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.
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.
To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.Displaying 50 of 2820
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
The COVID-19 pandemic health crisis forces health institutions to lower their standards of protection as supplies of personal protective equipment decrease despite the safety of front-line workers worldwide . This shortage specifically affects high-quality protective masks, such as those called FFP2. As alternatives, we offer a reusable mask based on a ventilation mask combined with a breathing filter for anesthesia breathing circuits. The purpose of the study is to assess the sealing potential of this mask in the field and possibly prove a non-inferior sealing compared to standard masks type FFP2.
University Of Perugia
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.
University Hospital, Strasbourg, France
Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. When Acute respiratory failure is caused by pathology of the pulmonary parenchyma, quantification of pulmonary radiographic involvement may be a component of the initial assessment of severity. This radiographic quantification would only be usable in clinical routine if it can be automated and provide a real-time result. The objective of this work is to assess the feasibility of an automated technique for quantifying radiological lung damage in situations of known or potential ARF.
Versailles Hospital, Bernard LIVAREK, MD, Cardiology department, Versailles Hospital, Jean-Paul BERESSI, MD, Department of diabetology, Versailles Hospital, Mehrsa KOUKABI FRADELIZZI, MD, Emergency department, Versailles Hospital, Floriane GILLES, MD, Cardiology department, Versailles Hospital, Alisson BERTRAND, Cardiology department, Versailles Hospital, Marie DE TOURNEMIRE, Cardiology department, Versailles Hospital, Victorien MONGUILLON, Cardiology department, Versailles Hospital, Maeva PASQUALINI, Cardiology department, Versailles Hospital, Alix PREVOT, Cardiology department, Versailles Hospital, Guillaume ROGER, Cardiology department, Versailles Hospital, Joseph SABA, Cardiology department, Versailles Hospital, Joséphine SOLTANI, Cardiology department, Versailles Hospital, Jean-François PROST, Cardiology department, Versailles Hospital, Cécile LAUREANA, Department of medical information, Versailles Hospital
Background. Angiotensing converting enzyme type 2 (ACE2), a key enzyme of the renin-angiotensin-aldosterone system (RAAS), is the receptor of SARS-CoV-2 for cell entry into lungs. Because ACE2 may be modulated by RAAS inhibitors, such as angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), there is concern that patients treated with ACEi and ARBs may be at higher risk for COVID-19 infection and severity. Aim. To analyze the associations between COVID-19 and hypertension, and treatments with ACEi and ARBs. Methods. In this retrospective observational study, consecutive patients hospitalized for suspected COVID-19 pneumonia will be divided into 2 groups, whether or not COVID-19 is confirmed. The two groups will be compared for baseline characteristics, mainly prior treatment with ACEi and ARBs, and clinical outcome at 1-month follow-up. The main hypothesis is that ACEi and ARBs, which interact differently with ACE2, may have different relationships with COVID-19 infection or severity.
University Hospital, Toulouse
To date, the effects of SARS-Cov-2 (Covid-19) on the myocardium and the role it plays in the evolution towards an acute myocarditis are badly understood. The current pandemic of this emerging virus is an opportunity to assess the proportion of acute myocarditis attributable to SARS-Cov-2(Covid-19) and to assess the clinical, biological and imaging presentations, by means of a national prospective multicentre hospital registry of cases of acute myocarditis.
King Hussein Cancer Center
COVID-19 caused an unprecedented international crisis. There is an urgent need for an effective regimen to cure this illness. Anecdotal data and some prospective results suggested a role of antimalarial drugs (chloroquine and hydroxychloroquine) in the treatment of this disease with best available data showing value of adding azithromycin. Based on drug repurposing studies done by our team and others, we identified the autophagy/apoptosis pathway as a major target for intervention. Based on in-silico and in-vitro models, sirolimus was identified as the drug that deserves urgent prioritization. The rational for combining sirolimus and hydroxychloroquine is explained in details in the study background below and a short video prepared by study PI (https://youtu.be/-zlOMXJp2hg). The evidence for using sirolimus for influenza is emphasized by a RCT that showed reduction of mechanical ventilation time by 50% (7 days on sirolimus arm vs 15 days on oseltamivir/steroids arm). Safe administration in human subjects is illustrated by multiple phase I/II clinical trials, performed in patients with cancer. COVID19-HOPE trial will randomize patients to 2 arms: HCQ/AZ (Arm A) and HCQ/SIR (Arm B). The main inclusion criteria is an RT-PCR test confirming infection with SARS-CoV-2 along with objective clinical criteria of disease (fever, tachypnea and/or hypoxemia). The primary endpoint of study will be Time To Clinical Improvement (TTCI), defined as time from randomization to resolution of the clinical features mentioned above (no fever, no tachypnea and no hypoxemia). In addition, secondary endpoints will include clinical failure by day 28 (need for intubation and/or death), QT interval prolongation, and adverse events. The estimated NNT based on Wilcoxon Mann Whitney comparison of TTCI in study arms is 58 patients (29 each arm). The study includes an adaptive plan, meaning that after different time points the study results will be evaluated and the NNT and randomization scheme (1:1 vs. others) will be evaluated and submitted to the IRB. Also, if one arm proves to be of no value, another regimen might be introduced based on available data. The study will recruit patients for a year and once approved by IRB and JFDA attempts to recruit other centers will be made (including national and regional centers).
This protocol will evaluate the efficacy of Therapeutic Plasma Exchange alone or in combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine release syndrome. It is hypothesized that dual intervention of acute apheretic depletion of cytokines and concomitant suppression of production will produce superior amelioration of the cytokine load and to help to prevent cytokine load rebound. This protocol is envisioned as a pilot study (n=20) for hypothesis generation for future investigation.
An Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe COVID-19 infection
Hospices Civils de Lyon
The COVID-19 pandemic is profoundly changing the way people live and work. After the health impact, it is the mental and psychological impact that reaches varying degrees in the entire world population. The previous Asian epidemics have had a lasting impact on the health professionals concerned. In France, no study has yet assessed the psychological impact of this health crisis on the level of health professionals. Investigators propose to study prospectively the evolution of the state of stress and anxiety of all the professionals practicing within the gynecology-obstetrics departments of 18 French hospitals. Investigators also hypothesize that the mental repercussions in terms of stress and anxiety within the same service could be different depending on the professional status and the place of exercise (the French regions being impacted in different ways). In addition to the epidemiological interest, the results of this study may help us to target regions and professionals who will need psychological support during and after this serious health crisis.
Vendsyssel Hospital, Aalborg University Hospital
During the COVID-19 pandemic after reopening of the country, school, kindergarten and daycare, children have been obligated to do frequent handwash. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare facilities electronic platforms.