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 410 of 1572Novartis is the Marketing Authorization Holder for Jakavi outside the US.
The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with severe/very severe COVID-19 illness. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication. Please refer to the latest Investigator's Brochure (IB) or approved label for overview of ruxolitinib including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.
Assiut University
A pneumonia of unknown cause detected in Wuhan, China was first reported to the WHO Country Office in China on 31 December 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. The spread and severity of the disease is variable from one country to another. Our team as well as many reports suggested that in some countries a " Flu like illness but much worse" was described in October, November and early in December before the WHO announcement. Was it COVID-19?
Assistance Publique Hopitaux De Marseille
The aim of the study is to demonstrate overactivation of Renin Angiotensine System (RAS) in positives COVID-19 patient, especially in those with the most serious clinical forms where the mortality of patients in intensive care is on average 50%. We are expecting two groups: a group of 25 positive COVID 19 patients in intensive care and a group of 25 positive COVID 19 hospitalized patients in conventional hospitalisation. We will measure RAS, serum potassium and collect data on the treatment of these patients (especially antihypertensive therapy) one week apart (at the patient'entry into hospital and 7 days later). This is a preliminary study that could possibly allow the start of a therapeutic trial in order to test the effectiveness of RAS blocker treatments in this condition.
Royal National Orthopaedic Hospital NHS Trust
Magnetic Expansion Control (MAGEC) growth rods are used in the surgical treatment of children with scoliosis; the primary constituent metal alloy in these is titanium. Since June 2019, the manufacturer has released two Urgent Field Safety Notices (FSN) relating to known issues with the function of the rods that increase the risk of early failure and unplanned revisions. The UK MHRA has issued two similar Medical Device Alerts (MDA) with the most recent MDA issued on 1st April 2020, stating that (1) MAGEC rods must not be implanted in the UK until further notice and (2) all patients already implanted with this device should be followed up as soon as is possible. At the time of writing, hospitals across the world are facing incredible challenges in dealing with the COVID-19 pandemic. Due to this, virtually all planned clinic visits for MAGEC rod patients and X-ray appointments have been postponed to help reduce the risk of the virus spreading. Recent retrieval studies have shown that mechanical wear and corrosion of these rods is common, with a risk that the debris generated is released into surrounding tissue. This wear and corrosion is thought to be the primary cause of implant failures and the underlying implant factors leading to the issuing of FSNs and MDAs. Whilst titanium is known to be highly biocompatible, the baseline and toxic levels of this alloy in biological fluids are poorly understood. Additionally, a better understanding of blood titanium levels in patients with MAGEC rods may enable this to become a biomarker of wear and corrosion of the rods. This may help surgeons identify earlier those patients who may develop implant related problems. Furthermore, in the current COVID-19 environment, a blood test to measure titanium levels may be one of the most suitable ways in which to continue patient monitoring (and identify those at greatest risk of implant related issues), in the absence of regular clinic visits. Previous work from the RNOH involved a similar study investigating patients with titanium hip implants.
Guy's & St Thomas NHS Foundation Trust
The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.
Intermountain Health Care, Inc.
This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.
Memorial Hermann Health System
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen responsible for the novel coronavirus disease 2019 (COVID-19). The first reports of COVID-19 came from Wuhan, China in December of 2019. Since then, the disease has spread rapidly around the globe, accounting for thousands of deaths in multiple countries. On March 11th, 2020, the World Health Organization declared COVID-19 as a pandemic. Although COVID-19 manifests primarily as a respiratory illness, several cardiovascular implications have been reported related to its natural course and treatment. Its exact effect on the cardiovascular system though is currently unknown. Therefore, we propose a retrospective, observational, case-control study looking for cardiovascular manifestations of COVID-19, including laboratory evidence of myocardial injury, electrocardiographic changes, arrhythmias and echocardiographic abnormalities. Hospitalized patients admitted with fever, cough, sore throat, and/or dyspnea who were tested positive for SARS-CoV-2 will be included in our study and will be matched based on their age and gender with patients admitted with similar symptoms who tested negative for SARS-CoV-2. The electronic medical charts of the study subjects will be reviewed and relevant demographic, clinical, laboratory and imaging findings will be deidentified and recorded. Since our study will be a retrospective chart review study it carries minimal risk for the patients and the investigators. Cardiovascular disease associated with COVID-19 might be contributing to the high mortality rates and its recognition will allow for prevention, early diagnosis and appropriate treatment. This will be the first, large, case-control study assessing cardiovascular involvement of COVID-19 in a well-defined cohort of patients.
Peking University First Hospital
To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
Centre Hospitalier Universitaire de Nice
Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.
Fonds Erasme pour la Recherche Médicale
Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.