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.
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.
To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.Displaying 10 of 60
The purpose of this study is to investigate if a brief online-delivered cognitive-behavioral intervention can reduce the degree of dysfunctional worry related to the Covid-19 pandemic, compared to a wait-list control condition.
The Cleveland Clinic
The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.
Federal University of Rio Grande do Sul
INTRODUCTION In critical situations, such as the current COVID 19 pandemic, themes of fear, uncertainty and stigmatization are common and constitute barriers to appropriate medical and mental health interventions. These challenges, when faced by those who live with a chronic disease, such as diabetes mellitus (DM), can negatively influence quality of life and adherence to treatment, compromising the control of the disease. OBJECTIVES The present study aims to investigate the effectiveness of a tele-intervention during the COVID-19 pandemic in improving glycemic control, lipid profile, blood pressure levels and parameters of medication adherence, mental well-being and sleep quality in patients with type 1 DM and type 2 DM. METHODS A randomized clinical trial will be carried out with patients with a previous diagnosis of type 1 DM and type 2 DM, who are registered at the Hospital de Clínicas de Porto Alegre (HCPA). Inclusion criteria will be age greater than or equal to 18 years, collection of HbA1c in the HCPA laboratory in January, February or March 2020 and availability to receive weekly phone calls. Patients will be randomized, stratified by type of diabetes, in two groups: G1: participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the social distancing period ; G2: participants will receive the usual care. The primary outcome assessed will be the variation in HbA1c levels comparatively between groups, with or without a tele-guided strategy, after four months of social distancing (or as long as the recommendation of social distancing measures remains). Secondary outcomes will include experiencing confirmation of COVID-19 infection, variation in lipid profile, blood pressure levels and variation in parameters of emotional distress related to diabetes, eating disorders, medication adherence, symptoms minor psychiatric disorders and altered sleep patterns, which will be evaluated with specific and validated scales. According to the sample calculation, 150 patients will be included in the study (92 with type 2 DM and 58 with type 1 DM). Analysis by intention to treat will be performed separately for patients with type 1 DM and with type 2 DM. SCHEDULE The proposed experiment will start immediately after approval of this project by the research ethics committee. The duration of the proposed intervention is 4 months (or as long as the recommendation of social distancing measures remains. This means that the study may be completed before or after that period, based on national recommendations for social distancing in Brazil), with a data analysis plan and publication of the results until September 2020.
Hôpital Universitaire Fattouma Bourguiba
A previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our ICU. That has been related to lack of compliance to hand hygiene among health care providers in ou ICU.
Romark Laboratories L.C.
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
University of Utah
Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.
University of Roma La Sapienza
In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge. Given the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an observational, retrospective, non-profit study on the adjuvant use of bacteriotherapy in the early control of disease progression in patients affected by COVID-19 and treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of bacteriotherapy in reducing the clinical impact of acute diarrhea, containing the progression of COVID-19 and preventing the need for hospitalization in intensive care units.
University of California, Los Angeles
The novel coronavirus (COVID-19) is affecting the way many people live their lives, including seeking medical care and maintaining good self-care to keep healthy. Additionally, in the event many people become critically ill at once, COVID-19 has the possibility of overwhelming hospitals to the point where they have to make decisions about how to determine who receives intensive care and life-support measures. Many hospitals as well as local or state governments have been working on policies to determine how to make these decisions. This study seeks to learn about how COVID-19 has affected the way patients and healthcare providers care for themselves and about their thoughts and concerns about policies that may "ration" life-support resources.
Mount Sinai Hospital, Canada, Canadian Institutes of Health Research (CIHR)
Experience from the 2003 Severe Acute Respiratory Syndrome (SARS) outbreak taught that healthcare workers (HCWs) often experience chronic stress effects for months or years after such an event, and that supporting HCWs requires attention to the marathon of occupational stress, not just the sprint of dramatic stressors that occur while infections are dominating the news. This study will test if the well-being of hospital workers facing a novel coronavirus outbreak is improved by adding either of two interventions: (1) Peer Resilience Champions (PRC): an interdisciplinary team of professionals who actively monitor for early signs of heightened stress within clinical teams, liaise between staff and senior management to improve organizational responsiveness, and provide direct support and teaching (under the supervision of experts in resilience, infection control, and professional education). Investigators will test the effectiveness of this PRC Intervention by rolling it out to different parts of the hospital in stages and comparing levels of burnout before and after the intervention reaches particular teams and units (a stepped wedge design). By the end of the study, PRC Support will have been provided to all clinical and research staff and many learners (> 6,000 people). Note that the provision of PRC support will be directed to the entire organization. The research portion of the study is the evaluation of PRC support through a repeated survey completed by consenting staff. Investigators will test the effectiveness of the PRC by measuring trends in burnout and other effects of stress over the course of the study in a subgroup of hospital workers (as many as consent, target ~1000 people) through an online questionnaire (called "How Are You?"). (2) The second intervention is an enriched version of the "How Are You?" Survey, which provides personalized feedback about coping, interpersonal interactions and moral distress. Participants will be randomized (1:1) to receive the shorter Express Survey (identifying data and outcome measures only), or the Enriched survey (all of the Express measures plus additional measures with feedback based on responses). It is hypothesized that both the PRC intervention and the Enriched Survey intervention will help prevent or reduce instances of burnout in HCWs.
This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.