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 350 of 1315I-Mab Biopharma Co. Ltd.
This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.
Tabula Rasa HealthCare
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled in PACE organizations. Our clinical tool would enable to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in elderly patients infected with COVID-19.
University Hospital, Ghent
ONCOVID is a prospective cohort study investigating oncology-patient-reported anxiety, mood, and quality of life during the COVID-19 pandemic. Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (COVID-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, and WHO Quality of Life-BREF). Data collection occurs at baseline and follow-up surveys are performed after 6, 12, and 24 weeks.
Cyprus Science University
The aim of this study is to assess the changes in the dietary habits of adults spending most of their time in their homes due to the Coronavirus (COVID-19) outbreak. Eating habits of individuals may vary greatly depending on several factors such as geographic location, socioeconomic conditions, education level, knowledge about nutrition and psychological factors. Since this period of quarantine is economically and psychologically stressful, we hypothesise that individuals may alter their usual eating habits.
University Hospital, Strasbourg, France
Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization. Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will be able to follow up patients and perform complementary investigations according to patients injuries.
University of Brasilia
The use of nanomaterials in semi-facial respirators could decrease the permeability of particles and promote a biocidal effect compared to conventional respirators (N95) and, therefore, to enhance the filtering power, aiming to mitigate harmful effects of bacteria and viruses. Chitosan is a natural cationic polymer derived from chitin, with characteristics such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity. This polymer has virucidal activity in several types of viruses, including other coronaviruses, given the attractive factor of its cationic charge for negative charges. The effectiveness of a novel individual protection semi-facial respirator (called VESTA) will be investigated, compared to a conventional N95 respirator. The respirators will be tested in healthcare professionals working in hospital environments and the effectiveness will be attributed to the lower incidence rate of infection by the SARS-CoV-2, and to the ability to filter these viruses after use by healthcare professionals exposed to potentially contaminated environments. The study will be carried out in two stages: i) Randomized Controlled Trial with reduced sample to confirm the sample size calculation (pilot trial), and ii) Randomized Controlled Trial (RCT). The RCT will be conducted with healthcare professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital sectors with greater vulnerability to infection (urgency, emergency and intensive care units). The RCT will be conducted initially with a group of sixty participants (n = 30 in each group) for initial investigation of the potential for efficacy with the use of the respirators (VESTA and conventional N95) in two sectors (emergency and ICU) in a reference Hospital for COVID-19. The RCT will consist of two parallel groups: (1) Experimental Group (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use the standard respirator (N95). Participants will be recruited from participating hospitals and will be accompanied by 21 days in approximately eight consecutive shifts (ranging from shifts lasting 6 to 12 hours each, followed by approximately 36 hours of rest). Participants will be assessed at baseline (T0), at the end of the 10th day (T1), and at the end of the 21st day (T2).
Reata Pharmaceuticals, Inc.
This multi-center, double-blind, placebo-controlled, randomized Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in patients hospitalized with confirmed COVID-19. The trial will include approximately 40 patients and is designed to provide an early interim analysis of safety. Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo and treatment will be administered for the duration of hospitalization (until recovery), with a maximum treatment duration of 29 days.
The University of Queensland
This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.
Instituto Grifols, S.A.
The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Coronavirus is an acute viral disease with prevailing upper respiratory tract infections caused by the RNA-containing virus of the genus Betacoronavirus of the Coronaviridae family. Most patients with severe COVID-19 develop pneumonia in the first week of the disease. As the infection progresses, the infiltration increases, and the affected areas increases. Excessive and uncontrolled immune system response with rapidly developing fatal cytokine storm plays the main role in the pathogenesis of acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 infection. According to available data, exosomes can regulate inflammation and regenerative processes due to the change in the concentration of anti-inflammatory cytokines and switch the immune cell to regenerative secretome. Inhalation of exosomes may reduce inflammation and damage to the lung tissue and stimulate the regenerative processes. This protocol has been developed based on the literature, information about the ongoing tests NCT04276987 (A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia) and NCT04384445 (Organicell Flow for Patients With COVID-19), Patent No 271036826 of 2019. "A method for obtaining and concentrating microRNA-containing exosomal multi-potent mesenchymal-stromal cells for use in cosmetic and pharmaceutical products to stimulate regenerative processes and slow down aging.