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 1130 of 1421Hellenic Cooperative Oncology Group
This is an observational study that will prospectively record and monitor responses and clinical outcomes of patients with cancer after covid-19 vaccination, including measurements of antibody titers in serum and also record potential factors that affect immunity, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.
Prothione, LLC
The study is a phase 2 proof of concept study. The purpose of this study is to assess the efficacy and safety of Prothione™ capsules administered orally twice a day for 30 days in subjects with mild to moderate COVID-19. The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. The issued patents relevant to Prothione™ capsules and the treatment of viral disease include: • Nutritional or Therapeutic Compositions and Methods to Increase Bodily Glutathione Levels: 1. US Patent No. RE 42,645 2. Japanese Patent No. 5601745 3. European Patent No. 1556023 4. Canadian Patent No. 2539567 5. Australian Patent No. 2010201136 • Protective Metallothionein Analog Compounds, Their Compositions and Use Thereof in the Treatment of Pathogenic Disease: 6. Canadian Patent No. 2963131 7. Australian Patent No. 2018279015
Portsmouth Hospitals NHS Trust
Point of care testing is urgently required to enable the immediate detection of SARS-CoV-2 infection to allow effective transmission prevention precautions to succeed.
Coalition for Epidemic Preparedness Innovations
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded, age-escalating study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with Alum in healthy younger and older adults.
University of Sydney
In this trial, we are evaluating the safety and tolerability of a new investigational DNA vaccine to protect against SARS CoV-2 virus, called COVIGEN, that is developed by a company called BioNet-Asia. A device will be used to inject the vaccine that does not require the use of a needle (needle-free injection made by a company called Pharmajet). For delivery into the skin (intradermally) a device called "Tropis" will be used, and for delivery into the muscle (intramuscularly) a device called "Stratis" will be used. This is a 2 part study In Part A vaccine naive participants will be given 2 vaccinations, either two active vaccines or two placebo vaccines on Day 1 and Day 29. COVIGEN C19 vaccine will be used in Part A In Part B participants who have previously received a 2-dose primary COVID vaccine schedule will be given a booster dose of active vaccine. COVIGEN C20 vaccine will be used in Part B. Participants in part A and B will be followed up using a combination of on-site and telephone visits for assessment of safety and immunogenicity for 12 months from 1st vaccination.
University Medical Center Groningen
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded patients with chronic kidney disease (CKD) so-far. Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls. Study design: prospective, controlled multicenter study Study population: 175 patients with CKD stages 4/5 (eGFR < 30 ml/min/1.73m2), 175 on dialysis , 300 alive with a kidney transplant and 200 controls (partners or sibblings of patients) Intervention: SARS-CoV-2 vaccination according to standard of care. Blood will be drawn at 4 different time points (baseline and at day 28, month 6 and in a subset 28 days after a third vaccination). Main study parameters/endpoints: The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as responders or non-responders based on a spike (S)1 specific antibody levels of >=10 or
Misr International University
Coronavirus disease 2019 (COVID-19) remains a threatening pandemic, due to its rapid transmission, uncertain risk factors for progression that lead to its lethality and yet unsatisfactory antiviral therapy or prophylaxis. The respiratory system remains the most frequently affected by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2), with patients either presenting mild illness as well as more severe complications such as acute respiratory distress syndrome (ARDS) that necessitates admission in Intensive Care Units (ICU). Unfortunately, the remaining patients progress to a second phase-called the inflammatory stage-featuring ARDS, thromboembolic events, and myocardial acute injury. These clinical exacerbation latter predicts poor prognosis associated with an exacerbation of the immune system cascade; a phenomenon known as "cytokine storm". In the context of COVID-19, the hyper inflammation diagnostic criteria are partly defined. Early studies of patients with COVID-19 established independent associations between biomarkers of inflammation, such as C-reactive protein, interleukin [IL]-6, ferritin and D-dimer, and severe disease states that require respiratory support or result in death. The aim of this study was to identify practical blood immune- inflammatory biomarker / ratio that could be used alternatively to IL-6 for predicting severity of coronavirus disease 2019 (COVID- 19) in clinical practice. Another aim is to unveil the association of the pro-inflammatory profile as categorized by the IL-6 levels in patients infected by SARS-COV-2, with disease severity and outcomes of COVID -19.
Sciensano
Assessment of the seroprevalence and sero-incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) among Nursing Home (NH) residents and staff in Belgium.
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.