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 80 of 345University of Manchester
A team at the University of Manchester are developing a test that tcould be helpful in detecting immunity to the Coronavirus (which causes the COVID-19 disease) in participants with inflammatory arthritis. It is based on a flu assay has already developed; the team will replace the flu antigen with a Coronavirus antigen to see if it is effective. This project aims to develop a test to see if people who have had the virus have developed immunity to it. This could help to predict who might or might not get the disease a second time, who should stay at home to be protected from potential infection or who will not develop any symptoms, even if exposed to the virus. When vaccination trials against the Coronavirus will be launched, this test could also help to see if the vaccine is effective.
Inmune Bio, Inc.
The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.
State University of New York - Downstate Medical Center
Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.
OSF Healthcare System
To compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.
Alexion
This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.
Art of Living Foundation
This study will examine the feasibility of conducting an online Randomized Controlled Trial (RCT) in frontline hospital and long term care healthcare staff in managing COVID-19 patients in London, ON. The study will randomize participants to Sudarshan Kriya Yoga (SKY) or a Health Enhancement Program (HEP).
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.
Assistance Publique - Hôpitaux de Paris
The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.
University Hospital Tuebingen
The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>9500) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect was seen when hydroxychloroquine was used together with azithromycin in a small series of COVID-19 patients. However, so far all published evidence is based on non-controlled use of hydroxychloroquine. We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease in Germany to assess virological efficacy, tolerability and safety of hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post-exposure prophylaxis of COVID-19.
University of Karachi
Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing at mass scale. Simple cost effective intervention against the present pandemic is highly desirable. For patients: Identifying an antiviral gargle that could substantially reduce the colonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viral load. Such reduction in the viral load through surface debridement could aid the effective immune response in improving the overall symptoms of the patients. For dentists: This study is important because the nature of the dental profession involves aerosol production, carrying out dental work on asymptomatic patients carrying coronavirus puts the entire dental team at a great risk of not only acquiring the infection but also transmitting it to the others. Antiviral gargles could be used by dentist and their auxiliaries as prophylaxis. For physicians and nurses: The risk of morbidity and mortality is high among physicians and nurses involved in the screening and management of Covid-19 patients. Globally, over 215 physicians and surgeons have died while taking care of Covid-19 patients. The cause of death is attributed to high exposure of viral load. The antiviral gargles and nasal lavage can decrease the fatalities among doctors and nurses. Thus, patients, physicians, nurses and dentists, all could be benefited with this findings of this study.