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 640 of 767UPECLIN HC FM Botucatu Unesp
Coronavirus 19 (COVID-19) is a viral respiratory disease that was identified in December 2019 after the first cases in China, spreading rapidly until reaching pandemic status, causing the collapse of numerous health systems and strong economic and social impact. By the end of April 2020, 3.08 million cases, and more than 214 thousand deaths were already recorded. The treatment so far has not been established and there are several clinical trials testing known drugs that have antiviral activity in vitro, due to the urgency that the global situation imposes. Medicines with specific actions can take years to be discovered, while a vaccine also takes a long time. Recently, it has been shown that the worsening of Coronavirus infection may be related to the formation of micro clots in blood vessels and anticoagulants have been used as adjuvants in the treatment. This study is justified by conducting a pilot study that showed an in vitro antiviral action (anti-COVID-19) of high molecular weight heparin. Methods: A phase I / II clinical trial will be conducted. 40 participants will be included in two arms. Participants allocated to Group 1 (control) will receive inhalation with 0.9% saline applied 4/4 hours, for 7 days. Participants allocated to Group 2 (intervention) will receive high molecular weight inhaled heparin (250ug / mL 0.9% SF), at a 4/4 hour dose, for 7 days. The outcomes of interest will be safety (absence of moderate or serious adverse events) and effectiveness (measured in a score of 7 points, with 1 absence of limitations and 7, death). Expected results: The development of a new therapeutic option for COVID-19 is expected, with the possibility of use in other serious coronavirus diseases, to be subsequently tested in phase III studies.
Sorrento Therapeutics, Inc.
Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
Beni-Suef University
Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.
Corvus Pharmaceuticals, Inc.
This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.
Sorrento Therapeutics, Inc.
This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.
Nepal Health Research Council
The purpose of this study is to investigate the clinical efficacy of Isoquercetin in preventing disease progression and symptoms improvement in mild-to-moderate hospitalised COVID-19 patients.
Regional Center for Disease Control and Prevention, Jordan
Protocol summary Title A Prospective, randomized, adaptive phase II/III clinical trial, controlled, open-label, chemoprevention, 3-arms, parallel, multi-centred, to A Prospective, randomized, clinical trial, controlled, open-label, 3-arms, parallel, multi-centred, chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19 Study Periods & Duration of Treatment Study Duration: 6 months Approval (IRB and regulatory bodies) 1 month Recruitment and follow-up: 3 months Analysis, report writing and submission of publications 1 month This study is a parallel study of one period with an expected duration of treatment (for each subject) of 28 days, Objectives - To evaluate if hydroxychloroquine with the proposed dose can provide potent chemoprophylaxis against the development of COVID-19 positive patients in subjects who had primary exposure to COVID-19 positive patients. - To measure the incidence of potential adverse drug reaction rates for giving hydroxychloroquine for prevention of COVID-19 amongst close contacts - To provide early analysis of results and redefine sample size accordingly. - identifying subjects most likely to benefit during the phase II and focusing recruitment efforts on them during phase III - stopping one arm or the whole trial at an early stage for success or lack of efficacy based on phase II study results Design Prospective, Randomized, open-label, three-arm, parallel, adaptive phase II/III controlled study in which subjects will be randomly assigned in a 1:1:1 ratio as per the following: Arm-1: hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose) hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5. Arm-2: hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose), then 200mg once daily on day 2,3, 4 and 5. Arm-3: No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of interest such as self isolation, good personal hygiene and good nutrition.
United Medical Specialties
Determine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.
Gadjah Mada University
Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.
University of Aarhus
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease that has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of April 1, 2020, there are 874.081 numbers of confirmed cases with 43.290 fatalities. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. Key markers implying a fatal outcome are acute respiratory distress syndrome (ARDS)-like disease with pronounced dyspnea, hypoxia and radiological changes in the lung. Senicapoc improves oxygenation and reduces fluid retention, inflammation, and bleeding in the lungs of mice with ARDS-like disease. In cells, there is an antiviral effect of senicapoc.