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 20 of 57Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Low-dose radiotherapy treatment delivered to both lungs in patients with immune-related pneumonia following COVID-19 infection is backed up by biological and clinical bases that justify its use as a possible therapeutic option in these patients. This is a preliminary exploratory study (non-pharmacological interventional) to evaluate the feasibility and tolerability of low-dose radiotherapy treatment of SARS-Cov-2 immune-mediated pneumonia, for the subsequent implementation of a phase II study.This is a preliminary, monocentric, single-arm, interventional, non-pharmacological exploratory study. All enrolled patients will be treated with low-dose radiotherapy. Participants will undergo irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy (further details in the dedicated section).
Memorial Sloan Kettering Cancer Center
The researchers are doing this study to find out whether the study drug hydroxychloroquine can prevent infection with the COVID-19 virus, compared with placebo, in people who are receiving radiation therapy for their cancer. The placebo used in this study is a tablet that looks the same as the study drug and is taken in the same way, but it does not contain any active ingredients.
Grupo de Investigación Clínica en Oncología Radioterapia
Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients. Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.
University of Birmingham
CovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic. Centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. During the pilot study, investigators should enrol patients with confirmed diagnoses of: - Colorectal cancer - Oesophagogastric cancer As a rapid response study to the COVID-19 pandemic, included cancer types will evolve throughout the course of the CovidSurg-Cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.
Nordsjaellands Hospital
Prone position ventilation is frequently used in the ICU to treat severe hypoxemia in patients with COVID-19 associated acute respiratory distress syndrome (ARDS). The aim of the PROVENT-COVID study is to assess whether applying prone position ventilation immediately after intubation reduces the duration of mechanical ventilation compared to prone position ventilation according to standard criteria for prone position.
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery, specially vascular surgery. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care. The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project. This investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.
Fondation Ophtalmologique Adolphe de Rothschild
The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed. A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome. In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models. Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities. Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear. Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.
University Hospital Tuebingen
Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: Until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers
Brigitta G. Baumert
Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis
University of Roma La Sapienza
The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18