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 80 of 530Corporacion 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.
National Institute of Mental Health (NIMH)
People have had to make a lot of changes to their lives due to the COVID-19 healthcrisis. Most experts agree that social distancing and other safety measures have taken atoll on people s mental health. Amish and Mennonite communities often have largefamilies. They may have limited access to health care. Their lifestyle is based oninteraction and group events rather than technology. So people in Amish and Mennonitecommunities may experience the pandemic in their own special ways.Objective:To describe the relationship between stress related to the pandemic and self-ratedmeasures of mental health symptoms and distress among Amish and Mennonite people withbipolar disorder and related conditions, and their family members.Eligibility:Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083).Design:Participants will be mailed 4 surveys. One survey will ask about depression symptoms. Onesurvey will ask about mania symptoms. One survey will assess a broad range ofpsychological problems. One survey will assess the impact of COVID-19 on their mentalhealth. They will fill out the surveys 4 times over 24 months.The surveys will not include participants names, just codes. This will help protectprivacy.Data collected in 80-M-0083 will be used. This includes data about participants genes,medical conditions, and assessments.Participants will get an 800 number they can call to speak to the research team. They canalso write to the team if they prefer. Participants who wish will get referrals formental health services. Participation will last up to 24 months. There will be an optionfor recontact in the future.
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.
Sanofi
The purpose of this umbrella study is to evaluate isatuximab when combined with novelagents with or without dexamethasone in participants with relapsed or refractory myeloma.Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlledexperimental substudies. Substudies 04 and 05 are independent experimental substudies.
Op-T LLC
This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blindedstudy that will be conducted in 2 parts.
Centre Hospitalier de Cayenne
Multicenter observational study of diagnostic test validation (Research Involving theHuman Person, type 3) In addition to the diagnosis by the reference method(nasopharyngeal swab), the patient will be asked to provide a saliva sample via asalivary spit. The clinical circumstances of the diagnosis, the age of the patient, theassociated terrain (diabetes, immunodepression, pregnancy) will be noted. Thenasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining sampleswill be frozen and stored at the CRB before being sent to the University Hospital of Caenfor analysis and concordance verification.The expected benefits are:Possibility of repeating tests in the same person more easily due to the absence of painand thus reduce the barriers to diagnosis and screening.Possibility of self-sampling, which could simply be sent to the laboratory, which wouldrelieve the diagnostic sites that mobilize staff and require a fairly heavy organization.Avoid long waiting lines that can be an obstacle and lead to a renunciation of thediagnosis.