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 390 of 723Health and Medical Research Fund
Background: Patients with COVID-19 have a range of clinical spectrum from asymptomatic infection, mild illness, moderate infection requiring supplemental oxygen and severe infection requiring intensive care support. High flow nasal cannula (HFNC) oxygen therapy and noninvasive ventilation (NIV) may offer respiratory support to patients with COVID-19 complicated by acute hypoxemic respiratory failure if conventional oxygen therapy (COT) fails to maintain satisfactory oxygenation but whether these respiratory therapies would lead to airborne viral transmission is unknown. Aims: This study examines whether SARS-2 virus can be detected in small particles in the hospital isolation rooms in patients who receive a) HFNC, b) NIV via oronasal masks and c) conventional nasal cannula for respiratory failure. Method: A field test to be performed at the Prince of Wales hospital ward 12C single bed isolation room with 12 air changes/hr on patients (n=5 for each category of respiratory therapy) with confirmed COVID-19 who require treatment for respiratory failure with a) HFNC up to 60L/min, b) NIV via oronasal masks and c) conventional nasal cannula up to 5L/min of oxygen. While the patient is on respiratory support, we would position 3 stationary devices in the isolation room (one next to each side of the bed and another at the end of the bed) of the patient with confirmed COVID-19 infection, and sample the air for four hours continuously. Results & implications: If air sampling RTPCR and viral culture is positive, this would objectively confirm that HFNC and NIV require airborne precaution by healthcare workers during application.
Merck KGaA, Darmstadt, Germany
The study will evaluate the safety and efficacy of orally-administered M5049 in Coronavirus disease 2019 (COVID-19) pneumonia participants who are hospitalized but not on mechanical ventilation.
Coalition for Epidemic Preparedness Innovations
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
Boston Children's Hospital
The COVID-19 pandemic has disrupted anesthesia care all over the world. There remains very little data on current practice patterns and patient outcomes, particularly in anesthetized children. This is a prospective observational, multi-center study to investigate airway management related outcomes in children undergoing anesthesia during this pandemic. The investigators will compare the incidence of complications (particularly hypoxemia) in patients with COVID-19 to those who are COVID-19 negative during airway management. PAWS COVID-19 Registry https://is.gd/PEDICOVID19 Registration link https://is.gd/researchrequest
International Vaccine Institute
This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.
Kiniksa Pharmaceuticals, Ltd.
Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).
Tanta University
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19.
North Carolina Translational and Clinical Sciences Institute
This study will test and follow persons quarantined at home after testing positive for SARS-CoV-2 (COV) aged 18 years and older and their household members aged 1 year and older. The purpose of this research study is to understand how often COVID-19 (Coronavirus Disease 2019) spreads in the household when someone who tests positive for the virus self-isolates at home. The purpose of the extension part of the study is to help us understand long-term immunity to COVID-19. We are interested in how our immune system might still protect us from COVID-19 even after antibody levels decrease or are no longer detected. We are also interested in how immunity to COVID-19 is different in kids vs. adults.
Fundacion SEIMC-GESIDA
At present, no treatment has been approved for COVID-19. However, in light of the increased interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected patients due to its potential benefit, the Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) have initiated the controlled distribution of the drug. Tocilizumab is indeed proposed as a potential treatment for severe COVID-19 in Spain. Based on the positive results of tocilizumab in the treatment of COVID-19 patients and the experience of tocilizumab in inducing rapid reversal of CSS in other pathologies several clinical trials and observational studies are being conducted to assess the effectiveness and safety of tocilizumab in COVID-19 patients. Further studies with a large sample size are required to confirm the effectiveness of tocilizumab in patients with COVID-19 pneumonia. The need for the management of severe COVID-19 disease is imperative, and every effort should be made to collect relevant clinical outcomes. The aim of the present study is to evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia who are currently hospitalized or admitted to ICU by describing improvement of respiratory function and mortality rate. This large real-world cohort therefore provides a unique opportunity to study this potential medicine during the current emergency situation, and support the findings from other ongoing clinical trials and observational studies, such as the Roche-sponsored Phase III study that is planned to start early April.
Yale University
This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting.