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 90 of 360Biontech SE
This trial has two parts. Part A and Part B. Due to changes in the overall clinical development plan, Part B will no longer be conducted. The objectives originally described for Part B have been implemented in the ongoing development via a pivotal Phase I/II/III trial BNT162-02/C4591001 (ClinicalTrials.gov NCT: 04368728). Part A is for dose ranging of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2) which will be undertaken with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older participants. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen. Three additional cohorts aged from 18 to 85 years receiving BNT162b2 only. BNT162b2 has entered a Phase II/III evaluation of efficacy, with the intent to support an application for marketing authorization. The dosing regimen under investigation is two BNT162b2 doses given ~21 d apart.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods.
Fondation Ophtalmologique Adolphe de Rothschild
The management of patients with SARS-CoV2 in respiratory distress can expose to corneal or retinal lesions induced by the stay in intensive care. Examination by ophthalmologists would make it possible to detect the most of the ophthalmologic problems known in intensive care and to provide an early, preventive or curative therapeutic response when possible, in order to avoid irreversible visual loss. The object of the research is to assess the presence and the importance of surface ophthalmologic lesions, the presence and the importance of retinal or optic nerve lesions, in order to improve the monitoring and primary prevention of this population
Belarusian State Medical University
Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Egyptian Center for Research and Regenerative Medicine
The medical and paramedical staff of the front-line services are potentially exposed to SARS-CoV-2. Therefore, despite the application of standard protective measures, it is possible that a certain number of these personnel have already contracted SARS-CoV-2, including in its asymptomatic form. Serological testing in this context would be useful for deploying immune healthcare workers as to limit the risk of viral infection and transmission. Therefore, it is of utmost importance to prove that the serological response entails the production of neutralizing antibodies.
Priscilla Hsue, MD
The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.
Takeda
So far little is very few drugs have demonstrated positive results for treatment of COVID19. Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent decrease in oxygen use. Yet the effect of the three dosages as according to the label dose was insufficient to maintain the clinical improvement in a small group of patients. The researchers argue that with the use of lanadelumab a more lasting effect can be reached due to its longer half life.
Imperial College London
To determine whether the coagulopathy associated with COVID-19 infection is driven by overactivation of the renin angiotensin system (RAS)
Barking, Havering and Redbridge University Hospitals NHS Trust
NLR has previously been observed to correlate with complications in upper GI (1) and colorectal (2) surgery. The investigators sought to assess if a similar correlation can be identified in emergency general surgical patients and if the presence of suspected or confirmed COVID-19 may impact on this. Given the heterogeneity of emergency general surgery the investigators therefore plan to perform a retrospective review of patients having emergency laparotomies only at a single NHS site during COVID-19 pandemic. Assessment of outcomes and Neutrophil:lymphocyte ratio as a predictor of outcomes will be completed. Outcomes will be completed in line with the recent COVIDSurg study criteria (3). The primary outcome is 30-day mortality. Secondary outcomes are 7-day mortality, re-operation, length of stay, post-operative respiratory failure, post-operative ARDS (Acute Respiratory Distress Syndrome), post-operative sepsis and ITU (Intensive Therapy Unit)/HDU (High Dependency Unit) admission.
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.