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 500 of 519King's College London
The Covid-19 viral pandemic has caused significant global losses and disruption to all aspects of society. One of the major difficulties in controlling the spread of this coronavirus has been the delayed and mild (or lack of) presentation of symptoms in infected individuals, and the insufficient Covid-19 testing capacity in the UK. This warrants the development of alternative diagnostic tools that reliably assess Covid-19 infection in the early stages of infection, while also being low- cost, low-burden, and easily administered to a wide proportion of the population. This study aims to validate machine learning models as a diagnostic tool that predicts infection with SARS-CoV-2 based on app-reported symptoms and phenotypic data, against the 'gold-standard' swab PCR-test. This study will take place within the Covid Symptom Study app, the free symptom tracking mobile application launched in March 2020.
AGIR à Dom
Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19. This hypothesis is supported by numerous preclinical and theoretical arguments, as well as by some Chinese clinical studies (the Chinese guidelines for the management of Covid-19 recommend the inhalation of hydrogen), a recommendation whose interest has just been confirmed by a publication describing the very positive results of a clinical study in China. Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19. The ingestion of water saturated with molecular hydrogen has been the subject of several clinical studies in other indications than Covid-19, and no side effects of this ingestion have been reported. A recent publication recommends initiating clinical trials using a hydrogen fortified beverage.
Liaquat University of Medical & Health Sciences
This study is aimed to investigate the treatment vitamin D3 as complementary therapy with routine care for early mild symptoms of COVID-19 in outpatients setting.
Romark Laboratories L.C.
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
University of Toronto
The Açaí trial will be testing if the açaí berry extract, a safe natural product with anti-inflammatory properties, can be used as a treatment option in adult patients with COVID-19 in the community.
Fundacion Clinica Valle del Lili
A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.
ResApp Health Limited
Decentralized clinical study designed to collect further cough sounds, self-reported symptoms, and medical treatment questionnaires from participants enrolled on the COVID-Cough Study ("Study 1"). The aim of this further data collection study ("Study 2") is to: 1. develop an understanding of changes in cough sounds associated with COVID-19 and how they alter during the disease; 2. develop an understanding of other causes of COVID-19-like symptoms and their associated cough sound patterns; and 3. gain a broader understanding of the clinical outcomes of individuals who present for COVID-19 testing.
Hôpital Européen Marseille
The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), an emerging coronavirus, which has already infected 192 million people with a case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have a critical form with organ failure. Among critical patients admitted to intensive care, about 70% of them will require ventilatory assistance by invasive mechanical ventilation (MV) with a mortality rate of 35% and a median MV duration of 12 days. The most severe lung damage resulting from SARS CoV-2 infection is the acute respiratory distress syndrome (ARDS). The virus infects alveolar epithelial cells and capillary endothelial cells leading to an activation of endothelium, hypercoagulability and thrombosis of pulmonary capillaries. This results in abnormal ventilation / perfusion ratios and profound hypoxemia. To date, the therapeutic management of severe SARS CoV-2 pneumonia lay on the early use of corticosteroids and Interleukin-6 (IL-6) receptor antagonist, which both reduce the need of MV and mortality. The risk factors of death in Intensive Care Unit (ICU) are: advanced age, severe obesity, coronary heart disease, active cancer, severe hypoxemia, and hepatic and renal failure on admission. Among MV patients, the death rate is doubled in those with both reduced thoracopulmonary compliance and elevated D-dimer levels. Patients with severe alveolar damage are at risk of progressing towards irreversible pulmonary fibrosis, the incidence of which still remain unknown. The diagnosis of pulmonary fibrosis is based on histology but there are some non-invasive alternative methods (serum or bronchoalveolar biomarkers, chest CT scan). We aim to assess the incidence of pulmonary fibrosis in patients with severe SARS CoV-2 related pneumonia. We will investigate the prognostic impact of fibrosis on mortality and the number of days alive free from MV at Day 90. Finally, we aim to identify risk factors of fibrosis.
Hemex Health
Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.
Richmond Pharmacology Limited
Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibody tests to help develop methodologies which provide fast and accurate results. Infection with coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing for COVID-19 is crucial to understand who is infected and therefore a risk to others by spreading the infection. RRI are currently carrying out the following tests: A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens helps to assess whether an individual has previously had the virus and is potentially immune B. Polymerase Chain Reaction (PCR) testing using an established method to check for active SARS-CoV-2 infections. C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples. The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) in their workforce, as well as their families (including children) and visitors to their site. Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 including incidence, prevalence, information on asymptomatic carriers and efficacy of vaccination. Furthermore, identifying individuals that are infected with SARS-CoV-2 has great potential to improve health outcomes by allowing infected individuals to seek the correct medical treatment as well as self-isolate and reduce transmission.