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 20 of 25NeoImmune Tech
Lymphopenia is common in patients with COVID-19 and is associated with worse clinical outcomes. NT-I7 is a long-acting human interleukin-7 (IL-7) that has been shown to increase absolute lymphocyte count (ALC) and CD4+ and CD8+ T cell counts with a well-tolerated safety profile in humans. In this study, patients who have tested positive for SARS-CoV-2 by PCR testing without severe disease and with ALC
City of Hope Medical Center
Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.
Epicentre
The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.
Hellenic Society of Hematology
This is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.
Nordsjaellands Hospital
Prone position ventilation is frequently used in the ICU to treat severe hypoxemia in patients with COVID-19 associated acute respiratory distress syndrome (ARDS). The aim of the PROVENT-COVID study is to assess whether applying prone position ventilation immediately after intubation reduces the duration of mechanical ventilation compared to prone position ventilation according to standard criteria for prone position.
Kafrelsheikh University
Investigating the role of 13cis retinoic acid in the treatment of COVID-19 and enhancement of Its spike protein based vaccine efficacy and safety.
Derek Yellon
The coronavirus disease (COVID-19) emerged in late 2019 and has since been diagnosed in over a million persons worldwide. As this virus progresses, it causes an extreme and uncontrolled response from the patient's immune system accompanied by reduced oxygen flow to major organs, and subsequent ischaemic injury. The current treatment of COVID-19 is largely supportive without any cure or vaccine available at this time. Developing new methods to reduce this heightened inflammatory response is essential to halting progression of COVID-19 in patients and reducing the severity of damage. The cellular mechanisms seen in COVID-19 are similar to those seen in patients with sepsis. A process known as Remote Ischemic Conditioning (RIC) is an intervention which has been shown to prevent cellular injury including those associated with sepsis. Based on the evidence from studies looking at sepsis, it is anticipated the same benefit would be seen in patients diagnosed with COVID-19. RIC is a simple, non-invasive procedure where a blood pressure cuff is applied to the arm for repeated cycles of inflating and deflating (typically 3-5 cycles of 5 minutes each). This process activates pro-survival mechanisms in the body to protect vital organs and improve the immune system. Therefore, we believe it represents an exciting strategy to protect organs against reduced blood flow and extreme immune response, as seen in COVID-19 infections. This study has already been fully approved
Department of Health, Philippines
This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.
Faculty of Medicine , Kafrelshiekh University, Egypt.
Utilizing the crosstalk among aerosolized phenformin, methylene blue, photodynamic therapy , zinc and potassium for treating severe COVID-19 infection and its inflammatory complication Amr Ahmed(1), Mahmoud Elkazzaz(2), Tamer Haydara(3), and Abdullah Alkattan(4) 1. Director of tuberculosis program Ghubera, public health department ,First health cluster ,Ministry of health ,Saudia Arabia. 2. Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt. 3. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt. 4. Ministry of Health, Riyadh, Saudi Arabia. SARS-CoV-2 represents the largest current health challenge for the society. Moreover, numerous variants of the virus that causes COVID-19 are being tracked in the United States and globally during this pandemic. Here, we will use combination therapy which involve agents with significant activity and different mechanisms of action against covid-19 and its inflammatory complication. Excessive activities of cysteinyl cathepsins (CysCts) contribute to the progress of many diseases. however, therapeutic inhibition has been problematic. Cathepsin L are crucial in terms of the endocytosis by cleaving the spike protein, which permits viral membrane fusion with endosomal membrane, and succeeded by the releasing of viral genome to the host cell. Thereby, inhibition of cathepsin L may be advantageous in terms of decreasing infection caused by SARS-CoV-2. It is well known that zinc (Zn) possesses a variety of direct and indirect antiviral properties, which are realized through different mechanisms. Administration of Zn supplement has a potential to enhance antiviral immunity and to restore depleted immune cell function, in particular in immunocompromised patients. It has been found that Zn 2+ deficiency leads to an exaggerated activity of Cysteine cathepsin increasing the autoimmune/inflammatory response. . Zn2+ is a natural inhibitor of proteases with CysHis dyads or CysHis(Xaa) triads. cysteine protease Cathepsin L (CatL) involvement with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and COVID-19 from different points of view. At this purpose Zn 2+ metal can be safely combined with phenformin a drug that increases the anti-proteolytic effect of endogenous Zn 2+ lowering the excessive activity of some CysCts.; A study found that phenformin-Zn2+ complex is identified as a modifiable pharmacophore for synthesis of therapeutic CysCt inhibitors with a wide range of potencies and specificities. Phenformin stabilizes a "Zn2+ sandwich" between the drug and protease active site. Additionally, phenformin was found to be potent inhibitor of IL-6 R, with phenformin (100 µM) treatment for 48 h, decreased IL-6R expression in ANBL6, RPMI, U266, MM1S, and JJN3 was 5.51 (p = 0.0025), 3.03 (p = 0.0005), 1.55 (p < 0.05), 2.09 (p = 0.0082) and 1.19-fold, respectively. Furthermore, phenformin was discovered to potentially and strongly bind to ACE2 receptors, according to a docking research being conducted by the principle investigators of this clinical study therefore, Phenformin is expected to potentially attach to ACE2 receptors and lead to its downregulation, an inhibitory mechanism which may combat and block COVID-19 infection in lung epithelial cells. Phenformin may induce lactic acidosis therefore according to the principal investigator The phenformin will be utilized as aerosolized by inhalation for COVID-19 treatment and this may be an effective novel treatment strategy that would limit the risk of systemic side-effects associated with biguanides due to the low inhaled dose. In addition, we will use aerosolized phenformin in combination with methylene blue. A study found that a very marked improvement in lactate and pyruvate concentrations occurred within six hours of the beginning of méthylène blue administration in human . It has been known for some time that méthylène blue is a moderately efficient hydrogen acceptor in several enzyme sys¬ tems and significantly reduce oxidative stress by scavenging ROS. Moreover, Methylene Blue has antiviral activity and was found to Inhibit the Spike-ACE2 Protein-Protein Interaction-a Mechanism that can contribute to its Antiviral Activity Against COVID-19 For many reasons, methylene blue is a promising drug for an active treatment against SARS-CoV-2 . Since methylene blue can work as a photosensitizer, photodynamic therapy as an antiviral treatment has great potential in the treatment of COVID-19.. This clinical study will investigate the effectiveness of SARS-CoV-2 infected people treatment using methylene blue and the following photodynamic therapy after that our clinically approved patients will receive phenformin and zinc . But methylene blue may lead to lowering in potassium concentration.Therefore, we will add potassium supplement to this combination.
M.D. Anderson Cancer Center
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.