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 270 of 322Liaquat University of Medical & Health Sciences
The purpose of this study is to investigate if Quercetin Phytosome is beneficial for the treatment of COVID-19.
Queen Mary University of London
CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.
Biosearch S.A.
The objective of this trial is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in elderly population living in a nursing home. In addition, it will be evaluated if the probiotic strain have some effect on the immune response generated by the Covid-19 vaccine inthis population.
BRAC University
In line with BRAC's overall goals to limit the COVID19 transmission, BRAC has constructed 1,000 handwashing stations coupled with other supports i.e. in-person demonstration, hygiene meetings, and soap distribution in Bangladesh. The purpose of this study is to assess the impact of public handwashing stations (HWSs) on people's hygiene behavior and health outcomes in response to the COVID-19 situation. For this, at the household level, we will collect information on self-reported handwashing practices, income, health status, and HWSs along with other relevant socio-demographic variables in detail. In addition, we will observe people's mobility, mask usage at public places, and the HWSs usage; and will associate the observed HWSs usage with their self-reported health outcomes. This study will conduct surveys on households (7,760) and public (5,820) in 20 sub-districts of Mymensingh, Khulna, and Dhaka divisions. Overall, this study is expected to directly benefit study participants and their communities by unveiling new evidence to inform BRAC's existing hygiene behavioral change programming in these communities. In addition, this information will yield future societal benefits by generating evidence on how to effectively implement and disseminate infrastructure and information that people can trust, believe, and use to form healthy hygiene habits.
University Hospital Schleswig-Holstein
Based on the literature, it seems likely that a nutritional intervention with nicotinamide (a form of vitamin B3) can support the therapy of SARS-CoV-2 infection (COVID-19). A pilot phase of the COVit trial showed an effect of nicotinamide on the time to complete resolution of COVID-19 symptoms. In addition, diarrhoea is a common symptom of COVID-19. Therefore, in a second part of the study, 420 symptomatic patients each with confirmed SARS-CoV-2 infection are to take 1,000 mg nicotinamide (500 mg conventional nicotinamide and 500 mg nicotinamide released in a controlled manner in the intestine) or corresponding placebos per day in a blinded fashion for 4 weeks. The primary endpoint of the trial is the occurrence of individual COVID-19 symptoms over time (primary analysis time point: week 2). Secondary endpoints focus on the severity of COVID-19 symptoms, the post-COVID-19 syndrome (PCS), anti-SARS-CoV-2 antibody levels, and the time to resolution of individual or all symptoms. Exploratory endpoints include the WHO clinical scale for COVID-19, development of severe COVID-19, fatigue, quality of life and biomarkers. Patients are approached after positive testing and give their informed consent online. After randomised distribution of the trial supplements, patients are interviewed by telephone about their disease course at baseline (week 0), week 2, week 4, week 6 and after 6 months. Stool samples are collected from up to 400 patients at the same timepoints. In addition to blood count and standard blood profile, various inflammatory markers and the metabolome, in particular tryptophan metabolism, are examined in the blood of up to 20 selected patients. In these patients, the viral strain is determined by sequencing from nasopharyngeal swabs. In selected patients, short-term pharmacokinetics of nicotinamide, nicotinic acid and nicotinuric acid as well as of metabolites of nicotinamide and tryptophan are investigated. In the stool, changes in the microbiome (in 100-300 patients) as well as metagenome and metabolome (in a subgroup) will be analysed. The study is expected to produce rapid results on whether nicotinamide supplementation can alleviate the disease course of COVID-19. Moreover, a follow-up interview, a smell test, a cognitive test and anti-SARS-CoV-2 antibody levels after at least 6 months will be used to investigate whether the supplementation has any influence on PCS as well as the immune reaction against SARS-CoV-2.
Germans Trias i Pujol Hospital
A double-blind, placebo-controlled, randomized clinical trial to assess efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19. We want to assess the need for hospital admission for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) infection in outpatients diagnosed of COVID-19 disease, taking a micronutrient supplementation for 14 days. The outcome Will be measured within 1 month after beginning the study treatment. The patients will be followed-up for a period of 180 days.
Hampshire Hospitals NHS Foundation Trust
What are the experiences of staff and participants in phase 3 cardiac rehabilitation during the Covid-19 pandemic, and what impacts have adapted delivery had on participants' physical activity levels, mental health and well-being? Cardiac rehabilitation (CR) is a vital service for individuals diagnosed and treated for cardiovascular disease (e.g., heart attack, angina, valve disease). The service helps to improve recovery rates through supporting patients with beneficial lifestyle changes (e.g., physical activity, healthy eating), and coping with emotional distress following a traumatic cardiac event. The environment in which CR is being delivered has changed in response to the Covid-19 pandemic, including remote working practices, and in some instances postponing of rehabilitation. Despite the public health rationale for such measures, it is essential to consider the impact of adapted services on patient's mental health and physical activity participation, and to consider staff experiences in using remote working regimes. The current study aims to recruit staff and patients from phase 3 cardiac rehabilitation across Hampshire Hospitals Foundation Trust to explore their experiences of adapted services through a mixed methods study design. Staff and patients will be interviewed over the phone to explore experiences and impacts of Covid-19 with their rich in-depth viewpoints and stories. In addition, during an 8 week period of rehabilitation, patients will be asked to report and record their physical activity levels with diaries and accelerometers (a wrist worn device measuring movement), record their resting blood pressure and heart rate, and complete questionnaires to assess changes in mental health. This study could help to understand the impact of the pandemic on cardiac patients recovery and on staff's experiences implementing programme changes to assist in preparing for the future of CR post COVID 19.
Makerere University
The study's purpose is to demonstrate the ability of an mHealth platform as a feasible way of sharing information in a time of restricted movement in order to inform future studies.
Medipol University
In this study; it was aimed to compare the physical activity levels of students who continued their university education face-to-face before the COVID-19 lockdown, and the values of physical activity levels related to health, physical activity levels and health-related physical fitness parameters in the post-lockdown period.
BioGaia AB
This study will explore how a well-known probiotic strain L. reuteri DSM 17938 impacts SARS-CoV-2 specific antibody response upon and after infection in healthy adults.