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 470 of 518GeoVax, Inc.
This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine the safety and the optimal dose of the GEO-CM04S1 vaccine. The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel, study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single booster shot to assess the immune response measured by the fold-increase in antibody against SARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers.
Medicago
This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo. Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.
University Hospital, Bordeaux
The aim of this study is to assess the prevalence and arrhythmogenic role of occult myocardial scars on Cardiac Magnetic Resonance (CMR) in a population of patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization, as compared to a population of age- and sex-matched healthy volunteers.
Hospital de Clinicas de Porto Alegre
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. This study aims to investigate the safety and efficacy of intravenous infusion of natural killer cells patients with COVID-19.
Wladimir Szpirt
This Randomized Control Trial (RCT) proposes combination of extracorporeal cytokine removal by plasma exchange (PLEX) and additional infusion of convalescent plasma (CCP) collected from COVID-19 recovered individuals at the end of the PLEX procedure. The combination of cytokine removal by PLEX and CCP infusion is in onvestigators opinion more rational compared to CCP infusion alone and as such probably more effective in reducing the duration of mechanical ventilation, length of stay in the intensive care unit, and potentially also mortality.
University of Cologne
This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.
University of Cologne
This is the first-in-human phase 1/2a trial of the inhaled administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.
Longeveron Inc.
A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection.
Instituto de Investigación Hospital Universitario La Paz
This is a phase I/II clinical trial using adoptive cell therapy with NK cells or memory T cells in patients affected by COVID-19. Severe cases with COVID-19 present a dysregulated immune system with T cell lymphopenia, specially NK cells and memory T cells, and a hyper-inflammatory state. This clinical trial proposes the use of cell therapy for the treatment of patients with worse prognosis due to SARS-CoV-2 infection (those with pneumonia and/or lymphopenia). This is an innovative and a non-pharmacological intervention.
Kafrelsheikh University
Efficacy of Aerosol Combination Therapy of 13 Cis Retinoic Acid and Captopril for Treating Covid-19 Patients Via Indirect Inhibition of Transmembrane Protease, Serine 2 (TMPRSS2) Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has infected over 20,000,000 people causing over 700,000 deaths. It has no 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). Transmembrane protease, serine 2 (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. Transmembrane protease, serine 2 (TMPRSS2) is an androgen receptor signaling target gene and an androgen-regulated cell-surface serine protease expressed predominantly in prostate and lung epithelial cell. TMPRSS2 is normally expressed several folds higher in the prostate relative to any other human tissue, though the normal physiological function(s) remains unknown. A study found that dihydrotestosterone (DHT) s a potent activator of TMPRSS2.On the other hand, Feily et al noted that low-dose isotretinoin (0.5 mg/kg/day for 15-20 weeks) in PCO patients with moderate to severe nodulocystic acne resulted in significant decreases in levels of serum total testosterone, prolactin, and dihydrotestosterone A study demonstrated that 13- cis -Retinoic acid competitively and reversibly inhibits dihydrotestosterone. Therefore, we suggest that 13- cis -Retinoic acid will downregulate TMPRSS2 expression thorough temporary preventing the effect of dihydrotestosterone (DHT) on the activation of TMPRSS2 gene expression. ACE inhibitors and ARBs are commonly taken by heart patients to reduce blood pressure and to treat heart failure.Earlier studies had cautioned that this class of drugs could possibly increase the risk for the novel coronavirus, SARS-CoV-2, infection and elevate COVID-19 severity. There is conflicting observational evidence about the potential clinical impact of ACE inhibitors and ARBs on patients with COVID-19. Select preclinical investigations have raised concerns about their safety in patients with COVID-19. On the other hand, Preliminary data hypothesise that angiotensin-converting enzyme (ACE) inhibitors and renin-angiotensin- aldosterone system (RAAS) inhibitors could benefit patients with COVID-19 by decreasing acute lung damage and preventing angiotensin-II-mediated pulmonary inflammation. Here in our review, we use established and emerging evidence based on the findings of previous studies and researches to propose that ACE inhibitors may benefit patients with COVID-19 via attenuating and abolishing the effect of androgenic hormones on inducing the expression of Transmembrane protease, serine 2 (TMPRSS2), even though, at the same time, ACE inhibitors cause an increase in the human cell surface receptor protein ACE2 which the novel coronavirus uses to enter and infect cells. A study on hypertensive rats demonstrated that using ACE inhibitors(captopril) abolished and attenuated the effect of dihydrotestosterone (DHT). In this study RAS inhibition exhibited beneficial effects on androgen-induced obesity and abolished the androgen-mediated increase in blood pressure (BP) observed in this model of PCOS. (83 ± 1 vs 115 ± 3 mmHg, p