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 410 of 520Lawson Health Research Institute
The primary objectives of this pilot study protocol are to assess safety and feasibility of using the geko™ device in COVID-19. Regarding safety to patients, we will measure the rate of adverse events, primarily local site irritation or discomfort. Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria. Protocol adherence will be observed as the ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment. Additionally, we plan to measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.
MEDEX
The study is an unblinded, randomized, controlled trial for use of the AirFlO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR >20 breaths/min) and/or hypoxia (Oxygen saturation
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 trial design will be adopted. A total of 29,000 subjects aged 18 years and above are planned to be recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years and above in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years and above will be recruited outside China. Safety and immunogenicity will be evaluated among the Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among the subjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 and above from outside China and all subjects from China will be selected as the immunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2 neutralizing antibody and RBD protein binding antibody will be detected by blood sampling before vaccination, 14 days and 6 months after full course of vaccination to evaluate the immunogenicity and immune persistence.
Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 in participants at high risk of exposure to SARS-CoV-2. The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.
Op-T LLC
This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts.
Sunnybrook Health Sciences Centre
This study is a 12-month, four-arm parallel-group randomized control trial of Pfizer-BioNTech versus MODERNA COVID-19 (Corona Virus disease 2019)vaccine boosters in chronic kidney disease and dialysis patients with poor humoral response following COVID-19 vaccination, in collaboration with 5 dialysis centers in Ontario and British Columbia, Canada . Patients will be randomized to MODERNA or Pfizer-BioNTech COVID-19 vaccine, they may have received either MODERNA or Pfizer-BioNTech COVID-19 vaccine for their initial two doses of vaccine, and will be stratified by their initial vaccine type (MODERNA or Pfizer-BioNTech ) prior to randomization, which will result in four study groups.
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.
Azienda Sanitaria-Universitaria Integrata di Udine
Hypoxemic acute respiratory failure is one of the main COVID-19 patients complication that lead to in intensive care hospitalization. This complication determines a variable mortality from 25 to 30%. To correct hypoxemia (often severe) is often needed non-invasive or invasive mechanical ventilation. Mechanical ventilation is not a therapeutic strategy, but it allows to extend the time-to-recovery necessary to solve COVID-19 respiratory failure cause. Calibration of ventilatory support is essential to ensure adequate time-to-recovery without contributing to onset lung and / or diaphragmatic damage. Basal diaphragmatic activity assessment, device for administering the oxygenation support choice and setting ventilatory support parameters are decisive. Ultrasound is the best method for measuring diaphragmatic work. The aim of this study is to evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted to Intensive Care Unit (ICU) for acute respiratory failure and to record its function on weaning.
GI Alliance
The aim of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with IBD who received a COVID-19 vaccine.
TCU and UNTHSC School of Medicine
To explore the efficacy of treatment of pulmonary cytokine storm induced by SARS-CoV2 with a monoclonal antibody to IL-2 (Basiliximab) in addition to current standard of care vs current standard of care with the primary efficacy endpoint being the proportion of subjects alive and free of ventilator support, defined as intubation and requiring mechanical ventilation, at Day 28 from time of randomization.