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 290 of 316Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells). Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted. Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women. Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
University of Siena
GEN-COVID multicenter study aims to identify the genetic variants of the host genome responsible for the clinical variability of patients with COVID-19. This variability to date is only partially related to the age and comorbidities of patients. The primary objective of the study is therefore to identify genetic variants associated with the severity of the disease, while the secondary objective consists in the identification of variants associated with longitudinal disease trajectories. This is a laboratory study that involves the conduct of genetic investigations, including whole exome sequencing and genome wide association studies, on human biological material from patients affected by COVID-19. Clinical information useful to describe the level of disease severity will be also collected for each enrolled patient. A total of at least 2,000 COVID-19 patients is expected to be included.
University of Health Sciences Lahore
The current project is based on the immunological studies covering the potential of disease induced immunoglobulins as treatment regime. We would be able to generate the concentrated antibodies specific against coronavirus (Covid-19). These antibodies can be used as serum therapy. Aside from a Covid-19 vaccine, antibodies from recovered patients could provide a short-term "passive immunization" to the disease. Those antibodies can be extracted from the blood serum of surviving patients and then injected into infected people. Passive immunization usually lasts for a few weeks or months, after which those borrowed or donated antibodies, get broken down by the host body within about 30 days. While drugs to treat patients with covid-19, and vaccines to prevent infection are being developed, a fast acting, stopgap serum therapy could be useful as a first aid for high-risk patients.
Charles Drew University of Medicine and Science
This proposal seeks to enhance acceptability and uptake of COVID-19 testing and vaccination to engage African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to reduce barriers and implement innovate strategies to engage this population in the uptake of COVID-19 testing and vaccination.
Bharat Biotech International Limited
The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152.
Dr. Reddy's Laboratories Limited
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.
Cairo University
exercise activity during the COVID pandemic is appreciated to be conducted in home especially for chronic chest diseases as chronic obstructive pulmonary disease (COPD) to reduce the chance of viral contamination during the COVID-19 pandemic.
Jiangsu Province Centers for Disease Control and Prevention
This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are >59 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.
Hospital de Clinicas de Porto Alegre
The study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Therapeutic strategies to be evaluated are Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation, as an active control. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.
Hospital de Clinicas de Porto Alegre
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. This study aims to investigate the safety and efficacy of intravenous infusion of natural killer cells patients with COVID-19.