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 160 of 515Aferetica
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. The use of solutions enriched of antiviral antibodies has several important advantages over the convalescent plasma including the high level of neutralizing antibodies supplied. Moreover, plasma-exchange is expensive and requires large volumes of substitution fluid With either albumin or fresh frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia. The use of plasma as a substitution fluid further increases treatment costs and is associated with risk of infections, allergic reactions and citrate-induced hypocalcemia. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. The aforementioned limitations of plasma therapy can be in part overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP)3. During DFPP, plasma is separated from cellular components by a plasma filter, and is then allowed to pass through a fractionator filter. Depending on the membrane cut-off, the fractionator filter retains larger molecules and returns fluid along with smaller molecules to the circulation. Thus, the selection of a membrane with an appropriate sieving coefficient for IgG allows to efficiently clear autoantibodies in patients with antibody-mediated diseases (e.g., macroglobulinemia, myasthenia gravis and rheumatoid arthritis) with negligible fluid losses and limited removal of albumin and coagulation factors1. In patients with severe membranous nephropathy and high titer of autoreactive, nephritogenic antibodies against the podocyte-expressed M type phospholipase A2 receptor (PLA2R), DFPP accelerated anti PLA2R depletion4. Measurement of the antibody titer in treated patient and recovered fluid showed that antibody removal was extremely effective and that large part of antibodies was removed during the first DFPP procedure. This therapeutic regimen was safe and well tolerated and easy to apply4. In an ongoing pilot study we found that the same methodological approach can be used to remove circulating antibodies from patients who recovered from COVID 19 and to infuse these antibodies in patients with active viral infection. Treatment was well tolerated and preliminary findings are encouraging. Thus, in this novel pilot study we aim to explore whether the infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent donors could offer an effective and safe therapeutic option for patients with earlier stages of coronavirus (COVID-19) pneumonia requiring oxygen supply without mechanical ventilation.
Centre Hospitalier Princesse Grace
To date no treatment has proven its effectiveness in the caring of patients infected with type 2 Coronavirus. The Centre Hospitalier Princesse Grace (CHPG) has decided to only propose randomized double-blind placebo-controlled clinical trials to patients at the early and symptomatic stages of the disease. Data from the literature show in vitro results on the potential clinical benefit of some treatments such as chloroquine or hydroxychloroquine (HXCQ). Observational data suggest a potential benefit of this treatment alone or in combination with azithromycin (HXCQ + AZ). These data were advertised or led to a request from ambulatory medicine and patients to have access to these treatments despite their poor level of evidence. This leads to a decrease in the number of patients recruitable for clinical trials because they refuse the concept of control arms or they wish active treatment (CQ, HXCQ or HXCQ + AZ) from the start. In this context, we propose to conduct in parallel with randomized trials, a so-called "patient preference" protocol which, after patients information, gives them the choice, either to participate in the trial or to choose between treatment with HXCQ, treatment with HXCQ + AZ or standard of care without medication. The patients follow-up and the main endpoint will be the same under the patient preference protocol as for the randomized trial. The advantage of this approach is to offer a common follow-up to all patients, to take into account patients who refuse to participate in the clinical trial, to obtain external validity data, to reduce selection bias and to increase the heterogeneity of patients exposed to treatment options. The expected objective is to see if the patient preference protocol leads to observe the same effects as in the randomized trial.
Centre Hospitalier Universitaire de Nīmes
The study hypothesis is that low-dose computed tomography (LDCT) coupled with artificial intelligence by deep learning would generate imaging biomarkers linked to the patient's short- and medium-term prognosis. The purpose of this study is to rapidly make available an early decision-making tool (from the first hospital consultation of the patient with symptoms related to SARS-CoV-2) based on the integration of several biomarkers (clinical, biological, imaging by thoracic scanner) allowing both personalized medicine and better anticipation of the patient's evolution in terms of care organization.
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.
Cairo University
Until now there is no vaccine or reliable treatment for the COVID-19 pandemic. The fundamental mechanisms of non-invasive low-level laser in photobiomodulation (PBM) and photodynamic therapy is to stimulate the mitochondrial respiratory chain where a transient release of non-cytotoxic levels of reactive oxygen species (ROS) will lead to positive modulation of the immune response. As previous studies mentioned that the most important strategy for COVID-19 management is oxygenation and faster rehabilitation of the damaged tissue, antiviral effects, and, finally, reduction or controlling the cytokine storm by reducing inflammatory agents. PBM may be used as adjuvant therapy or even an alternative therapy in all these mechanisms without side effects and drug interactions. Objectives The objective of this clinical trial is to use the photobiomodulation therapy (PBMT), and photodynamic therapy as adjuvant therapy or even an alternative therapy for Covide-19. Patients and methods A randomized controlled study will be conducted on 60 patients of positive COVID 19. The patients will be divided into 3 equal groups. Group, I will receive a low-level laser (diode laser 980nm) from laser watch for 30 minutes, 20 J for 3 to 5 days, and laser acupuncture. Group 2 will be treated with photodynamic therapy by injecting the methylene blue as a photosensitizer and irradiated with laser watch (diode laser 670 nm). Group 3 will serve as a control. Evaluation methods will include laboratory investigations and CT chest.
Centre Hospitalier Intercommunal Creteil
France and in particular the paris area was one of the countries most affected by the pandemic Covid19. School closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2 viruses by PCR and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with SARS-CoV2. The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status (IgM and IgG) after return to the community are crucial information to evaluate the speed of spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE study.
Imperial College London
Study rationale 1. An increasing proportion of the worldwide population is being infected with COVID-19. 2. There are ongoing and currently unanswered safety concerns about the effects of COVID-19 on reproductive health. 3. It will be immensely reassuring to rapidly report that COVID-19 has no detectable effects on male endocrine or sperm function. Conversely, if COVID-19 does impair male reproductive health, appropriate screening can be performed in couples trying to conceive, and further research can be undertaken. 4. The proposed study will be simple, rapid, and authoritative for the UK and worldwide.
Canadian Cancer Trials Group
The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
Janssen Scientific Affairs, LLC
This phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.
Farmoquimica S.A.
The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.