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 710 of 1496Université de Montréal
Background: Traditionally, medical students learn surgical skills through the observation of a resident or a surgeon performing the technique. Due to inconsistent practice opportunities in the clinical setting, a disparity of skill levels among students has been observed. In addition, the poor availability of faculty professors is a limiting factor in teaching and adequately preparing medical students for clerkship years. With the ongoing COVID-19 pandemic, medical students do not have access to traditional suturing learning opportunities. Didactic courses are available on videoconferencing platforms, but they do not include technical training. Objective: Our overarching goal is to evaluate the efficacy of web-based peer-learning for advanced suturing techniques (i.e., running subcuticular sutures). The investigators will use GEN (Gamified Educational Network), a newly developed online learning tool. The investigators will assess students' ability to identify and to perform the right technique. The investigators will also assess students' satisfaction with regards to GEN. Methods: The investigators will conduct a prospective randomized controlled trial with blinding of expert examiners. First-year medical students in the Faculty of Medicine of Université de Montréal will be randomized to four groups: 1) control group, 2) self-learning, 3) peer-learning, and 4) peer-learning with expert feedback. Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN. For our primary outcome, students' ability to identify the right technique will be evaluated before and after the intervention on GEN. They will view eight videos and rate the surgical technique using the OSATS (Objective Structured Assessment of Technical Skills) Global Rating Scale (GRS) and the Subcuticular Suture Checklist as evaluation criteria. For our secondary outcomes, students will anonymously record themselves performing a running subcuticular suture and will be evaluated using the same scales. Then, a survey will be sent to analyze the overall performance of the platform. Results: The study will be conducted in accordance with the Declaration of Helsinki and has been approved by our institutional review board (CERSES 20-068-D). No participants have been recruited yet. Conclusions: Peer-learning through GEN has the potential to overcome significant limitations related to the pandemic and the lack of availability of faculty professors. Further, a decrease of the anxiety related to traditional suturing classes can be expected. The investigators aim to create an innovative and sustainable method of teaching surgical skills to improve the efficiency and the quality of surgical training in medical faculties. With the current world events of COVID-19, the necessity for such tools are imperative.
Centre for Addiction and Mental Health
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Lawson Health Research Institute
Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.
University of the Balearic Islands
The main objective of the study will be to evaluate the effectiveness of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week Mindfulness-based cognitive therapy (MBCT) program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. We will collect patient data using the questionnaires administered at baseline, immediately after the intervention, and at six and 12-month follow-up. The primary outcome will be depression severity and secondary outcomes will include health-related quality of life.
Centre Hospitalier Universitaire de la Réunion
Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic has spread around the world. The people most exposed to this virus remain the healthcare personnel who are on the front line in the fight against this pandemic. Due to the delayed nature of the pandemic in Reunion island and its insular geographical situation, the study of the voluntary medical personnel will allow the investigators to establish a longitudinal follow-up of the anomalies of the lipidic balance in relation to the exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profiles are profoundly modified with very significant reductions in plasma cholesterol levels, LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles are altered during viral infections, for example, the severity of dengue is inversely correlated with total cholesterol and LDL-C but not with HDL-C levels, according to a recent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteins rich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptor class B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the dengue virus and increase its infectivity by promoting its entry into cells, also via SRB1. At the moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. The investigator hypothesize that a drop in plasma HDL-C levels and a change in their size during infection could justify future therapeutic approaches aimed at supplementing the subjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosa pneumonia in mice, investigators have shown that the injection of reconstituted HDL allowed to limit the pulmonary inflammation and the deleterious consequences of the infection. The investigator propose to study not only the lipid profiles in subjects who are infected with SARS-CoV-2 but also the polymorphisms of genes involved in the regulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP) depending on the developed forms, symptomatic or not.
Mansoura University
We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy
Hospital Sultanah Bahiyah
The Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The case-control study is described here (the cross-sectional study is described in a separate ClinicalTrials.gov record).
University of Birmingham
CovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic. Centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. During the pilot study, investigators should enrol patients with confirmed diagnoses of: - Colorectal cancer - Oesophagogastric cancer As a rapid response study to the COVID-19 pandemic, included cancer types will evolve throughout the course of the CovidSurg-Cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.
University of Catanzaro
Passive immunotherapy through plasma infusion of convalescent subjects - convalescent plasma - or "hyperimmune" plasma was one of the most widespread and effective anti-infective treatments in the pre-antibiotic era and one of the founding pillars of immunology, and has also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which there were no alternative immunoprophylactic or therapeutic interventions. To date, there are not proven etiological therapies for SARS-CoV-2 infection, the agent responsible for the disease called Covid-19. Among those subjected to clinical studies during the current epidemic in China, hyperimmune plasma appears to be one of the most rational and promising. The objective of this study will be to evaluate the efficacy and safety of the hyperimmune plasma administered add-on to the anti-Covid-19 treatment (standard therapy) according to clinical practice in patients with severe Covid-19 infection, compared to patients with severe Covid-19 infection treated only with standard therapy.
University Hospital, Toulouse
The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viral pneumopathy that can progress to acute respiratory distress syndrome (ARDS). The host-pathogen relationships and the physiopathological mechanisms underlying the clinical aggravation of COVID-19 patients remain misunderstood. The project aim is to create a prospective cohort of biological samples collected from well characterized COVID-19 patients. This project aims first to identify based on these samples an early immune signature predictive of clinical worsening of COVID-19 patients in order to improve their management, and secondarily to better understand pathophysiological mechanisms underlying the different phases of the disease in order to identify innovative therapeutic targets and vaccine perspectives.