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 50 of 134Regeneron Pharmaceuticals
Primary Objective:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPDSecondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Kafrelsheikh University
Investigating the role of 13cis retinoic acid in the treatment of COVID-19 andenhancement of Its spike protein based vaccine efficacy and safety.
University of Minnesota
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patientson mechanical ventilation.
Climate Foundation
At least 1 in 6 COVID-19 patients admitted to hospital to receive extra oxygen will dieof complications. In patients with COVID-19, invasive treatment such as mechanicalventilation (e.g. breathing with a machine) is associated with a 50% increased risk ofdeath. Invasive treatments use a lot of healthcare resources in intensive care units andmay lead to further deaths if patients do not have access to care.The investigators aim to improve outcomes for COVID-19 patients by implementinghyperbaric oxygen therapy (HBOT). HBOT allows patients to breathe 100% oxygen in aspecial chamber at a pressure higher than sea level. It is approved by Health Canada for14 conditions. HBOT is safe when administered by experienced teams.There are two main causes of death in severe COVID-19 respiratory infections: (i) adecreased diffusion of oxygen from the lungs to the blood and (ii) an increasedinflammatory response (also called a "cytokine storm"). HBOT leads to increased oxygenlevel in blood, has strong anti-inflammatory effects, and may destroy the virusresponsible for COVID-19 disease. The initial experience with HBOT and COVID-19 fromChina, France and the United States is promising in that it prevents further worsening ofthe condition and need for intensive care.The investigators propose to test the effectiveness of HBOT for COVID-19 patients who areadmitted to hospital to receive extra oxygen. Using the most rigorous and innovativeresearch methods, this Canadian-led international study will operate at 5 centers across3 countries (Canada: Ottawa, Toronto, Edmonton; Switzerland: Geneva; UK: Rugby/London).The investigators anticipate that when treated by HBOT, COVID-19 patients needing extraoxygen to breathe will see significant health improvements as well as a decrease incomplications, inflammation in the blood, need for invasive care, death, and cost ofcare.
Medical University of South Carolina
The purpose of this study is to evaluate how useful vitamin D supplementation is inreducing the severity of COVID-19 symptoms and the body's inflammatory andinfection-fighting response to COVID-19. Individuals ≥50 years of age and older who aretested for COVID-19 and negative will be randomized (like flipping a coin) to eitherdaily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care.Those individuals ≥50 years of age or older who test positive for COVID-19 at baselinewill be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose(6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receivea multivitamin containing vitamin D.
Humanetics Corporation
This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate thesafety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lungfunction in patients that were hospitalized for severe COVID-19-related illness andcontinue to experience post-acute respiratory complications associated with Long-COVIDafter discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.
Brigham and Women's Hospital
Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminalcomplement products and is proposed for the treatment of COVID-19 inducedmicrovasculature injury and endothelial damage leading to thrombotic microangiopathy(TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants witha confirmed diagnosis of COVID-19 who clinically or diagnostically present withdeteriorating renal function. Ravulizumab causes immediate and sustained inhibition ofthe terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 inducedkidney injury due to TMA, shorten hospital stay, and improve the overall survival.
Karolinska Institutet
Prospective, single center, randomized, open label, parallel group, 2-arm study assessingthe clinical benefit in term of enhancement of overall response rate of Isatuximab incombination with CellProtect as compared to Isatuximab for the treatment of patients withnewly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) asmaintenance after SCT.
Sanofi
Primary Objective:To determine the efficacy of SAR442168 compared to placebo in delaying disabilityprogression in primary progressive multiple sclerosis (PPMS)Secondary Objectives:To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magneticresonance imaging (MRI) lesions, cognitive performance, physical function, and quality oflife To evaluate safety and tolerability of SAR442168 To evaluate populationpharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety Toevaluate pharmacodynamics of SAR442168
Pfizer
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 asMonotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors