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 240 of 295Sanofi
Primary Objectives: - Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal cytogenetic subtype on participant outcome Randomized Phase 3 - Key Secondary Objectives: To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survival Other Secondary Objectives: To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)
Centre Hospitalier Universitaire de Saint Etienne
Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection. To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.
Qurient Co., Ltd.
This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.
MedRegen LLC
This study consists of two parts. Part A (Phase I): A Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects to Assess the Safety, Pharmacokinetics, Pharmacodynamics of MRG-001 Part B (Phase 2): A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-controlled, Multi-center Study in Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001
Sanofi
The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma.
Massachusetts General Hospital
The primary aim of this study is to evaluate the efficacy and safety of AT1001 versus placebo in pediatric patients with SARS-CoV-2 infection who experience early signs of MIS-C and are at high risk of progression. AT1001 10 μg/kg/dose up to 500 μg/dose (rounded to the nearest 50 μg) or matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.
Beijing 302 Hospital
This is a phase III randomized, double blinded, placebo-controlled multi-center study to assess the efficacy and safety of aerosolized Novaferon for the treatment of asymptomatic or mildly patients infected with SARS-CoV-2.
Ministry of Health, Thailand
The purpose of this study is to examine the effect of Andrographis Extract, Boesenbergia Extract compared to standard treatment in asymptomatic COVID patients.
Loma Linda University
The purpose of this study is to assess the safety and efficacy of repurposing tazemetostat for the treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 patients.
Department of Health, Philippines
This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.