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 460 of 753Queen's Medical Center
The overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe COVID-19. The study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching placebo IV. The dose may be repeated in 8-12 hours if clinical symptoms worsens, (e.g. increase in oxygen requirements). Participants will be followed for 28 days.
ATRSS, DGRST, Algeria
By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus disease 2019). This exponential pandemic coronavirus infection is responsible for severe forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%. Algeria was part of the 13 top priority countries identified by WHO based on their direct links and volume of travel to the infected provinces in China. It is known that some predisposing conditions lead to a worse outcome with coronavirus. In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after full adjustment, HR 2.36). The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of patients with diabetes, and (3) to identify the parameters specific to the diabetic which are associated with severe forms. In the future, this study will provide answers for two main questions 1. Why diabetics are more at risk of developing Covid-19 infection? 2. Why diabetics are at high risk of developing severe forms?
Health Science Center of Xi'an Jiaotong University
The COVID-19 pandemic might be an opportunity to review and refine our practices in anti TB treatment. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective. The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the pharmacist and the TB patient. The study was conducted in tertiary care hospital TB control centres patients.
University of Manitoba
As a result of COVID-19 and measures taken by the Canadian Government to reduce the transmission of the virus, in-person psychology services have been suspended. Psychology services are now being conducted via video conferencing. The purpose of the current project is to pilot-test a 6-week Self Compassion Treatment for Chronic Pain delivered virtually, in order to understand its utility in the current environment. The treatment is to be delivered through a secure professional ZOOM licence. Objective 1 of the project is to assess the feasibility and acceptability of attending the treatment group through virtual participation. Objective 2 is to assess the effectiveness of the group treatment in improving self-compassion, mental health, relationship with pain, and quality of life.
Centre Hospitalier Universitaire Dijon
To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%. Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.
Pontificia Universidad Javeriana
Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies, which is related to the decrease in the severity of the clinical picture and suppression of inflammation. This suppression of inflammation may be related to the inhibition of NF-kB polyphenols, where its activation is related to the stimulation of 150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other additional mechanisms that can help control virus-induced respiratory pathologies, among which are the regulation of reactive oxygen species (ROS) associated with tissue destruction caused by the virus and a selective antiviral action can be reported. direct. The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data). These antecedents suggest that the supplementation of patients with COVID-19 with the extract P2Et, could improve their general condition and decrease the inflammatory mediators and the viral load.
Mohammad Sadegh Bagheri Baghdasht
The leading cause of death in patients with COVID19 is a severe inflammatory response caused by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary insufficiency, as well as dysfunction of several vital organs. Therefore, preventing the occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials. Chloroquine and tocilizumab, which have the best results, are also prescribed to control inflammation. But it can be said that treatments are the main source of inflammation. Inflammasome NLRP3 is one of the mechanisms involved in many severe inflammatory disorders. Inflammatory activation has already been demonstrated by many viruses. Melatonin, on the other hand, is a hormone in the body that can inhibit Inflammation NLRP3 in addition to various anti-inflammatory effects, especially after severe inflammation. Older adults with lower levels of melatonin and children with maximum levels of melatonin are the risk groups and low-risk groups for the disease, respectively. In the present study, while measuring melatonin in patients with COVID19, its effectiveness as a treatment method along with the common antiviral drug regimen in patients with severe disease will be evaluated.
Guangzhou Blood Center
The fight against the spread of the 2019-nCoV epidemic has achieved some success in China, but the epidemic is far from over. A key factor making the epidemic under control in China is the government's call for social distance, which has led to few people going out for donation. As a result, the number of blood donors on the streets has been continuing to decline. The first urgent recruitment of blood donors had been implemented during the period from 30 April to 10 May via emergency recruitment SMS . This repeat trial has been designed to further confirm the results from the the first recruitment by comparing which information extraction frameworks would be more sensitive to blood donors in emergency situations.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Medication Overuse Headache (MOH) is a disabling condition that affects the 2% of migraine population. Medication overuse (MO) makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse, but it is also confirmed that patients have to be carefully followed after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. Clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, the regular clinical practice adopted for patients with CM-MO has changed in the last weeks: patients cannot come to the hospital for the withdrawal iv therapy and for regular follow up as the reduced mobility due to the emergency in particular in the Lombardia region, but all over Italy. So the investigators propose a pilot study to enforce the application of a Home-program for the withdrawal procedure for patients and the use of technology like smartphone and video calls so that patients can continue to be followed in their therapeutic process by using behavioral support and mindfulness practice. Patients will perform the withdrawal program at home, by oral administration of therapies, with specific instructions and education. Also the information for behavioral approach and mindfulness practice will be given, to use every day at home. Daily standardized mindfulness sessions of 12 minutes on their smartphone will be combined with weekly video-call to evaluate the clinical condition and to encourage the use strategies for pain management. Face-to-face visits at the follow up every three months will be scheduled. This modality will allow the patients to continue their therapeutic process and to be regularly followed during the one year after withdrawal.
Bharat Biotech International Limited
The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152.