virtual group-based intervention targeting cognitive biases that amplify theexperience of stress and anxiety (i.e., amplifying cognitions; Coping withCoronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing thisintervention in a scientifically rigorous manner is to refine the manual and proceduresand conduct a pilot test of the intervention.
Samia Hassan El-Shishtawy
Evaluation of the efficacy of the AstrazenicaCovid 19 vaccine to develop IgG antibody andits level based on th12 weeks program. Also to follow the changes of markers ofcoagulation (D-dimer) after vaccination compared to the basic level. A cardiologyconsultant will follow D-Dimer results to be managed properly if there is a need. As itis expected to receive Sinopharm vaccine there will be comparison between results of thetwo types of vaccine. To our knowledge this will be the first study done on Egyptianpopulation.