COVID-19 Clinical Trials and Expanded Access

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.

The design included 152 patients with confirmed heart failure (HF) evaluated in two different periods of time: a baseline before the outbreak, and other during the outbreak of which 76 patients were randomized in each group. A care and follow-up guide was used as an instrument through a face-to-face survey (baseline group) and telemedicine (group outbreak). The primary outcome was the comparison of functional class modification observed in patients

The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute Respiratory Distress Syndrome (ARDS)

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.

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.

Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.

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.

The objective of MoxiCov is to monitor the oximetry of patients admitted to the Covid nursery to provide a more detailed assistance expecting to reduce the amount of hypoxia in these patients.

Lifespan Cancer Institute serves over 50% of cancer patients in the state. Rhode Island is known for strong medical care and high rates of cancer screening with mammography and colonoscopy. However, cancer screening has plummeted during the COVID-19 pandemic, in part to closing physician offices and stopping non-urgent medical procedures. In addition, anecdotal reports suggest the public remains concerned about returning to physician's offices and risking possible exposure to COVID-19. As in the United States as a whole, COVID-19 has disproportionately impacted ethnic and minority individuals within underserved communities; and in Rhode Island, African Americans, Hispanics and undocumented individuals living in communities such as Central Falls, Pawtucket, Providence, East Providence and North Providence have had the highest rate of COVID-19. These communities are also impacted by healthcare disparities to access and affordability of healthcare, and as such, may be among the least likely to resume cancer screening. The Lifespan Cancer Institute will institute a project to address health disparities in cancer screening during the pandemic through the use of a targeted campaign involving social media. The goals will be to re-establish screening in the era of COVID-19 and ensure timeliness of care for those found to be at risk, or are positive for, cancer.

The aim of the study will be to determine the epidemiological and clinical features of COVID-19 cases, immunological and virological courses, interaction with nutritional status, and response to treatment for COVID-19 patients admitted to treatment centers in Ethiopia. Methods: This multi-site cohort enrolls, patients with confirmed COVID-19 infection admitted to treatment centers will be enrolled irrespective of their symptoms and followed up for 12 months. Baseline epidemiological, clinical, laboratory and imaging data will be collected from treatment records, interviews, physical measurements and biological samples. Endline data involves treatment and prognostic outcomes to be measured using different biomarkers and clinical parameters, The patients will be followed up in the selected treatment centers for COVID-19 infection. For all data collected both descriptive and multivariable analyses will be performed to isolated determinants of the treatment outcome and prognosis to generate relevant information for informed prevention and case management.