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 160 of 455Institut Pasteur
This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083/V-591).
University of Victoria
The purpose of this study is to evaluate different types of exercise programs (virtual group-based exercise program; personal exercise program; wait-list control) across 12-weeks on the physical and mental health of older adults during the current Covid-19 pandemic.
CSL Behring
This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC) treatment, in patients with Coronavirus disease 2019 (COVID 19)
Stanford University
The purpose of this study is to investigate whether an empirically validated treatment for insomnia (CBT-I) administered early in the course of sleep disturbance can prevent insomnia disorder or lessen negative mental health outcomes in the wake of the COVID-19 crisis in adults.
The University of Hong Kong
This pilot trial aims to evaluate the effectiveness of chat-based instant messaging support in preventing smoking relapse in recent tobacco abstainers.
Direction Centrale du Service de Santé des Armées
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff. A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic. Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool. Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding. The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.
King's College London
Background The immediate psychological impact of COVID-19 is already emerging. The investigators are interested in the benefits of a self-management booklet focused on the current circumstances in response to the COVID-19 pandemic on people's physical and mental wellbeing. Who can participate? The investigators are looking for participants aged 18 and over who live in the UK and can read and write in English, without any current serious mental health problems (e.g. bipolar disorder, PTSD, active thoughts of self-harm, or severe anxiety/depression), and who feel that their physical and/or mental wellbeing have been affected since the COVID-19 pandemic. What does the study involve? Eligible participants will complete questionnaires at baseline following which they will be randomly allocated to either receive the self-management booklet right away (via email) or after 4 months (waiting-list, in the meantime participants will be provided a link to educational materials). Participants will not be able to choose whether they will receive the self-management booklet right away or be in the waiting-list as a computer system (Qualtrics randomiser) will allocate them to one of the two groups at random. Participants in both conditions will be asked to complete online questionnaires at multiple time points, 2-months and 4-months after allocation. Participants in the waiting-list condition will also be asked to complete the same set of questionnaires at 6- and 8-months after allocation to assess how beneficial they found the self-management booklet. Participants will also be invited to take part in an audio-recorded interview after T2 to tell us more about how they found the self-management booklet or the educational materials. The investigators will select 30 participants (15 from each condition) for the interview out of those who opt-in to capture a wide range of experiences and backgrounds. What are the possible benefits and risks of participating? Risks to participants are small. Participants may find reflecting on the impact of COVID-19 on their lives distressing. However, these effects are anticipated to be short lived, as participants will learn psychological techniques during the intervention that can help them manage better in the current circumstances and improve their wellbeing. Where is the study run from? The lead site is King's College London. The study is run online via Qualtrics. When is the study starting and how long is it expected to run for? May 2020 to May 2021 Who is the main contact? Dr Federica Picariello federica.picariello@kcl.ac.uk
University of Copenhagen
The purpose of this study is to investigate whether nicotinamide riboside supplementation can attenuate the severity of SARS-CoV-2 infections in elderly patients. A major event in aging is the loss of the central metabolite nicotinamide adenine dinucleotide (NAD+) that appear to be important in the proinflammatory environment that occur during aging. Notably, recent work from our and other groups suggest that aging can be ameliorated by even a short-term treatment of the NAD+ precursor nicotinamide riboside. Nicotinamide riboside has recently been shown to be able to return aging tissues to a younger state even after short term treatment. This vitamin B3- analog is naturally occurring, is readily taken up through oral administration and has been tested in human trials with few side effects. In this randomized double blinded case-control trial, the investigators will treat elderly (>70 year old) COVID19 patients with 1 g of nicotinamide riboside (NR-E) or placebo for 2 weeks and investigate if this affects the clinical course of the disease.
Biofarma
Scientists and medical workers all around the world were running out of time to manage COVID-19. Several studies have been done to understand the disease and ultimately to find possible treatment. Based on those studies, one of the potential treatment was antibody transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy choice. The rational use of antibody from the patient's plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down. Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients, define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients. The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology. Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan laboratory data will be measured before and after plasma transfusion periodically. The measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and laboratory parameters such as leukocyte count, blood chemical panel include liver and renal function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation. The potential expected risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and transferred foreign pathogen. Investigator will report and treat all adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also report in a special form to sponsor and data safety monitoring board (DSMB). There is theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response. This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future.
Catalysis SL
This is a two-arm, open-label, randomized, phase 2, controlled center study to assess the safety and efficacy of Viusid and Asbrip in patients with mild to moderate symptoms of respiratory disease caused by 2019 coronavirus infection. Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours or standard care. Viusid and Asbrip will be administered orally. A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip plus standard of care and 20 control patients with standard of care. Treatment duration: 21 days.