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 1320 of 1534Merck Sharp & Dohme LLC
The primary objective of this study is to evaluate the safety and tolerability of V590 versus placebo and to assess the immunogenicity of V590 on Day 28. The primary hypothesis is that at least one well-tolerated dose of V590 increases the geometric mean titers (GMTs) of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike serum neutralizing antibody, as measured by plaque reduction neutralization test (PRNT), compared to placebo.
Biosurf LLC.
The purpose of this study is to prove the efficacy and safety Surfactant-BL, administered by inhalation in adult hospitalized patients with ARDS due to COVID-19.
Brain & Spine Institute (ICM)
Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.
Ospedale Andrea Tortora di Pagani
It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment. Particular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection
Siyan Clinical Corporation
The primary objective of this survey study is to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. Data collected may serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19. This survey study will utilize the Epidemic-Pandemic Impacts Inventory (EPII). This is a newly tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains.
Paradigm Laboratories LLC
Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.
Enzychem Lifesciences Corporation
A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19
Medical University of Warsaw
The study will be conducted in the UCKWUM teaching hospital in Warsaw between 2020 and 2022. The study group will be comprised of UCKWUM healthcare professionals All employees willing to participate in the study will receive an anonymous questionnaire on attitudes towards influenza vaccination . We will distribute information posters of the National Programme for Combating Influenza as part of the educational programme. In order to increase the effectiveness of the educational campaign, we will also send information e-mails, using the internal hospital e-mail system and conduct a series of online training courses to present the latest international reports on influenza vaccinations among health care professionals [CITATION Abr10 \l 1045]. Considering the fact that lack of time [CITATION Kus11 \l 1045] is the most common reason for not getting vaccinated against influenza among healthcare professionals, we will provide this group with an opportunity to receive free influenza vaccination during working hours at the UCKWUM hospital. Information about the possibility of vaccination will be provided in the form of e-mails (mailings) to hospital employees (internal hospital e-mail system), letters of information submitted to the offices of individual departments, and information posters. The effectiveness of the educational programme will be assessed by re-administering the anonymous questionnaires after the influenza season, also by means of internal hospital e-mail system.
Children's Hospital Medical Center, Cincinnati
As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. As new residents and fellows arrive in July 2020 to Cincinnati Children's Hospital Medical Center (CCHMC), many of whom come from metropolitan areas across the country, it is imperative that investigators determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. The investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection among trainees at CCHMC, including risk factors for transmission and immunological recovery. SCREEN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection within the cohort of CCHMC residents and fellows who have patient contact. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), the investigators will determine the prevalence and cumulative incidence of infection by SARS-CoV-2; the investigators will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.
University of the Philippines
This protocol provides access to investigational convalescent plasma for hospitalized patients with COVID-19. Following provision of informed consent, patients will be administered around 500 mL of convalescent plasma obtained from an individual who has recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety outcomes include serious adverse events judged to be related to convalescent plasma. Other information which will be collected includes patient demographics and clinical data which includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and 28-day mortality.