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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To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
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This is a prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.
University Medicine Greifswald
The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccination effects
Hospital Universitario Ramon y Cajal
The COVID-19 Androgen Sensitivity Test is a non-invasive In-Vitro Diagnostic device that utilizes Next Generation Sequencing Technology (NGS). The results of the test are used by a physician to assess the risk of developing severe symptoms following COVID-19 infection, The COVID-19 Androgen Sensitivity Test requires a health care professional to collect a DNA sample using an FDA cleared DNA sample collection kit.
University Hospital, Lille
The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.
Consorci Sanitari de Terrassa
Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19 cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptor blockers (ARB), since this virus shares hemagglutinin as a transmission mechanism and acts on the ACE2 enzyme during infection. Other authors described how none of the elderly patients receiving antihistamines and azythromycin in two nursing homes in Toledo -Spain- during the first wave died or needed hospital admission, even considering that 100% of residents had a positive serological test after that wave. Other authors have described a positive evolution in patients receiving amantadine for their Parkinson's disease. The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving these treatments showed a better evolution.
Tan Tock Seng Hospital
The Coronavirus Disease 2019 (COVID-19) pandemic has placed tremendous stress on the global economy since its outbreak in December 2019. Currently, with nearly 1.3 million confirmed cases, there is still no effective way to contain the disease. The transmission of COVID-19 occurs via direct (prolonged close interaction, within 2 meters for more than 30 minutes) and indirect (fomites) contacts. Locally, the risk of COVID-19 infection in household contacts of confirmed cases is about 4%. These at-risk individuals are identified through contact tracing and infectious may be preventable using post-exposure-prophylaxis (PEP). However, there has yet to be a single effective, safe, and affordable pharmacological agent with such capabilities. Hydroxychloroquine (HCQ) is a cheap anti-malarial and immunomodulatory agent which may potentially be used as PEP against COVID-19. HCQ is capable of blocking the invasion and intracellular replication of the virus. Existing studies have reported efficacy of HCQ in treating COVID-19, with reduced time to clinical recovery and few reports of patients suffering from significant side effects. However, existing studies are largely limited by their small sample sizes. Furthermore, there has yet to be a published trial on HCQ's role in PEP. This cluster randomized trial will evaluate the safety and efficacy of oral HCQ PEP, taken over for 5 days, in reducing the number of infected household contacts of confirmed COVID-19 patients under home quarantine. Comparison will be made between HCQ PEP (treatment group) and no treatment (control group). Subjects will be followed up over a course of 28 days, with daily symptom monitoring conducted over phone calls. Positive outcomes from this study will provide a means for us to battle the COVID-19 pandemic.
University of Miami
The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection
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.
Hospices Civils de Lyon
Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests
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.