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 90 of 505West Virginia University
This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
University Hospital, Montpellier
Use lay language. The Covid-19 pandemic hit France in March 2020 and stage 3 of the epidemic justified the introduction of national and unprecedented containment measures from March 17, 2020. The Montpellier CHU experienced peak hospitalizations of Covid-19 infections in late March. The estimate of the proportion of infected people in Occitania, South of France, for the 11th of May 2020 is 3.1% (95% CI: 1.9-5.9) for the Occitania region, to which Montpellier belongs. In the context of the Covid-19 epidemic, notably due to the absence of pharmacological or vaccine prophylaxis, barrier measures were of crucial importance, especially for exposed caregivers. These measures include an adaptation of individual behavior, the creation of a so-called "Covid" hospital, the wearing of specific equipment in all departments, the use in the rooms of Covid-19 patients of a gown, an apron, gloves, and a FFP2 type mask in the event of contact and sampling, protocolized and standardized bio-cleaning measures, a reorganization of the premises and the definition of specific circuits. In view of the second wave of the epidemic, estimating the effectiveness of the barrier measures is of major importance. The investigators therefore propose an evaluation of the effectiveness of these measures, by comparing the serological prevalence of infection among caregivers working directly in COVID units compared to caregivers working in services excluding the management of Covid-19 patients. Systematic evaluation in COVID-19 units of Sarc-Co-V2 infection will also be assessed, with naso-pharyngeal swabs.
Centre Hospitalier Universitaire, Amiens
The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of proinflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation induced thrombosis. Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19. Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.
Żelazna Medical Centre, LLC
The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.
Nevsehir Public Hospital
A rapid oxygen desaturation has observed in patients with COVID-19 which have seriously respiratory failure and most of them have intubated and connected to the mechanical ventilator. Finally, many of them have died during the process. ORF8 and superficial glycoproteins of a novel coronavirus bind to porphyrin on haemoglobin molecules and inhibit heme metabolism in an erythrocyte. However, it is not clarify the effects of the novel coronavirus on mean corpuscular volume (MCV), mean corpuscular of haemoglobin (MCH) and mean corpuscular haemoglobin concentration (MCHC).
Max Healthcare Insititute Limited
The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2 international conveyances. US FDA has recently approved Convalescent Plasma from patients recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections. In a small case series, five critically ill COVID-19 patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the therapy in the second stage.
University of Khartoum
To study the efficacy of Gum Arabic as an immuno modulator and anti-inflammatory agent among COVID 19 seropositive patients..Half of participants will receive Gum Arabic and the other half will receive placebo
University Hospital Southampton NHS Foundation Trust
A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.
San Luigi Gonzaga Hospital
Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients in and/or after the intensive care unit (ICU). Aim of this study is to evaluate the NMES effect on physical function of COVID-19 patients.
University of Edinburgh
ELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home.