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 80 of 148The Hospital for Sick Children
Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) have dramatically impacted the lives of children/adolescents (children) and families. The closure of schools, social and recreational activities, and modifications to work environments 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 families has not been well researched, it is anticipated that already stressed children and families with pre-COVID-19 mental health challenges are at significant risk for deterioration in their mental health. As such, the implementation, and evaluation (specifically: feasibility, acceptability and barriers) of virtual-care interventions to alleviate child and family anxiety and enhance family functioning are critical. Virtual-care also optimizes health equity initiatives in reducing social, economic and environmental 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 in treating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, and Chorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting the efficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr, and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate the feasibility, participation barriers related to social determinants of health (SDH) and acceptability of this virtual-care intervention in addressing mental health challenges associated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Early evaluation of this virtual-care intervention will enable future scale-up of this intervention during the post-pandemic recovery time-period and during subsequent COVID-19 waves, if necessary.
University of Alberta
A novel coronavirus disease 2019 (COVID-19) outbreak is a global dramatic pandemic that is immeasurably impacting the communities. Due to lack of data, symptomatic management is used for COVID-19 infection including oxygen therapy and mechanical ventilation for those with severe infection. Considering immunomodulatory, anti-inflammatory anti-fibrotic and anti-oxidant actions of vitamin D, it's safety and ease of administration, as well as direct effects of vitamin D on immune cell proliferation and activity, pulmonary ACE2 expression and reducing surface tension, evaluation of vitamin D supplementation as an adjuvant therapeutic intervention could be of substantial clinical and economic significance. High prevalence of vitamin D deficiency in elderly, smokers, patients with chronic diseases and excess uptake by adipose tissue in obesity make investigations of its role as a secondary therapeutic agent in COVID-19 conceivable. It should be necessary to monitor serum 25(OH)D levels in all inpatient and outpatient populations with COVID-19 to identify the importance of maintaining or promptly increasing circulating levels of 25(OH)D into the optimal range of 100-150 nmol/L. The aim of this study is to conduct a double blind, randomized, controlled three weeks clinical trial on the efficacy of vitamin D (daily low dose versus weekly high dose) in COVID-19 patients in order to determine the relationship between baseline vitamin D deficiency and clinical characteristics and to asses patients' response to vitamin D supplementation in week three and determine its association with disease progression and recovery. Subjects who are randomized to high-dose will be asked to take 50,000 IU for two times during the first week and one dose over second and third weeks to quickly raise their serum levels. Subjects in the low-dose arm will take vitamin D 1000 IU daily for three weeks.
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 second 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.
October University for Modern Sciences and Arts
effect of proper diet and vitamins on the oral health and the regeneration of the taste and smell in Covid 19 patients
Al-Azhar University
Covid-19 is an emerging critical highly infectious virus
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.
Massachusetts General Hospital
Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings is a research study aimed at developing, implementing, and evaluating a package of interventions specifically designed to reduce COVID-19 and other infectious-disease incidence, hospitalizations, and mortality among staff and adults with Serious Mental Illness and Intellectual and Developmental Disabilities in congregate-living settings.
AGIR à Dom
Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19. This hypothesis is supported by numerous preclinical and theoretical arguments, as well as by some Chinese clinical studies (the Chinese guidelines for the management of Covid-19 recommend the inhalation of hydrogen), a recommendation whose interest has just been confirmed by a publication describing the very positive results of a clinical study in China. Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19. The ingestion of water saturated with molecular hydrogen has been the subject of several clinical studies in other indications than Covid-19, and no side effects of this ingestion have been reported. A recent publication recommends initiating clinical trials using a hydrogen fortified beverage.
Derince Training and Research Hospital
It should be known by the clinician that COVID-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems.
Baylor College of Medicine
COVID-19 is associated with increased mortality, and has been linked to a 'cytokine inflammatory storm'. Populations at higher risk of COVID complications and mortality include the elderly, diabetic patients and immunocompromised patients (such as HIV), and the investigators have studied these 3 populations over the past 20 years and have found that they all have deficiency of the endogenous antioxidant protein glutathione (GSH), elevated oxidative stress, inflammation, impaired mitochondrial function, immune dysfunction, and endothelial dysfunction. It is known and established that GSH adequacy is necessary for neutralizing harmful oxidative stress, and that elevated oxidative stress appears to promote mitochondrial dysfunction. The combination of oxidative stress and mitochondrial dysfunction have also been linked to inflammation, immune dysfunction, and endothelial dysfunction. In prior studies in aging, the investigators have also identified that supplementing glutathione precursor amino-acids glycine and cysteine (provided as N-acetylcysteine) improves GSH deficiency and mitochondrial function, and lowers oxidative stress, inflammation, and endothelial dysfunction. The investigators have coined the term GlyNAC to refer to the combination of glycine and N-acetylcysteine. This study will evaluate the prevalence and extent of these defects in patients with COVID-19 admitted to the hospital, and the response to supplementing GlyNAC or placebo for 2-weeks. Because patients with COVID-19 are also being reported to have fatigue and cognitive impairment, the investigators will also measure fatigue and cognition at admission, 1-week and 2-weeks after beginning supplementation. The supplementation is stopped after completing 2-weeks, and these outcomes will be measured again after 4-weeks and 8-weeks after stopping supplementation.