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 20 of 75Anhui 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.
National Institute of Allergy and Infectious Diseases (NIAID)
Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknownto date. It has been reported that coronaviruses cause direct central nervous systeminfection (Needham et al. 2020). Besides that, new or worsening cognitive impairmentcommonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey &Needham. 2020). The purpose of our study is to search and describe the cognitive andpsychiatric long-term consequences of COVID-19 on patients who have been discharged fromcritical care units. This is an ambidirectional cohort study, that attempts to followadults discharged from critical Care Units Adults due to COVID-19 up to 12 months afterdischarge, to evaluate the presence of cognitive impairment, linguistic and phonationfunction, depression, fatigue, functional gastroenterological symptoms, anxiety, or posttraumatic disorder, and performance in activities of daily living and physical responseto exercise as well.
University of Arizona
Viruses are a major health problem for the general public and at risk populations.Normally, detection of antibody titers is the gold standard for determining theeffectiveness of the immune system following natural or vaccine caused immunization.However, determining the effectiveness of other parts of the immune system are lesscommon due to the difficulties with testing. Furthermore, there is a critical need toaddress other therapies in case vaccination is not successful in immuncompromisedpopulations. Exercise has been shown to increase the strength of the immune systemagainst many types of viruses and therefore could be simple way to improve immunityagainst the COVID-19 virus. The aim of this research is to determine the effects ofexercise on anti-viral immunity against many types of common viruses before and aftervaccination. We hypothesize that exercise will enhance the anti-viral immunity before andafter vaccination.Up to 30 healthy volunteers (age 18-44 years) will be recruited to participate in thisstudy. For completion of Aim 1, three visits are needed totaling around 7 hours of thepatient's time and for Aim 2, three visits are needed totaling around 4.5 hours of thepatient's time. The initial visit will be for pre-screening and if deemed healthy enoughto participate, an exercise test to determine the VO2 max of the participant will beconducted. The following visits will require a trained phlebotomist to insert anin-dwelling catheter and participants will undergo a 20-minute incremental exercisetrial. Approximately 50mL of blood will be collected at four different timepoints: atrest, 60% VO2 max, 80% VO2 max, and 1-hr post-exercise. All four collected blood sampleswill be used to expand viral specific T-cells and compare IFN-γ rele
Beijing 302 Hospital
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic sinceoutbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk ofmortality and morbidity due to COVID-19. Despite there is a large number of clinicaltrials of COVID-19 vaccines, only a few participants with chronic liver diseases wereincluded.
Beijing 302 Hospital
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic sinceoutbreak in 2020. Patients with cancers may be at higher risk than those without cancerfor coronavirus disease 2019 (COVID-19). At present, limited data are available on thesafety and immunogenicity of COVID-19 vaccination for patients with cancer.
Samia Hassan El-Shishtawy
Evaluation of the efficacy of the AstrazenicaCovid 19 vaccine to develop IgG antibody andits level based on th12 weeks program. Also to follow the changes of markers ofcoagulation (D-dimer) after vaccination compared to the basic level. A cardiologyconsultant will follow D-Dimer results to be managed properly if there is a need. As itis expected to receive Sinopharm vaccine there will be comparison between results of thetwo types of vaccine. To our knowledge this will be the first study done on Egyptianpopulation.
GI Alliance
The aim of this study is to determine the impact of systemic immunosuppression onsustained antibody COVID-19 concentrations in patients with IBD who received a COVID-19vaccine.
National Natural Science Foundation of China
The study is designed to assess whether allergic rhinitis and allergen immunotherapyaffect the humoral response to SARS-CoV-2 Vaccination in adults. This is a prospectivestudy enrolling a total of approximately 120 subjects, 18-55 years old.
The Second Affiliated Hospital of Chongqing Medical University
On 11 February 2020, the International Committee for the Classification of Viruses namedthe disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia(coronavirus disease 2019, COVID-19). Due to the characteristics of livermicrocirculation disturbance and immune function disorder in patients with chronic liverdiseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, livercancer, etc.), those patients has a higher risk of infection than the general populationduring the epidemic period. More attention should be paid to personal protection anddisease prevention. Vaccination of COVID-19 vaccine can effectively prevent COVID-19virus infection and delay or prevent patients from developing into critical illness andreduce mortality. To evaluate the safety and effectiveness of COVID-19 vaccine in thosepatients with chronic liver diseases, and to guide the COVID-19 vaccination morescientifically, reasonably and effectively, this study was carried out.
Fundación Huésped
A randomized, double-blind, placebo -controlled, phase IIb clinical trial to evaluate theefficacy, safety and immunogenicity of one or two doses of Recombinant Novel CoronavirusVaccine (Adenovirus Type 5 Vector) in adults 18 years of age and older, living with HIV,on stable treatment, and virologically suppressed for at least 6 monthsProtocol number: FH-58