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 280 of 895Diffusion Pharmaceuticals Inc
This study will assess the safety and efficacy of TSC as a treatment for participants who are infected with SARS-CoV-2 (COVID-19).
Sanofi
Primary Objective: To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with primary Sjögren's syndrome (pSjS), assessed by the change of the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) Secondary Objectives: - To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the therapeutic efficacy on fatigue of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 12 weeks in adult patients with pSjS - To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo in adult patients with pSjS as determined by adverse events (AEs) - To evaluate the local tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS determined by electrocardiogram, vital signs, and laboratory evaluations - To measure the immunogenicity of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS This is a multicenter, randomized, double blind, placebo controlled, parallel group proof of concept Phase 2 study to evaluate the therapeutic efficacy of SAR441344 in adult patients with primary Sjögren's syndrome (pSjS), as well as safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). - Study visit frequency: every 2 weeks in the treatment period and every 4 weeks in the follow-up period. - The total duration of the study will be 24 weeks (28 weeks including maximum screening duration) for each participant, including a 12-week treatment period and a 12-week follow-up period.
Unidad Temporal COVID-19 en Centro Citibanamex
Introduction: SARS-CoV2 infection produces severe pneumonia with pulmonary alveolar collapse. There is no specific treatment to date. In experimental models and humans with septic shock, there is a high production of nitric oxide (NO) and reactive nitrogen species (RNS) and can cause multiple organ failure. The administration of antioxidants such as n-acetylcysteine (NAC), vitamin C, melatonin, and vitamin E participate in increasing the intracellular content of GSH, ROS sequestration, protection of the lipids of cell membranes, cytosol proteins, nuclear DNA, mitochondrial and decrease LPO. Justification: as there is no specific antiviral therapy, the therapeutic options are limited, complications and mortality are high; It is intended to evaluate the effect of antioxidants on the storm outcome of the dysregulation of oxidative stress. Hypothesis: It is postulated that adjuvant therapy with antioxidants and Pentoxifylline reduces the use of ventilators in patients with or without septic shock secondary to severe SARS-COV2 pneumonia as decreases lipoperoxidation, and corrects dysregulation of oxidative stress by increasing the antioxidant capacity. Objectives: To evaluate whether it is possible to avoid intubation or decrease assisted mechanical ventilation days, improve oxidative stress dysregulation in patients with SARS-COV2 infection with severe pneumonia with or without septic shock. Methodology: Quasi-experimental, open analytical, prospective, and longitudinal study (before-after). In patients over 18 years of age who are admitted to the CITIBANAMEX Center with or without septic shock secondary to severe SARS-COV2 pneumonia. There will be two groups: 1) patients without septic shock and 2) patients with septic shock secondary to severe pneumonia due to SARS-COV2. A single antioxidant will be applied following the clinical decision tree (NAC, Vit C, Vit E, melatonin) more Pentoxifylline orally or by orogastric tube for a total of 5 days from the start of the protocol. APACHE II will calculate the risk, SOFA, MEXSOFA, measurements of IL-8, vitamin C, NO3 / NO2, LOP, total antioxidant capacity will be carried out at baseline and 48 hours. SOFA will be calculated for seven days, in addition to days of hospitalization, days of mechanical ventilation. It was evaluated 28 days after discharge by telephone.
University of Giessen
To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.
Stanford University
The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants. The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.
Pharmamel S.L.
There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.
Iqvia Pty Ltd
The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.
Azienda Ospedaliera "Sant'Andrea"
SARS-CoV-2 infection is a condition characterized by excessive leukocyte infiltration, massive release of chemokines, proteases and cytokines, the so-called "cytokine storm", which promote the inflammatory process and contribute to exacerbation of COVID-19 symptomatology. Because of the abnormal release of pro-inflammatory cytokines by non-neuronal cells of the immune system, such as the mast cells in periphery, and microglia at central level, the body activates a defensive neuroinflammatory process that, if not controlled, can become pathological. Therefore it's important to intervene early on neuroinflammation, in order to limit the progression of the disease. A possible intervention is represented by Palmitoylethanolamide (PEA), an endogenous molecule of the N-acylethanolamine family synthesized "on demand" in response to "stress factors" to restore tissue homeostasis, able to control mast cells and microglia uncontrolled activation. Experimental evidence in vitro and in vivo demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultra-micronized PEA (mPEA and umPEA), confirmed in various clinical investigations conducted in patients with different pathological conditions. The aim of this study is to investigate the efficacy of a compound containing mPEA + umPEA on peripheral inflammatory markers, neuroinflammation, and others clinical parameters in intensive care patients with COVID-19 interstitial pneumonia.
Sociedad Argentina de Reumatologia
SAR-COVID is a national, multicenter, prospective, observational longitudinal registry of consecutive patients with diagnosis of rheumatic diseases treated or not with immunomodulatory and/or immunosuppressive drugs and SARS-CoV-2 infection (asymptomatic or COVID-19). Hypothesis: Patients with rheumatic diseases who are under chronic treatment with immunomodulatory and/or immunosuppressive drugs more frequently have an asymptomatic infection, a milder COVID-19 and lower mortality than patients with rheumatic diseases without immunomodulatory and/or immunosuppressive treatments.
University of the Philippines
This protocol provides access to investigational convalescent plasma for hospitalized patients with COVID-19. Following provision of informed consent, patients will be administered around 500 mL of convalescent plasma obtained from an individual who has recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety outcomes include serious adverse events judged to be related to convalescent plasma. Other information which will be collected includes patient demographics and clinical data which includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and 28-day mortality.