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.
Search Tips
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 740 of 799Kafrelsheikh University
Efficacy and safety of Drug combination therapy of Isotretinoin and some Anti fungal Drugs as A potential Aerosol therapy for COVID-19 : An innovative therapeutic approach The pandemic of COVID-19 which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has infected over 2,000,000 people causing over 150,000 deaths.It hasno currently approved treatments.. Airborne SARS-CoV-2 infections in humans initiate from the virus entering nasal and airway epithelial cells through binding to angiotensin-converting enzyme 2 (ACE2). TMPRSS2, a cellular protease that activates the SARS-CoV-2 spike protein, colocalizes with ACE2 and can prime SARS-CoV-2 fusion directly at the plasma membrane. In the lungs, SARS-CoV-2 infects type I and type II alveolar epithelial cells, as well as alveolar macrophages that are among the first producers of pro-inflammatory cytokines. As key components of the immediate antiviral response, type I interferons (here after referred to as IFNs) are crucial for restricting viral replication and spread, through autocrine and paracrine type I IFN receptor (IFNAR) signalling. However, minimal amounts of IFNs have been detected in the peripheral blood or lungs of patients with severe COVID-19 In a mouse model of SARS-CoV infection, local IFN responses in the lungs were delayed relative to peak viral replication, which impeded virus clearance and was associated with the development of CRS . SARS-CoV-2 ORF3b is a potent interferon inhebitor and antagonist Here, we review the molecular mechanisms by which Retinoic acid (isotretinoin) and antifungal drugs can cooperate to induce interferon in covid-19 infected patients A study reported that 13 Cis retinoic acid induced significant upregulation of toll-like receptor 3 resulting in an immune response to dsRNA intermediate which can be partially generated during CoV-2 replication . TLR3 sensitized by dsRNA and cascades of signaling pathways (Interferon-regulatory factor 1 (IRFs) and Nuclear factor-κB (NFκB) activation, respectively) are activated to produce type I interferons. The production of type I IFNs is important to enhance the release of antiviral proteins for the protection of uninfected cells. RA can be generated in multiple forms as all-trans, 9-cis,and 13-cis retinoic acid. A study reported that Retinoic acid induces directly the expression of two transcription factors, Stat1 and IRF-1 which play central roles in the IFN signal transduction. In addition, RA induces IFN-a synthesis, IFNs can serve as the first line of immune defense against viral infections. IFNs are very powerful cytokines, which play a key role in combatting pathogenic infections by controlling inflammation and immune response by directly inducing antipathogen molecular countermeasures. There are three classes of IFNs: type I, type II, and type III. Antifungal drug. Fluconazol or itraconazol can inhibit cytochrome P450 enzymes, especially cype 26 which control retinoic acid concentration into human cells enhance both isotretinoin effect and Concentrations in Target Tissues This in turn lead to hyper interferon induction and synthesis in case of COVID-19. Also a study demonstrated that isotretinoin can be given as aerosolized via inhalation rout without any damage in lung cells. Repeated high doses of 13 cis retinoic by inhalation resulted in moderate loss of body weight, but microscopic investigation of ten tissues including lung and oesophagus did not detect any significant aerosol-induced damage therefore inhaled isotretinoin might provide sufficient drug to the target cells in lung for efficacy while avoiding systemic toxicity. In conclusion,isotretinoin therapy has furthermore a proven anti-inflammatory, anti-platelet and fibrinolytic activities which may protect patients infected with covid-19 from widespread blood clots. From this point, we suggest that isotretinoin will be the immunity passport" in the context of COVID-19.
University of Baghdad
Assessment of the Effectiveness of Niclosamide as Add on Therapy to the Standard of care Measures in COVID-19 Management in a randomized controlled clinical trial
Provincial Government of Central Java, Indonesia
Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia
In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory, and radiological manifestations will be evaluated in treated patients compared with the control group.
Foresee Pharmaceuticals Co., Ltd.
This is a Phase 2/3, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of FP-025 in adult patients with severe to critical COVID 19 with associated ARDS.
Bayer
Niclosamide (2000 mg QD) and Camostate (600 mg QID) are expected to be safe and well-tolerated as a combination therapy and to show clinically beneficial for COVID-19 patients.
Colgate Palmolive
Subjects (125) will be randomized to one of five mouthrinses and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash. Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva will be used for RT-PCR detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex). Subjects will complete a short survey on the taste and experience of using the mouthwash. Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products. In the seven-day period between study visit one and study visit two, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are asked to carry out their typical oral hygiene regimen with the products they typically use. All subjects keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures. Subjects complete study visit two one week after the baseline visit during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse) will occur and blood samples collected. each subject will undergo a periodontal exam.
Fulcrum Therapeutics
The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study Sponsor hypothesize's that the early initiation of p38α/β inhibitor therapy in patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis based on older age and elevated systemic inflammation will reduce clinical deterioration including progression to respiratory failure and death. To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of losmapimod versus placebo in subjects 50 and older who are hospitalized with moderate COVID-19 disease.
University College Hospital Galway
The investigators present a randomised open label phase Ib/IIa trial of nebulised unfractionated heparin to evaluate the effect of nebulised unfractionated heparin on the procoagulant response in ICU patients with SARS-CoV-2 requiring advanced respiratory support. As this is one of the first studies of nebulised heparin in COVID 19 lung disease the investigators will assess safety as a co-primary outcome.
University of Oxford
The C-MORE study is prospective observational holistic longitudinal study which will characterise the prevalence of multi-organ injury among COVID-19 survivors post hospital discharge and assess its effects on quality of life, exercise tolerance and mental health.
Tanta University
The global escalation of COVID19 pandemic has put the health care system under pressure with urgent need for treatment. In the absence of vaccine and approved drug against SARS-COV2 over the past 6 months, the health authorities were obliged to re-purpose existing drugs to fight this pandemic.