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 970 of 1270Regeneron Pharmaceuticals
Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
AbCellera Biologics Inc.
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.
Shin Poong Pharmaceutical Co. Ltd.
This is a multi-center, randomized, Phase 2/3 study to evaluate the safety and efficacy of pyronaridine-artesunate in participants with corona virus disease 2019 (COVID-19). Pyronaridine-artesunate has been approved in Europe, Asia and Africa under brand name of Pyramax® or Artecom® as a treatment for malaria. The study will be conducted in two stages: open-label (Stage 1) and double-blind (Stage 2). Up to approximately 402 participants (20 participants in Stage 1 and 382 participants in Stage 2) are planned to be enrolled in the study and will be randomized to receive either Artecom® or matching placebo at a ratio of 1:1 in Stage 2. The dose of Artecom® will be determined by the participant's body weight, according to previously established guidelines. An independent Drug Safety Monitoring Board (DSMB) will be established to review the safety at regular intervals during the conduct of the trial. The DSMB will be subject to a Charter and will review after 20 participants have been recruited, and thereafter when 191 participants have been recruited. Ad-hoc DSMB meetings may be held at any time during the study if there are any major safety concerns. A final DSMB will be conducted when all participants have been recruited in the trial.
Aurinia Pharmaceuticals Inc.
An open-label, 56 day, single-center, exploratory, proof-of-concept study of the anti-viral effect of voclosporin (VCS) with an extended safety follow-up, up to 1 year. Study population are adult KTRs with positive SARS-CoV-2 infection with mild to moderate symptoms. At study entry, subjects are on standard therapy of dual immunosuppressive treatment of prednisone and tacrolimus (TAC), following randomization, 10 out of 20 subjects will remain on this therapy for the duration of the study, while the other 10 subjects will switch to VCS.
Catalysis SL
This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
National Institute on Aging (NIA)
The Center Disease Control has published a set of guidelines to contain the spread of the virus, since it is known to spread from person-to-person. Given the vaccine and specific antiviral treatment for Coronavirus disease (COVID-19) remain under development and will take months or years to develop, intermittent and sustained preventive behaviors may be needed into 2022 unless effective treatments or vaccines are developed. Thus, effectively implementing preventive behaviors remains a critical step in bringing the pandemic under long-term control. Leveraging the ecological momentary assessment (EMA) method developed in the parent R01 for smartphones, which allows for real-time data collection on individual's behaviors, the investigators propose a prospective single arm and longitudinal study to examine the effectiveness of self-monitoring EMA (SM-EMA) in promoting adherence to COVID-19 preventative behaviors. SM-EMA users will download the smartphone app which includes: (1) instructional videos to provide knowledge of preventative behaviors; (2) self-monitoring of preventative behaviors during intervention and follow-up phases; (3) tailored-feedback messages to encourage preventative behaviors; and (4) mobile-enabled website to provide an interactive learning platform. If proven efficacious, this intervention could be efficiently disseminated to reach the larger public and foster preventive behaviors into self-management as effective strategies for long-term control of the COVID-19 pandemic.
Derek Yellon
The coronavirus disease (COVID-19) emerged in late 2019 and has since been diagnosed in over a million persons worldwide. As this virus progresses, it causes an extreme and uncontrolled response from the patient's immune system accompanied by reduced oxygen flow to major organs, and subsequent ischaemic injury. The current treatment of COVID-19 is largely supportive without any cure or vaccine available at this time. Developing new methods to reduce this heightened inflammatory response is essential to halting progression of COVID-19 in patients and reducing the severity of damage. The cellular mechanisms seen in COVID-19 are similar to those seen in patients with sepsis. A process known as Remote Ischemic Conditioning (RIC) is an intervention which has been shown to prevent cellular injury including those associated with sepsis. Based on the evidence from studies looking at sepsis, it is anticipated the same benefit would be seen in patients diagnosed with COVID-19. RIC is a simple, non-invasive procedure where a blood pressure cuff is applied to the arm for repeated cycles of inflating and deflating (typically 3-5 cycles of 5 minutes each). This process activates pro-survival mechanisms in the body to protect vital organs and improve the immune system. Therefore, we believe it represents an exciting strategy to protect organs against reduced blood flow and extreme immune response, as seen in COVID-19 infections. This study has already been fully approved
Jessa Hospital
The SARS-CoV-2 pandemic causes a major burden on patient and staff admitted/working on the intensive care unit (ICU). Short, and especially long admission on the ICU causes major reductions in skeletal muscle mass (3-4% a day) and strength. Since it is now possible to reduce mortality on the ICU, short and long-term morbidity should be considered another principal endpoint after SARS-CoV-2 infection. Cachexia is defined as 'a complex metabolic syndrome associated with underlying illness and characterized by loss of muscle mass'. Its clinical features are weight loss, low albumin, anorexia, increased muscle protein breakdown and inflammation. There is strong evidence that cachexia develops rapidly in patients hospitalized for SARS-CoV-2 infection, especially on the ICU. Several mechanisms are believed to induce cachexia in SARS-CoV-2. Firstly, the virus can interact with muscle cells, by binding to the angiotensin converting enzyme 2 (ACE-2). In vitro studies have shown the virus can cause myofibrillar fragmentation into individual sarcomeres, in addition to loss of nuclear DNA in cardiomyocytes. Similar results were found during autopsies. On a cellular level, nothing is known about the effects of SARS-CoV-2 infection on skeletal muscle cells. However, up to 19.4% of patients present with myalgia and elevated levels of creatine kinases (>200U/l), suggesting skeletal muscle injury. Moreover, patients with SARS-CoV-2 infection are shown to have elevated levels of C-reactive protein and other inflammatory cytokines which can all affect skeletal muscles. The above mentioned factors are not the only mediators by which skeletal muscle mass might be affected in SARS-CoV-2. There are other known factors to affect skeletal muscle mass on the ICU, i.e. immobilization and mechanical ventilation, dietary intake (anorexia) and inflammatory cytokines. SARS-CoV-2 infection in combination with bed rest and mechanical ventilation can lead to severe muscle wasting and functional decline resulting in long-term morbidity. Until know there are no studies investigating acute skeletal muscle wasting in patients infected with SARS-CoV-2 and admitted to the ICU. As a result, there is a need of more in-depth understanding the effects of SARS-CoV-2 infection on muscle wasting. An optimal characterization of these effects may lead to improvement in morbidity and even mortality in the short and long term by the establishment of evidence-based rehabilitation programs for these patients.
Laval University
People with chronic diseases including atherosclerotic heart disease, high blood pressure and diabetes are considered as a group with a high vulnerability. The COVID-19 pandemic ranging the world is rendering these people with chronic diseases even more vulnerable as they are subjected to a higher risk of COVID-19 related complications. General recommendations issued by the public health departments (PHD) do not take into consideration the personal situation of every citizen and therefore do not provide a personalized guidance to people with high vulnerability. The investigators hypothesis is that if participants receive adapted and personalized public health recommendations, they will be more adherent to the recommendations issued by the PHD and have better health outcomes than those who receive only general recommendations. In the current trial, the investigators propose to co-develop a web-based portal (Vigie-COVID) that provides tailored recommendations based on the situation of each participant and adapted to the COVID-19 status, the behavior risk associated to contamination, the risk of complications and the health risks related to confinement. Using a cohort of people aged 18 and over in the province of Quebec, this randomized clinical trial will use a nested a double-blind experimental design where the tailored recommendations will be compared to the general recommendations of the PHD. The expected results from this trial include: 1) Improvement in the rate of compliance with the PHD recommendations in the group receiving the tailored recommendations; 2) Improvement of the quality and the quantity of the COVID 19 epidemiological data available for population health research in the Quebec region; 3) Decrease in the load in clinics (self-diagnosis); 4) Improving the state of health of individuals. The portal will be co-constructed in collaboration between various key players (citizens, patient partners, clinicians, researchers, companies, managers, decision-makers and representatives of the PHD) and aims to allow the recommendations of the PHD to be tailored according to the specific situation of each citizen-user in order to promote preventive behavior in times of pandemic. Overall, the ultimate goal is to obtain a global epidemiological portrait in order to identify the determinants and indicators of sustainable health and their impacts. After the pandemic, this might enable the implementation of a personalized monitoring of chronic diseases.
Ankara University
The world is facing an extremely important global epidemic. Coronavirus disease 2019 (COVID-19) epidemic, which first appeared in Wuhan, China in late 2019 and rapidly affected all countries of the world, was declared as a pandemic by the World Health Organization (WHO) on March 11, 2020. Coronavirus disease 2019 affects both the upper (i.e. sinuses, nose and throat) and lower (i.e. trachea and lungs) airways, causes respiratory tract diseases ranging from asymptomatic or cold to more severe lung diseases (Acute Respiratory Distress Syndrome-ARDS). COVID-19 has many symptoms (i.e. fever, loss of appetite). In cases where the disease has a more severe course, in addition to the symptoms mentioned above, complications such as a severe pneumonia, acute respiratory distress syndrome (ARDS) kidney failure and fatal heart damage may develop. Dyspnea is one of the most prominent symptoms for COVID-19. Since COVID-19 affects the respiratory system, pulmonary rehabilitation has an important place in the treatment of patients. Dyspnea is one of the most prominent symptoms for COVID-19. Our clinical observations are of the opinion that dyspnea is observed even in patients with mild COVID-19 pneumonia. Applying deep breathing exercise with triflo in COVID-19 patients, can contribute to relieving dyspnea, reducing / eliminating anxiety, and increasing quality of life. In the light of this information, the aim of this study is to determine the effect of deep breathing exercise with triflo on dyspnea, anxiety and quality of life in patients with dyspnea who are hospitalized for COVID-19. Research Hypotheses H1: Patients with COVID-19 pneumonia who undergo deep breathing exercise with triflo will have a lower dyspnea level than the patient group in which this exercise is not applied. H2: Patients with COVID-19 pneumonia who underwent deep breathing exercise with triflo will have a lower anxiety level than the patient group in whom this exercise was not applied. H3: Patients with COVID-19 pneumonia who underwent deep breathing exercise with triflo will have a higher quality of life than the patient group in whom this exercise was not applied.