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.
Displaying 680 of 748Region Skane
Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.
Natureceuticals Sdn Bhd
A two arm open label multi-centered randomized interventional trial is proposed to assess aspects of safety and efficacy of Nuvastatic™ (Serial No: C5OSEW5050ESA) . Two parallel groups of (1:1) ratio comparing Nuvastatic™ versus standard care will be conducted on patients on oxygen saturation (SaO2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (PaO2:FiO2) at or below 300 mg Hg. Primary Outcome Measures: time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever comes first. Secondary Outcome Measures: Clinical status as assessed with the seven-category ordinal scale on days 7 and 14, mortality at day 28. 1. The duration of mechanical ventilation. 2. The duration of hospitalization in survivors. 3. The time (in days) from treatment initiation to death. 4. Virologic measures included the proportions with viral RNA detection over time and viral RNA titer area under-curve (auc) measurements.
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.
Children's Hospital of Philadelphia
Initial data from COVID-19 patients suggests that one of the primary causes of death is significant endothelial injury leading to blood clotting and impaired multiorgan microvascular perfusion. The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to estimate the extent of microvascular perfusion impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients in vivo and assess the significance of imaging findings by correlating to clinical outcomes. This pilot study will be conducted at one site, The Children's Hospital of Philadelphia. We will enroll and evaluate 30 patients.
Genoscience Pharma
This is a multicenter, open-label, controlled, randomized phase 2 study designed to evaluate the safety and efficacy profile of GNS561 in patients with COVID-19.
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
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.
Henry M. Jackson Foundation for the Advancement of Military Medicine
The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed. Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection. This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers. A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.
praxisgemeinschaft für zelltherapie
Currently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C. In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.