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 240 of 893Assistance Publique Hopitaux De Marseille
COVID19-associated disease may have different clinical aspects classified in 3 stages. Some patients initially presenting with a non-hypoxemic viral pneumonia (stage 2a) may evolve toward a more severe stage 2b or 3 (acute respiratory distress syndrome, ARDS) around the 7th or 10th day of evolution, with a severe biological inflammatory syndrome (CRP>200 mg/l), and some times more severe complications such as acute renal insufficiency, consumptive coagulopathy or shock, requiring increasing oxygen therapy, ICU admission, invasive mechanical ventilation and possibly leading to death. This detrimental evolution is due to a host-derived "cytokine storm" with a great excess of circulating inflammatory cytokines. In animal models of ARDS complicating coronavirus or influenza virus infection, the cytokine storm has been linked to hyperactivation of the NLRP3 inflammasome. NLRP3 constitutes an intracellular protein platform which is responsible for caspase1 activation and processing of interleukin (IL)-1beta and IL-18 . IL-1b is a major proinflammatory cytokine which induces IL-6, whereas IL-18 is an inducer of interferon gamma (IFNg) production by Th-1 lymphocytes. A blood IL-1/IL-6 signature can be defined by increased neutrophilia and CRP concentrations, whereas an IL-18/IFNg signature is characterized by severe hyperferritinemia, consumptive coagulopathy and cytopenia. A majority of patients with COVID-19 infections seems to have an IL-1/IL-6 signature, evolving in the more severe forms toward an IL-18/IFNg signature, mimicking cytokine profiles observed in other inflammatory diseases such as Still's disease or hemophagocytic syndromes. In Still's disease, therapeutic inhibition of IL-1 or IL-6 has proven to be very efficient strategies. During hemophagocytic syndromes, inhibition of IFNg is effective in humans notably through blockade of its receptor signalization, using the JAK kinase inhibitor ruxolitinib. Following this strategy, we propose to use biological drugs currently available for inhibition of IL-1 (anakinra), IL-6 (tocilizumab) or IFNg signaling (ruxolitinib) in the severe forms of COVID19-associated disease. Our hypothesis is that IL-1, IL-6 or JAK kinase inhibition will allow: 1. to prevent stage 2b worsening and the need to be admitted in ICU, by decreasing oxygen-requirement and systemic inflammation 2. to improve stage 3 and extremely severe stage 3, allowing invasive mechanical ventilation weaning, improving multi-system organ dysfunction, leading to a faster ICU exit. We propose an open randomized therapeutic trial (1/1/1) on 216 patients with severe stage 2b and 3 of the disease
Cairo University
There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, remains the most important management strategy. Since its discovery, lactoferrin and its related peptides are mainly considered to be important non-specific host defense molecules against a broad range of viruses including SARS-CoV, which is closely related to SARS-CoV-2 that causes COVID-19. Lactoferrin has been found to experimentally inhibit viral entry in murine coronavirus, and human coronaviruses hCOV-NL63 and pseudotyped SARS-CoV. Besides reducing viral entry, lactoferrin can also suppress virus replication after the viral entry. Another major aspect of lactoferrin bioactivity relates to its immunomodulatory and anti-inflammatory functions. Current thinking suggests that mortality from COVID-19 is not simply due to viral infection but is a result of a cytokine storm associated with hyper-inflammation leading to acute respiratory distress and subsequent mortality. A cytokine profile in severe COVID-19 cases is characterized by increases in cytokines and acute phase reactants and ferritin. In this regard, lactoferrin was demonstrated to reduce IL-6, TNF a, and downregulate ferritin in experimental settings simulating sepsis. In this study, we aim to study the potential application of lactoferrin against SARS-CoV-2 and propose the possibility of using different doses of supplemental lactoferrin as a potential adjunct treatment for COVID-19.
Hospital San Carlos, Madrid
SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality. The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid clinical improvement (within the first week), as well as a reduced mortality (from around 30% to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of LD-RT for SARS-CoV-2.
Assistance Publique Hopitaux De Marseille
Background: The preventive containment measures implemented in the COVID-19 pandemic are not feasible in chronic hemodialysis patients (HD) who need to attend their dialysis sessions 3 times a week. HD patients display frequent comorbidities (such as diabetes and cardiovascular disease), and immune deficiency, which expose them to an increased risk of severe forms of COVID-19. They can be infected in their dialysis center despite the measures taken to limit this risk. Their caregivers are also at risk of infection if patients carry the virus. Dialysis centers face major organizational challenges in terms of patient and caregiver safety. Knowing the viral serological status of HD patients and caregivers, the proportion of asymptomatic forms, and the persistence and effectiveness of immunization over time would be of major interest for patient management and the organization of dialysis care. Research objectives: The primary objective of SeroCOVIDial is to assess the prevalence of SARS-COV2 seroconversion at inclusion (M0) in a cohort of HD patients, using the rapid serological test. Secondary Objectives : 1) assess the prevalence of SARS-COV2 seroconversion in dialysis caregivers at M0, using the same test; 2) assess the proportion of asymptomatic forms of COVID-19 in HD patients and in their caregivers; 3) compare the prevalence of seroconversion and the proportion of asymptomatic forms in HD patients according to their clinical characteristics and co-morbidities; 4) assess the prevalence of SARS-COV2 seroconversion in participants who had a documented COVID-19; 5) evaluate the spread of the epidemic and the kinetics of seroconversion in patients and caregivers by a second test performed at M3; 6) evaluate the predictive value of SARS-COV2 seroconversion at M0 on the risk of developing a symptomatic COVID-19 infection within 6 months, in patients and caregivers; 7) evaluate a posteriori the intrinsic diagnostic performances of the test in comparison with serological gold standards (ELISA and seroneutralization). Methods: Multicenter cohort study, carried out in 4 dialysis facilities in Aix-Marseille. Procedure: collection of clinical data and rapid serological tests carried out at M0 and M3, in patients and caregivers (a systematic screening for COVID-19 symptoms has been carried out in all HD patients in the 4 participating centers since the beginning of the pandemic in France). Number of participants: 800 eligible persons (561 HD patients, and 239 caregivers). Material tested: rapid Biosynex serological test on 1 drop of blood, and 1 tube of frozen serum for patients at M0 and M3. Clinical data will also be collected. Primary endpoint: prevalence of SARS-COV2 seroconversion in HD patients. Maximum duration of participation for each patient: 6 months. Duration of research: 6 months and 2 weeks (inclusions over 2 weeks).
Gyeongsang National University Hospital
In-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat in patients with COVID-19. This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult patients hospitalized with COVID-19 pneumonia.
Sanofi
Primary Objectives: - Part 1 - To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. - To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors. - Part 2 - To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab. - Part 3A - To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC - To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC - Part 3B - To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC - Part 4 - To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab. - To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab. Secondary Objectives: - Part 1 - To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. - To estimate the anti-tumor effects of SAR442720 with pembrolizumab. - Part 2 - To assess the safety profile of SAR442720 combined with pembrolizumab. - To assess other indicators of anti-tumor activity. - To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. - Part 3A - To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. - To estimate the anti-tumor effects of SAR442720 with adagrasib - Part 3B - To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC. - To assess other indicators of anti-tumor activity. - To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. - Part 4 - To assess the safety and tolerability of SAR442720 formulations with pembrolizumab - To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
Instituto de Investigación Marqués de Valdecilla
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.
Novartis
The treatment of COVID-19 severe acute respiratory syndrome with ruxolitinib 5 mg orally every 12 hours during 14 days would stop the disproportionate inflammatory response, causing a reduction in the proportion of patients who show a progression and worsening of the severe acute respiratory syndrome.
Health Ricerca e Sviluppo S.R.L.
COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing . In both cases, the causal link is coronavirus within the host response. The rationale of use of deep yoga breathing as adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory cytokines overproduction and contextual lowering of the sympathetic stress response as a first cause of sleep and late mental disorders which can increase the annual suicide rate. An easily breathing medical Yoga protocol has been developed to test a cost-effective care provision, training, contact tracing and mass efficacy testing.
Boehringer Ingelheim
COVID-19, the infectious disease caused by the novel coronavirus SARS-CoV-2, currently poses a global economic, social, political and medical challenge. The virus originated in December 2019 in Wuhan, China, and has spread rapidly around the world. Currently, European countries, including Austria, are severely affected.The most common computed tomographic changes in acute lung injury include bilateral and subpleural milk glass opacity, consolidation in lower lobes, or both. In the intermediate phase of the infection (4-14 days after the onset of symptoms) a so-called "crazy paving" may occur. The most prominent radiological changes occur around day 10, followed by gradual resolution, which begins two weeks after the onset of symptoms. Given the phylogenetic relationship between SARS-CoV-1 and SARS-CoV-2, the similar clinical course in severe cases and overlapping CT patterns in the acute setting, persistent radiological and pulmonary functional changes in survivors are conceivable. It is also conceivable that a proportion of survivors will develop progressive ILD, either due to viral or ventilator-induced alveolar damage, or both. Here, the investigators intend to investigate COVID-19 survivors through clinical examinations, functional lung examinations, HR-CT scans, and by determining the "immunofibrotic" pattern in peripheral mononuclear cells (PBMCs) 1, 3, and 6 months after discharge.