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 5 of 5Department of Health, Philippines
This is an open label randomized controlled clinical trial which was designed to confirmthe potential efficacy and safety of favipiravir in the management of patients with mildto moderate COVID-19 compared to best supportive care.
Faculty of Medicine , Kafrelshiekh University, Egypt.
Utilizing the crosstalk among aerosolized phenformin, methylene blue, photodynamictherapy , zinc and potassium for treating severe COVID-19 infection and its inflammatorycomplicationAmr 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 UnitedStates and globally during this pandemic. Here, we will use combination therapy whichinvolve agents with significant activity and different mechanisms of action againstcovid-19 and its inflammatory complication. Excessive activities of cysteinyl cathepsins(CysCts) contribute to the progress of many diseases. however, therapeutic inhibition hasbeen problematic. Cathepsin L are crucial in terms of the endocytosis by cleaving thespike protein, which permits viral membrane fusion with endosomal membrane, and succeededby the releasing of viral genome to the host cell. Thereby, inhibition of cathepsin L maybe advantageous in terms of decreasing infection caused by SARS-CoV-2. It is well knownthat zinc (Zn) possesses a variety of direct and indirect antiviral properties, which arerealized through different mechanisms. Administration of Zn supplement has a potential toenhance antiviral immunity and to restore depleted immune cell function, in particular inimmunocompromised patients. It has been found that Zn 2+ deficiency leads to anexaggerated activity of Cysteine cathepsin increasing the autoimmune/inflammatoryresponse. . Zn2+ is a natural inhibitor of proteases with CysHis dyads or CysHis(Xaa)triads. cysteine protease Cathepsin L (CatL) involvement with severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2) and COVID-19 from different points of view. At thispurpose Zn 2+ metal can be safely combined with phenformin a drug that increases theanti-proteolytic effect of endogenous Zn 2+ lowering the excessive activity of someCysCts.; A study found that phenformin-Zn2+ complex is identified as a modifiablepharmacophore for synthesis of therapeutic CysCt inhibitors with a wide range ofpotencies and specificities. Phenformin stabilizes a "Zn2+ sandwich" between the drug andprotease active site. Additionally, phenformin was found to be potent inhibitor of IL-6R, 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 topotentially and strongly bind to ACE2 receptors, according to a docking research beingconducted by the principle investigators of this clinical study therefore, Phenformin isexpected to potentially attach to ACE2 receptors and lead to its downregulation, aninhibitory mechanism which may combat and block COVID-19 infection in lung epithelialcells. Phenformin may induce lactic acidosis therefore according to the principalinvestigator The phenformin will be utilized as aerosolized by inhalation for COVID-19treatment and this may be an effective novel treatment strategy that would limit the riskof systemic side-effects associated with biguanides due to the low inhaled dose. Inaddition, we will use aerosolized phenformin in combination with methylene blue. A studyfound that a very marked improvement in lactate and pyruvate concentrations occurredwithin six hours of the beginning of méthylène blue administration in human . It has beenknown for some time that méthylène blue is a moderately efficient hydrogen acceptor inseveral enzyme sys¬ tems and significantly reduce oxidative stress by scavenging ROS.Moreover, Methylene Blue has antiviral activity and was found to Inhibit the Spike-ACE2Protein-Protein Interaction-a Mechanism that can contribute to its Antiviral ActivityAgainst COVID-19 For many reasons, methylene blue is a promising drug for an activetreatment against SARS-CoV-2 . Since methylene blue can work as a photosensitizer,photodynamic therapy as an antiviral treatment has great potential in the treatment ofCOVID-19.. This clinical study will investigate the effectiveness of SARS-CoV-2 infectedpeople treatment using methylene blue and the following photodynamic therapy after thatour clinically approved patients will receive phenformin and zinc . But methylene bluemay lead to lowering in potassium concentration.Therefore, we will add potassiumsupplement to this combination.
Kafrelsheikh University
Investigating the role of 13cis retinoic acid in the treatment of COVID-19 andenhancement of Its spike protein based vaccine efficacy and safety.
Biomed Industries, Inc.
This Phase 2/3 trial evaluates four treatment strategies for non-critically illhospitalized participants (not requiring ICU admission and/or mechanical ventilation)with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir withor without Dexamethasone.
Direction Centrale du Service de Santé des Armées
Several patients with hypoxaemic SARS-CoV2 pneumonia were able to benefit from hyperbaricoxygen treatment (HBOT) in China. In a clinical case published in the Chinese journal ofhyperbaric medicine, treatment with repeated HBO sessions prevented admission tointensive care unit with mechanical ventilation in a patient aged 69 who presented withsigns of respiratory decompensation. HBOT is the most powerful oxygenation modality inthe body today. HBOT can dramatically increase the amount of dissolved oxygen in theblood. HBOT not only promotes blood transport but also its tissue delivery. Furthermore,HBOT has specific immunomodulatory properties, both humoral and cellular, making itpossible, for example, to reduce the intensity of the inflammatory response and tostimulate antioxidant defenses by repeating sessions. A virucidal capacity of HBOT mightalso be involved. HBOT is generally regarded as safe with very few adverse events.Following this feedback, it is proposed in the context of crisis management related toSARS-CoV2 to assess the value of HBO treatment of patients with CoV2 pneumonia. Indeed,it seems essential to propose therapeutic strategies to limit the risk of respiratorydecompensation requiring admission to intensive care unit for patients with SARS-CoV2pneumonia.