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 280 of 370King's College London
The Covid-19 viral pandemic has caused significant global losses and disruption to allaspects of society. One of the major difficulties in controlling the spread of thiscoronavirus has been the delayed and mild (or lack of) presentation of symptoms ininfected individuals, and the insufficient Covid-19 testing capacity in the UK. Thiswarrants the development of alternative diagnostic tools that reliably assess Covid-19infection in the early stages of infection, while also being low- cost, low-burden, andeasily administered to a wide proportion of the population.This study aims to validate machine learning models as a diagnostic tool that predictsinfection with SARS-CoV-2 based on app-reported symptoms and phenotypic data, against the'gold-standard' swab PCR-test. This study will take place within the Covid Symptom Studyapp, the free symptom tracking mobile application launched in March 2020.
King's College Hospital NHS Trust
COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients whichrequire intensive care unit admission. In critically ill patients infected with COVID-19,approximately 15% had severe shock requiring medications to increase blood pressure. Itappears that blood vessel tone is altered and microcirculation is not well regulated inpatients with COVID-19. The underlying pathophysiology and contributing factors areunknown. The association with subsequent organ dysfunction and outcome is also unclear.Therefore, the investigators aim to investigate serial changes of relevant biomarkers inthis population to improve the understanding of this disease, to investigate theassociation with clinically important outcomes and to find out how best to treatpatients. The data will serve to develop strategies for individualised management of thishigh-risk group.
Guy's and St Thomas' NHS Foundation Trust
This study aims to find out whether the use of angiotensin II, which is a drug to raiseblood pressure has been approved by European Medical Agency in August 2019, as an add-onmedication to increase blood pressure in patients with COVID-19, acute severe lunginjury, inflammation and severe shock, compared with standard medication. In addition,the investigators will collect the data of Anakinra, another drug which is frequentlyused in this condition to reduce inflammation.The investigators will collect clinical data and outcomes from critical care patients.The investigators will analyse for whom these drugs are most beneficial and explorewhether there are any patients who don't benefit or have side effects.
University Hospital Muenster
This research aims to investigate the role of daily measurement of urinary cell cyclearrest markers and other serum and urinary biomarkers to predict the development of acutekidney injury in critically ill patients with COVID-19 and acute respiratory disease.
Vastra Gotaland Region
COVID-19 is a global major public health emergency that disproportionately affectspatients with risk factors such as advanced age, heart and lung disease, diabetes,hypertension, as well as compromised immunity. Despite the recent worldwide emergence ofthis disease and its rapid progression to a pandemic, very little is known about therisks facing solid organ recipients. The study aims to elucidate the prevalence ofsymptomatic, subclinical, and asymptomatic infection in the transplanted population byassessing their immunological response to SARS-CoV-2 infection. This will be studiedseroepidemiologically in the whole cohort and retrospectively in transplanted patientsadmitted to hospital for COVID-19.Primary objective: to elucidate the cumulative prevalence of SARS-CoV-2 infection in thetransplanted population related to symptoms and hospitalizations; to assess the magnitudeof immunological response and seroconversion kinetics for COVID-19. Secondary objectives:To examine the influence of medical parameters on COVID-19 infection and immune responsesuch as: age, comorbidities current and recent pharmacological treatment, organtransplanted, and blood type, HLA genotype.Study design:Part 1: Longitudinal cohort study for seroepidemiology and disease burden. Part 2:Retrospective case-series for seroconversion kinetics and clinical course assessment.Study population:All solid organ transplanted patients in Sweden
The Hospital for Sick Children
Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) havedramatically impacted the lives of children/adolescents (children) and families. Theclosure of schools, social and recreational activities, and modifications to workenvironments has led to significant changes in the way children and families are working,living and socializing. Although the impact on the mental health of children and familieshas not been well researched, it is anticipated that already stressed children andfamilies with pre-COVID-19 mental health challenges are at significant risk fordeterioration in their mental health. As such, the implementation, and evaluation(specifically: feasibility, acceptability and barriers) of virtual-care interventions toalleviate child and family anxiety and enhance family functioning are critical.Virtual-care also optimizes health equity initiatives in reducing social, economic andenvironmental barriers to services that can improve or maintain mental health (WHO, 2017;MOHLTC, 2018).The current study will evaluate an adapted virtual-care cognitive behavioural therapy(CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base intreating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, andChorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting theefficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr,and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate thefeasibility, participation barriers related to social determinants of health (SDH) andacceptability of this virtual-care intervention in addressing mental health challengesassociated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Earlyevaluation of this virtual-care intervention will enable future scale-up of thisintervention during the post-pandemic recovery time-period and during subsequent COVID-19waves, if necessary.
University Hospital, Grenoble
The current project is a prospective, multicentric cohort study aiming at amultidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of theconsequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to bettercharacterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2will be included in the study 3 months after their diagnosis: They will be followed at 6months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3months and their evolution.
University of Glasgow
One-in-four patients with COVID-19 pneumonia develop life-threatening heart problems.Through cardiovascular imaging and biomarkers analyses this study aims to evaluatewhether COVID-19 infection results in heart injury. The investigators will alsoinvestigate which patients are at risk of heart injury as a result of COVID-19 and whyonly some patients suffer heart problems as a consequence of the infection. The studywill also assess multisystem involvement including the lungs and kidneys.
University of Toronto
The Açaí trial will be testing if the açaí berry extract, a safe natural product withanti-inflammatory properties, can be used as a treatment option in adult patients withCOVID-19 in the community.
Boston Children's Hospital
This is a randomized double-blind placebo-controlled Phase II trial of recombinant humandeoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients withCOVID-19 pneumonia.Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanicalventilation will be invited to participate in this study. Potential subjects will beidentified from medical record review or from direct contact with physicians.Investigators will check medical history and confirm eligibility. Informed consent willbe obtained from either the patient or designated healthcare proxy.60 subjects will be enrolled. After obtaining informed consent, patients will berandomized 2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longerreceiving mechanical ventilation, whichever is sooner plus standard of care vs. placebonormal saline 2.5 ml plus standard of care.