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.
Search Tips
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.
Displaying 2830 of 2833Guangzhou Blood Center
In December 2019, an unknown pneumonia rapidly spread in Wuhan, China, a new coronavirus, 2019 novel coronavirus (2019-nCoV), aroused the attention of the entire world. On January 31, 2020, World Health Organization (WHO) announced the outbreak of Coronavirus Disease 2019 (COVID-19) in China as a Public Health Emergency of International Concern. The number of volunteer non-remunerated blood donors decreased because of quarantine, caring for relatives, and fear of exposure to COVID-19. Due to the blood shortage, patient blood management and cessation of elective surgery are contributing to decreased demand, but sepsis may increase requirements and significant reductions will not be possible in areas such as trauma, cancer patients, hereditary haemolytic anaemias and childbirth. Therefore, recruiting enough blood donors during the epidemic is vital for public health in China, and also worldwide. In order to assess the effects of a questionnaire on blood donor recruitment, the investigators designed two kinds of self-administered, standardized and structured questionnaires. In addition of the basic socio-demographic characteristics, one questionnaire includes the information of precautions of blood donation during epidemic, and the other dose not. The questionnaires were randomly sent to ever blood donors, and the same number of ever blood donors are coded as control.
Tongji Hospital
Observe the efficacy and safety of G1(Sildenafil citrate tablets) in patients with COVID-19 under clinical actual diagnosis and treatment conditions
FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
This study is a research project to evaluate the efficacy of hydroxychloroquine for post-exposure prophylaxis and early treatment of Covid-19. The intervention entails administering prophylactic hydroxychloroquine to all contacts (Study 1) and treating non severe confirmed cases with hydroxychloroquine (Study 2).
CAR-T (Shanghai) Biotechnology Co., Ltd.
Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells
Shenzhen Geno-Immune Medical Institute
In December 2019, viral pneumonia (Covid-19) caused by a novel beta-coronavirus (SARS-CoV-2) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins. This trial proposes to develop universal vaccine and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify artificial antigen presenting cells (aAPC) and to activate T cells. In this study, the safety and immune reactivity of this aAPC vaccine will be investigated.
University of Macau
Background: Direct exposure to public health emergencies is associated with increased mental disorders. It is less clear about the prevalence of common mental disorders and its correlates in Chinese adolescents after experiencing public health emergencies. Objective: This longitudinal study aims to estimate the prevalence of common mental disorders (i.e. depression, anxiety, and post-traumatic stress disorder) and its correlates in a sample of Chinese adolescents after experience a public health emergency, namely the novel coronavirus disease 2019 (COVID-19). Method: This study intends to recruit 3,428 Chinese adolescent students from high and middle schools in the baseline survey. This study will track these recruited participants every 6 months via three-wave follow-up (i.e. 6-month, 12-month, and 18-month follow-ups). The demographics (e.g. age, gender, education, family background, and residence) and psychosocial factors (i.e. exposure to traumatic events, religious belief, social media exposure, loneliness, and perceived social support) associated with common mental disorders (i.e. depression, anxiety, and post-traumatic stress disorder) will be investigated in this sample population. Furthermore, a hardcopy self-report questionnaire will be disturbed to all participants. Additionally, the cross-sectional analyses will be first conducted to estimate the prevalence of mental disorders and their correlates in data of baseline survey. After obtaining the longitudinal data, the relative risk, incident rate ratios, latent class analysis, and structural equation model may be performed in this study. Missing data will be solved by the multiple imputations. Data analysis tools included the Stata 16.0 and Mplus 8.4. Discussion: This longitudinal study will better help to understand the prevalence changes of mental disorders among Chinese adolescents following the COVID-19. These findings have the potential to provide empirical evidence about the burden of mental disease and key drivers of Chinese adolescents following the COVID-19, which can benefit the formation of public policy and mental health intervention programming. This study will close the gaps that a lack of epidemiological studies about the mental disorder prevalence and related risk factors.
Tongji Hospital
To analyze the intubation with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.
Ansun Biopharma, Inc.
This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.
Rajavithi Hospital
A 6-Week Prospective, Open label, Randomized, in Multicenter Study of, Oseltamivir 300mg per day plus Hydroxychloroquine 800 mg per day versus Combination of Lopipinavir 800mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200 mg (or 2.5 mg/kg ) per day plus Oseltamivir 300mg ( or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day in mild COVID-19 and Combination of Lopipinavir 800 mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Lopipinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200 mg (or 2.5 mg/kg ) plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Hydroxychloroquine 400 mg per day in moderate to critically illness in COVID-19