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 390 of 427University of Ottawa
In March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19 since testing began. For many of these patients, symptoms resolve within 4 weeks of onset. However, it is becoming apparent that a significant number of individuals are experiencing symptoms that persist long after the acute infection, known as Long COVID. These individuals have a wide constellation of presenting symptoms, often varying from initial presentation. For this study, we will be enrolling individuals receiving care at The Ottawa Hospital for Long COVID. This study aims to determine the following four things: 1) will adding electronic case management improve quality of life three months after coming to hospital with Long COVID; 2) is the electronic case management platform cost effective; 3) is there any factors that predict outcomes at 3 months; 4) to determine how a personalized rehabilitation program supported by a digital platform could be implemented for individuals with Long COVID. We will enroll individuals from The Ottawa Hospital who will then be randomly assigned to receive either usual care or usual care plus electronic case management, through a platform called NexJ Connected Wellness. Participants will also complete questionnaires every 4 weeks for 3 months. We will be looking at quality of life, mental and physical health, cognitive symptoms, fatigue and pain.
Fondation Hôpital Saint-Joseph
SARS-CoV2 is responsible for a pandemic that has been evolving for approximately 18 months. The virus' capacity for dissemination and its virulence are responsible for significant morbidity and mortality. The initial lack of knowledge of the pathogen and of the pathophysiology underlying the potential severity of the disease, particularly in the respiratory tract, led to numerous therapeutic attempts in this emergency context, centered on the control of an obviously exaggerated inflammatory response. A large number of studies remained of insufficient quality to lead to relevant and applicable conclusions. Secondly, the benefit of corticosteroid therapy has been demonstrated in two trials. Although Dexamethasone remains the only corticosteroid to improve survival, these results have reinforced the hypothesis of the interest of treatments reducing the inflammatory response, particularly cytokine. The widespread use, in the absence of scientific data, of interleukin-6 receptor inhibitors (Sarilumab and Tocilizumab) has been structured around studies whose results remain uncertain to this day because of the heterogeneity of the population treated and the results observed. A possible survival benefit seems to emerge for resuscitation patients who have not yet required invasive ventilation, the other situations being probably associated with the absence of effect or even the potential danger of this treatment. Tocilizumab is notably associated in the literature with the risk of secondary infections and mucosal healing abnormalities, favoring bleeding complications and digestive perforations. The objective of this study is to evaluate the risk of digestive complications (hemorrhage, perforation, diverticulitis) and infectious complications related to the use of Tocilizumab according to the severity of the patients.
Instituto Brasileiro de Osteopatia
Background: Fatigue is among the most common symptoms of the long-term effects of coronavirus (long COVID). This study aims to compare the effectiveness of osteopathic manipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PT alone on fatigue and functional limitations after two months post randomization in adults with long COVID. Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomized controlled superiority trial. Seventy-six participants will be randomly allocated to OMT+PT or PT. The PT includes usual care interventions including motor and respiratory exercises targeting cardiorespiratory and skeletal muscle functions. The OMT entails direct, indirect, visceral, and cranial techniques. Patients will be evaluated before and after a 2-month intervention program, and at 3-month follow-up session. Primary objectives comprise fatigue and functional limitations at 2-month post randomization as assessed by the fatigue severity scale and the Post-COVID Functional State scale. Secondary objectives comprise fatigue and functional limitations at 3 months, and the perceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).
Pregistry
The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.
A. Vogel AG
Respiratory viruses pose a permanent threat to humans and society as demonstrated by the current Covid-19 pandemic. Novel drugs and vaccines provide a means for controlling illness. Infections and symptomatic presentation of illness may be reduced, but it remains to be determined to which extent viral shedding and transmission (e.g. by silent transmitters) can be controlled. Lack of such activity may result in continuing viral spread by assumed healthy but asymptomatic spreaders. Echinacea is an established and readily-accessible product with demonstrated in vitro antiviral activity (including coronaviruses). This study aims to estimate the potential of different Echinacea formulations (head-to-head) to reduce concentration infectivity and shedding of SARS-CoV-2 under in vivo conditions.
Hemex Health
Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.
Columbia University
The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.
Università Vita-Salute San Raffaele
Collection and analysis of demographic, clinical, radiographic and laboratory characteristics of CoViD-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions
Centre Hospitalier Intercommunal Creteil
In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan, Hubei Province in the People's Republic of China. The disease spreads rapidly and the number of sick people is increasing. On January 3, 2020 a new virus of the coronavirus family is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhan and subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the World Health Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On 11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus 2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is a pandemic. As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with more than 16,000 deaths attributed to this virus. (Ref WHO https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ). In France, the number of cases rose from 105 cases at the end of February to 19615 confirmed cases on March 24. (Source Public Health France). Most of the cases are adults. However, children are not completely spared and serious cases have been described. These severe cases can be respiratory or extra-respiratory (e.g. myocarditis). We also know that pediatric and adult cases differ in terms of clinical, biological and imaging findings, particularly chest CT scans. However, the description of paediatric pictures, especially severe forms and the involvement of children suffering from co-morbidities, remains poorly reported. Finally, the risk factors for serious cases in children remain largely unknown. This observatory aim to describe the clinical phenotypes of hospitalized pediatric patients with Covid19 in France, according to age groups. Moreover for a subgroup of patients, informations regarding the long covid will be reported.