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 50 of 203National University of Ireland, Galway, Ireland
Coronavirus disease 2019 (COVID-19) is a pandemic infection caused by a virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Because SARS-CoV-2 is known to require the angiotensin-converting enzyme 2 (ACE-2) receptor for uptake into the human body, there have been questions about whether medications that upregulate ACE-2 receptors might increase the risk of infection and subsequent complications. One such group of medications are anti-hypertensives that block the renin-angiotensin system, including both angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB). Both ACEi and ARB are widely used for the treatment of hypertension. Early reports from China and Italy suggest that many of those who die from COVID-19 have a coexisting history of hypertension. Consequently, there have been questions raised as to whether these 2 types of blood pressure medication might increase the risk of death among patients with COVID-19. However, it is well known that the prevalence of hypertension increases linearly with age. Therefore, it is possible that the high prevalence of hypertension and ACEi/ARB use among persons who die from COVID-19 is simply confounded by age (older people are at risk of both a history of hypertension and dying from COVID-19). Whether these commonly prescribed blood pressure medications increase the risk of COVID-19 or not remains unanswered. Statements from professional cardiology societies on both sides of the Atlantic have called for urgent research into this question. Our study aims to randomize patients with primary (essential) hypertension who are already taking ACEi/ARB to either switch to an alternative BP medication or continue with the ACEi/ARB that they have already been prescribed. Adults with compelling indications for ACEi/ARB will not be enrolled.
Azidus Brasil
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.
Sunnybrook Health Sciences Centre
This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.
Ola Blennow, MD, PhD
Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is duration of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.
Tanta University
Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.
University of Oxford
RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia. The treatments being investigated are: COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only) Influenza: Baloxavir marboxil, Oseltamivir, Low-dose corticosteroids - Dexamethasone Community-acquired pneumonia: Low-dose corticosteroids - Dexamethasone
Sanofi
Primary Objective: To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D) Secondary Objectives: - To characterize the safety profile of SAR442257 - To characterize the pharmacokinetics (PK) profile of SAR442257 - To evaluate the potential immunogenicity of SAR442257 - To assess preliminary evidence of antitumor activity
Farmoquimica S.A.
This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.
Sanofi
Primary Objectives: - Part 1 - To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. - To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors. - Part 2 - To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab. - Part 3A - To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC - To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC - Part 3B - To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC - Part 4 - To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab. - To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab. Secondary Objectives: - Part 1 - To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. - To estimate the anti-tumor effects of SAR442720 with pembrolizumab. - Part 2 - To assess the safety profile of SAR442720 combined with pembrolizumab. - To assess other indicators of anti-tumor activity. - To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. - Part 3A - To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. - To estimate the anti-tumor effects of SAR442720 with adagrasib - Part 3B - To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC. - To assess other indicators of anti-tumor activity. - To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. - Part 4 - To assess the safety and tolerability of SAR442720 formulations with pembrolizumab - To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
Instituto de Investigación Marqués de Valdecilla
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.