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 440 of 510Ruijin Hospital
In December 2019, a novel coronavirus infectious disease characterized by acute respiratory impairment due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan city of Hubei province in China. So far no specific antiviral therapy can be available for patients with SARS-CoV-2 infection. Although symptomatic and supportive care, even with mechanical ventilation or extracorporeal membrane oxygenation (ECMO), are strongly recommended for severe infected individuals, those with advancing age and co-morbidities such as diabetes and heart disease remain to be at high risk for adverse outcomes. This pilot clinical trial will be performed to explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in severe patients with novel coronavirus pneumonia (NCP).
Pontificia Universidad Catolica de Chile
The study will evaluate the efficacy, safety, and immunogenicity of two vaccination schedules of an inactivated vaccine against SARS-CoV-2 infection in adults. Two doses of the vaccine will be administered in a 0,14 and a 0,28-day schedule. Follow-up of safety and efficacy will be assessed for 12 months after the first dose. Immunogenicity will be studied in a subgroup of participants.
CureVac
The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants. The primary objective of the open-label phase of this trial is to evaluate safety in all participants ≥ 18 years of age remaining in the trial after unblinding.
Lawson 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.
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant will last for approximately 13 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM) separated by 21 days.
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.
Strados Labs, Inc.
Listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow and discharge patients from hospital. Of these, only auscultation routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD or severe asthma (or chronic heart failure) remains a major problem. The Strados System has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the clinical utility of the Strados System in enabling periodic recording and reviewing of breath sounds in patients with chronic respiratory diseases, either in the ICU, or in less continuously monitored settings, including after inpatient discharge.
Pfizer
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
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.