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 60 of 370Kitasato University
Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when thesymptom and clinical findings exacerbate to a moderate level, patients are admitted.There is no standard treatment for mild cases. This study will investigate whetherivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderateCOVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlledtrial. Subjects are assigned to two groups, the placebo group, and the ivermectin group.The target number of each treatment arm is 120, a total of 240 cases. A single oraladministration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will beadministered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primaryendpoint with additional efficacy and safety of the process will be investigated.
Regeneron Pharmaceuticals
Primary Objective:Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acutemoderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives: - 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 COPD
Shin Poong Pharmaceutical Co. Ltd.
This is a multi-center, randomized, Phase 2/3 study to evaluate the safety and efficacyof pyronaridine-artesunate in participants with corona virus disease 2019 (COVID-19).Pyronaridine-artesunate has been approved in Europe, Asia and Africa under brand name ofPyramax® or Artecom® as a treatment for malaria. The study will be conducted in twostages: open-label (Stage 1) and double-blind (Stage 2).Up to approximately 402 participants (20 participants in Stage 1 and 382 participants inStage 2) are planned to be enrolled in the study and will be randomized to receive eitherArtecom® or matching placebo at a ratio of 1:1 in Stage 2. The dose of Artecom® will bedetermined by the participant's body weight, according to previously establishedguidelines.An independent Drug Safety Monitoring Board (DSMB) will be established to review thesafety at regular intervals during the conduct of the trial. The DSMB will be subject toa Charter and will review after 20 participants have been recruited, and thereafter when191 participants have been recruited.Ad-hoc DSMB meetings may be held at any time during the study if there are any majorsafety concerns. A final DSMB will be conducted when all participants have been recruitedin the trial.
Assiut University
To register pathological events occurring to all acute coronary syndrome patients comingto Assiut university heart hospital through one year during COVID- 19 pandemic
Corporacion Parc Tauli
The purpose of this study is to monitor short-term changes in tissue oxygen saturationand local blood flow as results of changing from supine to prone position in ARDSCOVID-19 patients
Sheba Medical Center
The study aim to test proof of concept of CBD treatment for efficacy and safety inpatients suffering with mild COVID-19 infection. The CBD will be delivered via oildroplets not containing THC, compared to placebo.
Corat Therapeutics Gmbh
Primary objectives Part 1: - To evaluate the safety and tolerability of COR-101 compared to placeboSecondary objectives Part 1: - To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19 - To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101
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 evaluatesafety 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 Assessthe Safety, Pharmacokinetics, Pharmacodynamics of MRG-001Part B (Phase 2):A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-controlled, Multi-center Studyin Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess theSafety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19
A randomized, double-blind, placebo-controlled international multicenter clinical trialdesign will be adopted. A total of 29,000 subjects aged 18 years and above are planned tobe recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years andabove in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years andabove will be recruited outside China. Safety and immunogenicity will be evaluated amongthe Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among thesubjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 andabove from outside China and all subjects from China will be selected as theimmunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2neutralizing antibody and RBD protein binding antibody will be detected by blood samplingbefore vaccination, 14 days and 6 months after full course of vaccination to evaluate theimmunogenicity and immune persistence.