COVID-19 Clinical Trials and Expanded Access

To evaluate the effectiveness of Hydroxychloroquine Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).

The outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been declared a public health emergency of international concern. Hospitalized COVID-19-positive patients requiring ICU care is increasing along with the course of epidemic. A large number of these patients developed acute respiratory distress syndrome (ARDS) according to current data. However, the related hemodynamic characteristic has so far been rarely described.

Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated. We propose to compare to the Gold-Standard defined above, the combination of an SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.

RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.

COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue. While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation. Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients. Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date. Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.

The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).

COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

SARS-CoV-2 vaccine, now being administered to skilled nursing facility (SNF) residents and staff, has highly variable acceptance between facilities. The investigators need to develop and disseminate effective strategies to increase vaccination immediately. For SNF residents and staff, the investigators will develop and implement a scalable multi-pronged intervention that educates, builds trust and supports the informed consent process aimed to increase SARS-CoV-2 vaccination. The investigators will conduct a cluster randomized trial to compare the effect of electronic messaging and education (i.e., usual care) versus a multi-pronged 'high touch' intervention to reduce vaccine hesitancy in skilled nursing facility staff and residents among a random sample of facilities across four SNF chains. As part of the 'high touch' intervention, the investigators will identify and train local opinion leaders. The investigators will offer these leaders assistance through real-time support for questions and provide consenting specialists. During the second wave of vaccination, the investigators will provide the intervention facilities with positive reinforcement for staff and will identify local champions to garner support and empowerment of staff. Finally, in the intervention facilities, the investigators will provide additional funds to support COVID-19 testing, in order that facilities have access to enough testing kits for patient or staff who develops symptoms following vaccination. This trial will be randomized within four SNF chains in order to evaluate the effect of a multi-pronged strategy to improve SARS-CoV-2 vaccine acceptance among direct care staff and long-stay nursing home residents. In four chains, eligible facilities will undergo randomization between usual care versus adding the 'high touch' intervention, implemented in two waves. Randomization and roll out of the intervention will occur at the facility level. The investigators hypothesize that: (1) the intervention will increase vaccination of SNF residents by at least 10 percentage points versus facilities usual care alone; (2) staff of SNFs with the intervention will have at least a 10 percentage point greater vaccine uptake of vaccine than staff in SNFs that do not participate in the high touch intervention; and (3) within intervention SNFs, improvements in vaccine uptake will be similar across staff and resident race/ethnicities.

Severe SARS-CoV-2 infections are frequently associated with the acute respiratory distress syndrome (ARDS), which leads to a mortality of 30-40%. An altered type I interferon (IFN) response has been demonstrated in patients with severe COVID-19, together with a high viral load. The aim of the current work is, in a large cohort of patients with severe COVID-19 admitted in the ICU, to determine the prevalence of patients with positive anti-IFN antibodies and to determine their outcome, as compared to patients having negative anti-IFN antibodies.

The main objective is to evaluate the efficacy and safety of three doses of tinzaparin (prophylactic, intermediate and therapeutic) in hospitalized patients with COVID-19 pneumonia.