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 1290 of 1422Wladimir Szpirt
This Randomized Control Trial (RCT) proposes combination of extracorporeal cytokine removal by plasma exchange (PLEX) and additional infusion of convalescent plasma (CCP) collected from COVID-19 recovered individuals at the end of the PLEX procedure. The combination of cytokine removal by PLEX and CCP infusion is in onvestigators opinion more rational compared to CCP infusion alone and as such probably more effective in reducing the duration of mechanical ventilation, length of stay in the intensive care unit, and potentially also mortality.
Fondazione Don Carlo Gnocchi Onlus
Worldwide, the COVID-19 pandemic continues to grow. Although COVID-19 mainly affects the lungs and internal organs, musculoskeletal injury from this disease was reported with the presentation of marked elevation in creatine kinase and lactate dehydrogenase levels. Patients with post-acute COVID-19 are considered patients with a post-intensive syndrome (PICS) that results in loss of functional independence. In the physical and rehabilitation medical field, various modalities with therapeutic exercise can be used to manage pain by a physical therapist and psychiatrist. Pain management is particularly important during the COVID-19 pandemic because of the reduced accessibility to hospitals and medical resources.
Evangelismos Hospital
Although management of acute hypoxemic respiratory failure associated with coronavirus disease 2019 (COVID-19) often includes mechanical ventilation, the optimal timing of initiation of invasive mechanical ventilation remains unknown. We hypothesise that a randomized controlled trial comparing early intubation as opposed to delayed intubation among patients with COVID-19 suffering from severe acute hypoxemic respiratory failure is feasible.
Henry M. Jackson Foundation for the Advancement of Military Medicine
The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed. Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection. This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers. A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.
Istituto Ortopedico Galeazzi
It is becoming increasingly evident that sleep plays an essential role for human health, and it represents an important biophysiological variable for athletes' well-being and recovery. The International Olympic Committee recently highlighted the importance of obtaining sufficient sleep volume and quality among athletes, but acute sleep deprivation is not unusual. Several factors, both endogenous and exogenous, are able to negatively influence sleep in athletes: body temperature, altitude, chronotype, training volume, anxiety, westward and eastward travels, and many others. Since December 2019, when a new coronavirus (SARS-CoV-2) was originally revealed by an ophthalmologist in Wuhan (Hubei province, China), a related severe acute respiratory syndrome - namely COVID-19 - has been spreading at a pandemic rate, putting global health systems under unprecedent pressure. Italy, as the first Western country tremendously hit by this disease outbreak, has become the iconic resilient outpost under international policymakers' attention. When initial clusters were identified, restrictive actions to curb isolated upsurges of infection were taken by the health region system of Lombardy, thereafter, were extended to all northern Italy and to the entire country. From February 21, when the first Italian COVID-19 case was diagnosed in southern Lombardy, to March 22, when Italian's government restrictions to contain the pandemic were extended, prohibiting all non-essential business activities and banning all movements of people nationwide, the country faced an unchartered scenario, from several standpoints, along with the psychosocial one. Inevitably, the Covid-19 outbreak has largely influenced the daily life of athletes too. Therefore, the primary aim of this study was to examine the differences in athletes' sleep quality, quantity and training volumes during the social confinement due to the virus outbreak. For this purpose, a survey will be used. This variables will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.
Hospital de Clinicas de Porto Alegre
A pragmatic superiority randomized controlled trial comparing Telepsychoeducation plus personalized videos vs. Telepsychoeducation without personalized videos for the prevention of future emotional distress in professionals and students from essential services with low to moderate levels of emotional distress in Brazil. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.
Assiut University
To study the effect of getting Covid-19 infection during pregnancy on the outcomes of the mother and the fetus including morbidity and mortality
praxisgemeinschaft für zelltherapie
Currently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C. In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.
Universitas Padjadjaran
This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Rhea Health Tone® as add-on therapy in hospitalized adults with COVID-19. The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any change would be accompanied by updated sample size. Subjects will be assessed while hospitalized. All subjects will undergo a series of laboratory (inflammatory biomarkers (IL-6, hs-CRP, IFNγ), SGOT, SGPT and Creatinine, conversion rate by PCR, QTc prolongation by ECG, chest X-ray), clinical (clinical assessment, vital sign, concomitant medication, other medical conditions) and safety assessment (serious adverse event). Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2 = SoC + Rhea Health Tone®.
Vanderbilt University Medical Center
To assess the co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva, and to determine duration of COVID-19 activity in ocular fluid and saliva by serial tests over 3 months.