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 3870 of 4066University of Malaga
The COVID-19 can cause important sequels in the respiratory system by bilateral pneumonia and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Long COVID-19 has been defined as the condition occurring in individuals with a history of probable or confirmed SARS-CoV-2 infection, with related symptoms lasting at least 2 months and not explainable by an alternative diagnosis. The practice of digital physiotherapy presents itself as a promising complementary treatment method to standard physiotherapy, playing a key role in the recovery of function in subjects who have passed the disease and who maintain some symptomatology over time. The aims of this research are to explore the effect of a digital physiotherapy intervention on functional recovery in patients diagnosed with Long COVID-19 and to identify the level of adherence to the treatment carried out. Physiotherapy interventions acquires a fundamental role in the recovery of the functions and the quality of life. As secondary objectives, the aim is to identify the satisfaction and perception of patients with the intervention and the presence of barriers to its implementation (throught a qualitative research), as well as to evaluate the cost-effectiveness from the perspective of the health system. A quasi-experimental pre-post study assessed initially and at the end of the 4-week intervention the functional capacity (1-min STS and SPPB) and the adherence (software). The hypothesis of this research is that the implementation of a TR program presents positive results. If hypothesis is confirmed, that would be an opportunity to define new policies and interventions to address this disease and its consequences.
Emilia Falcone, MD
Sample Size: n=570 Accrual Ceiling: n=627 Study Population: Patients age 18 to 100 years The study duration includes 51 months to recruit patients and 24 months of total follow-up time counted from the first day of COVID-19 symptoms or date of confirmed COVID-19 diagnosis. Study Design: This is a prospective, observational cohort study to evaluate the short- and long-term end-organ complications of COVID-19 and to establish a COVID-19 biobank. Participant Cohorts: 1. Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) 2. Individuals who had previous moderate or severe COVID-19 (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation) 3. Individuals who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis 4. Individuals who have not had COVID-19 (i.e. individuals who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)
Finnish Red Cross Blood Service
This study investigates the possible adverse effects and effectiveness of convalescent plasma for patients infected with SARS-CoV-2. Following provision of informed consent, patients will be randomized into three groups: High-titre convalescent plasma, low-titre convalescent plasma or placebo. Primary outcomes of the study will cover safety and either intubation or initiation of systemic corticosteroids. Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Microbiological and other laboratory parameters will be followed up.
Centre Hospitalier Régional et Universitaire de Brest
COVID-19 is a severe disease with poor prognosis in patients receiving in-center haemodialysis (HD). A population-based registry of >4,000 patients with a diagnosis of COVID-19 receiving kidney replacement therapy (either haemodialysis or kidney transplant recipient) highlighted a 21.1 fold higher 28-day mortality risk among patients on dialysis (n = 3,285), than the expected 1.2% mortality of propensity-score matched historical controls. Vulnerability in uraemic patients is a combination of intrinsic frailty, increased risk of infection and a high burden of comorbidities. In patients on HD, abnormalities in the immune response may contribute to relative hyporesponsiveness to vaccines. However, patients on HD appear to seroconvert at a similar rate compared to the general population after SARS-CoV-2 infection, suggesting a likelihood of vaccine efficacy but this population has been excluded from vaccine trials. The primary aim of this study is to evaluate antibody synthesis induced after Covid-19 vaccination in a French adult multicentric cohort of in-center haemodialysis patients. The second aim of this study is to identify vaccine non-responders among HD patients and to assess the clinical and biological risk factors associated with non-response.
Cardresearch
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in patients with early-onset disease and mild symptoms. Experimental studies have demonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonide and Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggested a reduced complications in patients with COVID-19 disease.
PENTA Foundation
Scientific knowledge about the COVID-19 pandemic and the virus that is causing it (SARS-CoV-2) is developing rapidly, and the investigators have a clearer idea of the population groups who are at higher risk of becoming infected, having serious illness, and dying. However, less is known about COVID-19 in children, adolescents and young adults living with HIV. It is not yet known whether, or how, HIV affects people's risk of being infected with the virus or becoming ill. This study aims to find out whether children and adolescents living with HIV have had the COVID-19 virus, even if they did not have symptoms and did not realise it at the time. When a person is infected with a virus, their immune system fights the infection. As a result, they produce proteins called antibodies, and it may take a few weeks for enough antibodies to be made to be detected by a blood test. These antibodies may help protect the person from getting the same infection again. This study wants to find out how many children and adolescents living with HIV across Europe and South Africa have antibodies to the COVID-19 virus. It wants to see if the proportion with antibodies is different in younger children compared to older adolescents and young adults, and whether it varies between different countries. Children and adolescents with HIV regularly attend hospital outpatient appointments, and during these appointments blood samples may be taken to monitor their health. This study will invite these patients to be tested for antibodies to the COVID-19 virus during their routine visit. The participants will be asked a few short questions about COVID-19 diagnoses in their household and other risk factors for exposure to the virus, and it will collect information on their HIV, medications and any other illnesses they may have. At their next routine clinic visit, approximately 6 months later, it will test them again for antibodies. Testing twice will let see how the percentage of children, adolescents and young adults with antibodies to the COVID-19 virus has changed over time. In South Africa, HIV-uninfected adolescents from a similar socioeconomic background to those living with HIV and recruited to the study will be invited to join this study, which will allow us to compare the prevalence of antibodies across the two groups. The information from this study will help scientists and healthcare workers care for children, adolescents and young adults living with HIV during the ongoing COVID-19 epidemic in the best possible way. Participants may be given their test results, together with information about what the result means, depending on the usual practice within their clinic.
Department of Health and Human Services
This is a prospective single-center study for the follow-up of SARS-CoV-2 positive patients in the district of Konstanz (LKN). As part of the coronavirus pandemic, patients with SARS-CoV-2 infection are currently being treated in the clinics of the LKN's health network at the Singen (Hegau-Bodensee Clinic) and Konstanz (Konstanz Clinic) locations. So far, there is little data on the long-term effects of SARS-CoV-2 infection. As part of this study, the disease progression of these patients will be monitored. Study objective: Prospective, controlled follow-up observation of SARS-CoV-2 positive patients regarding their secondary diseases and quality of life.
Assistance Publique - Hôpitaux de Paris
The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.
Cold Spring Harbor Laboratory
The overall objective of this study is to evaluate the clinical efficacy of oral famotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This study is expected to enroll up to 84 patients with mild to moderate symptoms divided into each of the two study arms. Clinical outcomes of the two treatment arms will be compared. This study will be conducted virtually/remotely.
McGill University Health Centre/Research Institute of the McGill University Health Centre
To evaluate if omalizumab is effective in decreasing mortality in severe hospitalized COVID-19 cases.