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 20 of 303Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria. So, our hypotheses are: 1. Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19? 2. the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?
The Christ Hospital
The investigatores propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease as reflected by the presence of elevated hsTPN. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illness. Investigators hypothesize that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality and a key secondary objective to reduce the requirement for and/or duration of mechanical ventilation. Finally, as the hospital mortality for patients requiring mechanical ventilation is very high (50 to 80%), these patients will be eligible for COVID19 CP treatment as well, even in the absence of elevated hsTPN. Although considerable overlap of these populations has been observed (elevated hsTPN and requirement for mechanical ventilation) there is not 100% redundancy and it is hopeful that COVID19 CP may provide benefit to these critically ill patients.
Universidad de Antioquia
Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses. Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them. For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.
Assistance Publique - Hôpitaux de Paris
There is very little data so far to determine whether people living with HIV (PLWHIV) are at greater risk of COVID-19 acquisition or severe disease. HIV infection is associated with deficiencies in both humoral and cell-mediated immunity that could potentially alter the course and severity of common infections. The investigators will study the correlation between clinical and immunovirological data. The singularity of this work is to have an in-depth immunovirological approach linked to the clinical characteristics in COVID-19 HIV co-infected patients. COVIDHIV is the only study to date to offer this combined approach in PLWHIV. This protocol is a historical and prospective cohort study of PLWHIV presenting COVID-19 The primary objectives are to describe the course of COVID-19 disease in patients infected with HIV
National Cancer Institute (NCI)
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
University of Pittsburgh
Since the novel coronavirus, SARS-CoV-2, was first reported in the Hubei province of China in December 2019, the US has become an epicenter for the pandemic, accounting for more than 220,000 cases and 4,800 deaths (CDC). The rapid spread of the associated disease, COVID-19, has overwhelmed healthcare systems in spite of unprecedented measures to reduce contagion. The resulting uncertainty with regard to the duration and magnitude of the pandemic and limited availability of resources and treatment have been detrimental to the mental health of frontline healthcare providers (NIH). Preserving the psychological wellbeing of these individuals is paramount to mitigating the effect of COVID-19 and delivering optimal patient care. Of particularly grave concern is how professional and personal distress caused by the COVID-19 pandemic will affect provider burnout (Lai et al. JAMA Network Open 2020). Professional burnout, characterized by emotional exhaustion, career de-prioritization, and loss of self-efficacy, represents a significant threat to the US healthcare system (Shanafelt et al. Ann Surg 2010; Han et al. Annals of Internal Medicine 2019). While burnout has been described as a reaction to chronic work-related stress (Melamed et al. Psychol. Bull. 2006), individual factors such as anxiety increase susceptibility to burnout (Sun et al. J Occup Health 2012). Although data suggests that occupational stress might amplify risk of anxiety (DiGiacomo and Adamson J Allied Health 2001), we have yet to understand how intensified anxiety among frontline providers during global health crises contributes to burnout. Similarly, it is unknown whether factors such as perceived organizational support (POS), a key driver of job satisfaction and performance (Muse and Stamper, J Managerial Issues 2007), modify anxiety and burnout under these circumstances. We hypothesize that diminished POS in response to the COVID-19 pandemic is associated with burnout and that this relationship is mediated by an increase in providers' anxiety. Delineating this relationship is a critical first step in developing interventions that ease the mental health burden of this pandemic and future crises for healthcare providers.
Acibadem University
According to the data of February 2020, in Turkey with a population of 83.9 million, internet and social media usage percentage to population are 74% and 64% respectively. Although previous researches have investigated the effect of social media on different medical situations, there is no study focused role of social media on patients' behavior and information source during the COVID-19 pandemic. In the present study, it is aimed to reveal the impact of social media on patients' attitudes and information sources during the COVID-19 pandemic.
Sultan Qaboos University
Background: COVID-19 (Corona Virus Disease 2019) is a virulent infectious disease with an incubation period ranging between 2-14 days. This highly contagious disease is caused by Sars-Cov-2 (Severe Acute Respiratory Syndrome Coronavirus 2). The number of people infected by COVID-19 has increased exponentially since January as a result of traveling and contact with COVID-19 infected individual. Initially, the seriousness of COVID-19 was not gauged properly until World Health Organization classified it as Pandemic type infectious disease and rapidly made plans actions to fight against it on 20 January, 2020. The uncertainty and low predictability of COVID-19 not only threaten people's physical health, but also affect people's mental health, especially in terms of emotions and cognition. As consequence of public emergency, with its economic health and social impacts, psychological repercussions among people are inevitable at the short and long term. Importance and justify the study: This study will assess the effectiveness of e therapy in treating anxiety and depression during a pandemic. This would be a novel way of providing therapy during crises Hypothesis: We hypothesize that compared to self-help email delivered therapy, the therapist guided e-Therapy is more efficacious in reducing the level of psychosocial stress among distressed individuals in Oman during COVID19. Objective: The aim of this study is to assess the efficacy of six weeks therapist guided e-Therapy versus Self-help e-mail delivered therapy on Psychological distress among random sample of individuals live in Oman during COVID 19 pandemic. This study will recruit 60 participants from a list respondents to public survey who reported high levels of depression and anxiety, and randomize them to either therapist guided e-psychotherapy(intervention) or (control) self-help arms. Participants in the intervention arm will receive six sessions of therapist guided e therapy as described in the study schedule. Participants in the control arm will receive self-help psychotherapy contents similar to the intervention arm as detailed in the study schedule. Throughout the study, outcome and safety assessments will be conducted.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Low-dose radiotherapy treatment delivered to both lungs in patients with immune-related pneumonia following COVID-19 infection is backed up by biological and clinical bases that justify its use as a possible therapeutic option in these patients. This is a preliminary exploratory study (non-pharmacological interventional) to evaluate the feasibility and tolerability of low-dose radiotherapy treatment of SARS-Cov-2 immune-mediated pneumonia, for the subsequent implementation of a phase II study.This is a preliminary, monocentric, single-arm, interventional, non-pharmacological exploratory study. All enrolled patients will be treated with low-dose radiotherapy. Participants will undergo irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy (further details in the dedicated section).