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 2150 of 2254University of Pennsylvania
In order to safely and effectively reopen businesses and universities across the US, institutions will need to develop approaches to rapidly identify COVID-19 cases and manage their spread while balancing program effectiveness, feasibility, costs, and scalability. This study will evaluate the implementation of a COVID-19 screening program that coordinates several existing systems at the University of Pennsylvania including saliva-based viral testing.
Owlstone Ltd
The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting.
University of Palermo
In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. The diagnosis of SARS-COV-2 infection is made by direct detection by PCR of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab. However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab.
Parexel
In this first-in-humans dose escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs). The study is intended to enable future studies of AZD7442's efficacy in preventing and treating COVID-19.
Anahuac University
The disease caused by SARS-CoV-2, has derived a pandemic in which its evolution and complications depend on the immune capacity of the host. The virus has been characterized by presenting an inflammatory cascade, increased by the overproduction of proinflammatory cytokines, the decrease in metalloenzymes and also the rapid spread of the virus. There are several lines of treatment, however, nutritional treatment only considered a caloric intake. For this reason, this study will evaluate the evolution of patients with COVID-19 assisted by nutritional support system and the effect of this therapy in reducing complications and comorbidities. Research question: Will the nutritional support system reduce complications in stage III positive COVID-19 patients with comorbidities (type 2 DM, SAH, overweight / obesity with BMI
Assiut University
Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most commonly observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation (DIC) compared to 0.6% of survivors.
Janssen Vaccines & Prevention B.V.
The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (>=) 18 to less than or equal to (= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged >= 18 to = 65 years in good health with or without stable underlying conditions.
Prisma Health-Upstate
Little is known regarding the effect of antenatal COVID-19 on pregnancy outcomes. The purpose of this study is to determine of COVID-19 alters histopathology and gene expression of the placenta, as evidenced by analysis at time of delivery. The analysis will aim to identify whether resulting abnormal placental pathology or altered metabolism is associated with severity of symptoms (specifically pneumonia, or need for admission), gestational age at onset, and/or placenta efficiency. Histological and gene expression analysis of the placental post-delivery will determine if COVID-19 alters overall placental structure, vascularization, and/or the transcriptome.
Groupe Hospitalier Paris Saint Joseph
Between March and May 2020, Ile-de-France hospitals faced an influx of patients infected with the COVID 19 virus. Faced with the scale of the pandemic, the aggressiveness of this pathology, severe respiratory complications and the shortage of resuscitation beds , the teams had to make difficult decisions on the therapeutic strategy, the orientation of patients in the event of respiratory distress and their intensive care status. To do this, each establishment reflected in an emergency context on procedures for collegial deliberation and assistance in ethical reflection, based on the recommendations of the National Consultative Ethics Committee and learned societies such as the French Society. of Anesthesia and Resuscitation or the French Society of Support and Palliative Care. Some hospitals had already institutionalized the ethical approach upstream of the health crisis. For example, the Groupe d'Aide à la Réflexion Éthique Clinique (GAREC) was created in November 2005 within the Paris Saint-Joseph Hospital Group. GAREC is a collegial and multidisciplinary entity, made up of 8 members who intervene at the request of caregivers when a clinical situation turns out to be ethically complex. He gives an advisory opinion, the decision belonging to the referring physician. At the start of the COVID period, GAREC changed its structure, organization and operation in order to respond to the multiple issues posed by the complexity of the health situation. This study seeks to analyze the adaptation mechanisms put in place by this group during the epidemic period as well as the nature of the benefit provided to the caregivers who requested it, to the patients and to their relatives. - Adaptation mechanisms: during the COVID period, GAREC was extended to other paramedical professions (psychologists, nurses), thus increasing from 8 to 15 members. It has set up 2 weekly meetings, an on-call duty and on-call duty. The requests were made easier: they could be done by phone, by email, day or night. Several questions emerge: What were the motivations for enlarging the group? How were the members integrated into this group? What were its operating methods? How and by whom was it seized? For what purpose? Were the intervention teams multidisciplinary? - Nature of the benefit provided by GAREC: it will be approached by semi-structured interviews via a qualitative research method. This work is part of a broader reflective perspective: - What representation of ethics underlies this device? - Does the institutionalization of ethics help to enhance or make invisible what ethics owes to daily healthcare practices? - To what extent does the institutionalization of clinical ethics make health institutions more human and virtuous? - Under what conditions can a device like GAREC go beyond the role of ethical guarantor and transform the institution and nursing practices in the service of a collective reflective approach? This study will be carried out on patient data usually collected as part of their care and on data collected through semi-structured interviews with healthcare professionals. As such, it fits into the perspective of grounded theory.
Covance
Coronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19 study is to evaluate the clinical performance and to provide data for clinical validation for the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support of Adaptive's Emergency Use Authorization (EUA) request for T-Detect™ SARS-CoV-2 and secondary aims. This assay is intended to detect immune response to the virus that causes coronavirus disease (COVID-19), SARS-CoV-2. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot.