Name (Synonyms) | Correlation | |
---|---|---|
drug552 | Nitric Oxide Wiki | 0.24 |
drug264 | Discontinuation of ACEi/ARB Wiki | 0.17 |
drug166 | CYNK-001 Wiki | 0.17 |
drug294 | Examine the impact of COVID-19 during pregnancy Wiki | 0.17 |
drug365 | Hydroxychloroquine + azithromycin + / - tocilizumab Wiki | 0.17 |
drug258 | Dexamethasone Wiki | 0.17 |
drug961 | hydroxychloroquine + azithromycin Wiki | 0.17 |
drug389 | Hydroxychloroquine and Azithromycin Wiki | 0.17 |
drug666 | Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19) Wiki | 0.17 |
drug205 | Clopidogrel Wiki | 0.17 |
drug1030 | standardized Lung Ultrasound (LUS) examination Wiki | 0.17 |
drug792 | Sterile Normal Saline for Intravenous Use Wiki | 0.17 |
drug923 | alveolar recruitment Wiki | 0.17 |
drug367 | Hydroxychloroquine + placebo Wiki | 0.17 |
drug887 | VC Wiki | 0.17 |
drug183 | Centricyte 1000 Wiki | 0.17 |
drug119 | Biological collection (patients co infected HIV Sras-CoV-2) Wiki | 0.17 |
drug143 | CAStem Wiki | 0.17 |
drug607 | Pembrolizumab (MK-3475) Wiki | 0.17 |
drug299 | Exposure (not intervention) - SARS-CoV-2 infection Wiki | 0.17 |
drug81 | Azinc Wiki | 0.17 |
drug315 | Fondaparinux Wiki | 0.17 |
drug735 | Scanning Chest X-rays and performing AI algorithms on images Wiki | 0.17 |
drug1038 | turkish physicians Wiki | 0.17 |
drug951 | eculizumab Wiki | 0.17 |
drug874 | UNIKINON (Chloroquine phosphate) 200mg tablets Wiki | 0.17 |
drug623 | Placebo for Hydroxychloroquine Wiki | 0.17 |
drug581 | Oral placebo Wiki | 0.17 |
drug682 | Ravulizumab Wiki | 0.17 |
drug622 | Placebo for Azithromycin Wiki | 0.17 |
drug121 | Biological test Wiki | 0.17 |
drug567 | Normal saline Wiki | 0.17 |
drug409 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.17 |
drug715 | SARS-CoV-2 IgG Antibody Testing Kit Wiki | 0.17 |
drug31 | Acetylsalicylic acid Wiki | 0.17 |
drug463 | Liberase Enzyme (Roche) Wiki | 0.17 |
drug500 | Mefloquine + azithromycin + / - tocilizumab Wiki | 0.17 |
drug377 | Hydroxychloroquine Sulfate + Azithromycin Wiki | 0.17 |
drug426 | Injective placebo Wiki | 0.17 |
drug588 | Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki | 0.17 |
drug798 | Study Group Wiki | 0.17 |
drug83 | Azithromycin (Azithro) Wiki | 0.17 |
drug74 | Auto-questionnaires (patients co infected HIV Sras-CoV-2) Wiki | 0.17 |
drug561 | No special intervention Wiki | 0.17 |
drug229 | Convalescent anti-SARS-CoV-2 plasma Wiki | 0.17 |
drug499 | Mefloquine Wiki | 0.17 |
drug967 | iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System Wiki | 0.17 |
drug114 | Best Supportive Care Wiki | 0.17 |
drug339 | Halo Oral Spray Wiki | 0.17 |
drug217 | Continuation of ACEi/ARB Wiki | 0.17 |
drug793 | Sterile Water for Injection Wiki | 0.17 |
drug851 | Tirofiban Injection Wiki | 0.17 |
drug509 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.17 |
drug340 | Halo Placebo Wiki | 0.17 |
drug107 | Baricitinib Wiki | 0.12 |
drug555 | Nivolumab Wiki | 0.12 |
drug752 | SivoMixx (200 billion) Wiki | 0.12 |
drug364 | Hydroxychloroquine + azithromycin Wiki | 0.12 |
drug648 | Prednisone Wiki | 0.12 |
drug313 | Follow up Wiki | 0.12 |
drug361 | Hydroxychloroquine (HCQ) Wiki | 0.10 |
drug960 | hydroxychloroquine Wiki | 0.10 |
drug484 | Lung ultrasound Wiki | 0.10 |
drug222 | Control group Wiki | 0.10 |
drug872 | UC-MSCs Wiki | 0.09 |
drug208 | Colchicine Wiki | 0.08 |
drug732 | Sarilumab Wiki | 0.07 |
drug46 | Anakinra Wiki | 0.06 |
drug360 | Hydroxychloroquine Wiki | 0.06 |
drug558 | No intervention Wiki | 0.06 |
drug375 | Hydroxychloroquine Sulfate Wiki | 0.05 |
drug854 | Tocilizumab Wiki | 0.04 |
drug82 | Azithromycin Wiki | 0.04 |
Name (Synonyms) | Correlation | |
---|---|---|
D011014 | Pneumonia NIH | 0.45 |
D008171 | Lung Diseases, NIH | 0.26 |
D053717 | Pneumonia, Ventilator-Associated NIH | 0.19 |
D017563 | Lung Diseases, Interstitial NIH | 0.17 |
D001261 | Pulmonary Atelectasis NIH | 0.17 |
D011251 | Pregnancy Complications, Infectious NIH | 0.17 |
D011248 | Pregnancy Complications NIH | 0.17 |
D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.17 |
D007154 | Immune System Diseases NIH | 0.17 |
D011649 | Pulmonary Alveolar Proteinosis NIH | 0.17 |
D016769 | Embolism and Thrombosis NIH | 0.17 |
D004617 | Embolism NIH | 0.17 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.17 |
D055370 | Lung Injury NIH | 0.16 |
D055371 | Acute Lung Injury NIH | 0.14 |
D018352 | Coronavirus Infections NIH | 0.13 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.13 |
D030341 | Nidovirales Infections NIH | 0.12 |
D012327 | RNA Virus Infections NIH | 0.12 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.11 |
D003333 | Coronaviridae Infections NIH | 0.10 |
D011658 | Pulmonary Fibrosis NIH | 0.10 |
D004417 | Dyspnea NIH | 0.10 |
D008173 | Lung Diseases, Obstructive NIH | 0.09 |
D003141 | Communicable Diseases NIH | 0.08 |
D013577 | Syndrome NIH | 0.08 |
D007239 | Infection NIH | 0.07 |
D013927 | Thrombosis NIH | 0.07 |
D012140 | Respiratory Tract Diseases NIH | 0.06 |
D007251 | Influenza, Human NIH | 0.06 |
D014777 | Virus Diseases NIH | 0.06 |
D002318 | Cardiovascular Diseases NIH | 0.05 |
D012141 | Respiratory Tract Infections NIH | 0.04 |
D016638 | Critical Illness NIH | 0.04 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002098 | Respiratory distress HPO | 0.12 |
HP:0002090 | Pneumonia HPO | 0.11 |
There are 34 clinical trials
Due to the outbreak of 2019 Novel Coronavirus Pneumonia in Wuhan, Hubei province, medical staff and residents are facing great psychological pressure, the investigator plan to use electronic questionnaire to carry out investigation research.
Description: GHQ-12(general health questionnaire-12): minimal score 0, maximal score 12, higher scores mean a better or worse outcome.
Measure: GHQ-12(general health questionnaire-12) Time: 2 weeksDescription: IES-R(Impact of Event Scale-Revised):score range:0-88, the higher the worse
Measure: IES-R(Impact of Event Scale-Revised) Time: 2 weeks2019 new coronavirus (2019-nCoV) infected pneumonia, namely severe acute respiratory infection (SARI) has caused global concern and emergency. There is a lack of effective targeted antiviral drugs, and symptomatic supportive treatment is still the current main treatment for SARI. Vitamin C is significant to human body and plays a role in reducing inflammatory response and preventing common cold. In addtion, a few studies have shown that vitamin C deficiency is related to the increased risk and severity of influenza infections. We hypothize that Vitamin C infusion can help improve the prognosis of patients with SARI. Therefore, it is necessary to study the clinical efficacy and safety of vitamin C for the clinical management of SARI through randomized controlled trials during the current epidemic of SARI.
Description: days without ventilation support during 28 days after patients' enrollment
Measure: Ventilation-free days Time: on the day 28 after enrollmentDescription: wether the patient survives
Measure: 28-days mortality Time: on the day 28 after enrollmentDescription: days of the patients staying in the ICU
Measure: ICU length of stay Time: on the day 28 after enrollmentDescription: the rate of CPR
Measure: Demand for first aid measuments Time: on the day 28 after enrollmentDescription: days of using vasopressors
Measure: Vasopressor days Time: on the day 28 after enrollmentDescription: P O2/Fi O2 which reflects patients' respiratory function
Measure: Respiratory indexes Time: on the day 10 and 28 after enrollmentDescription: Ecmo or ventilator
Measure: Ventilator parameters Time: on the day 10 and 28 after enrollmentDescription: Acute Physiology and Chronic Health Evaluation
Measure: APACHE II scores Time: on the day 10 after enrollmentDescription: Sepsis-related Organ Failure Assessment
Measure: SOFA scores Time: on the day 10 after enrollmentSerious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia.
Description: partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)
Measure: Oxygenation index Time: on the day 14 after enrollmentDescription: whether the patient survives
Measure: 28 day mortality Time: on the day 28 after enrollmentDescription: days of the patients in hospital
Measure: Hospital stay Time: up to 6 monthsDescription: whether or not the 2019-nCoV nucleic acid test is positive
Measure: 2019-nCoV nucleic acid test Time: on the day 7,14,28 after enrollmentDescription: whether lung imaging examinations show the improvement of the pneumonia
Measure: Improvement of lung imaging examinations Time: on the day 7,14,28 after enrollmentDescription: counts of white blood cell in a litre of blood
Measure: White blood cell count Time: on the day 7,14,28 after enrollmentDescription: counts of lymphocyte in a litre (L) of blood
Measure: Lymphocyte count Time: on the day 7,14,28 after enrollmentDescription: percentage of lymphocyte in white blood cell
Measure: Lymphocyte percentage Time: on the day 7,14,28 after enrollmentDescription: procalcitonin in microgram(ug)/L
Measure: Procalcitonin Time: on the day 7,14,28 after enrollmentDescription: IL-2 in picogram(pg)/millilitre(mL)
Measure: interleukin(IL)-2 Time: on the day 7,14,28 after enrollmentDescription: IL-4 in pg/mL
Measure: IL-4 Time: on the day 7,14,28 after enrollmentDescription: IL-6 in pg/mL
Measure: IL-6 Time: on the day 7,14,28 after enrollmentDescription: IL-8 in pg/mL
Measure: IL-8 Time: on the day 7,14,28 after enrollmentDescription: IL-10 in pg/mL
Measure: IL-10 Time: on the day 7,14,28 after enrollmentDescription: TNF-α in nanogram(ng)/L
Measure: tumor necrosis factor(TNF)-α Time: on the day 7,14,28 after enrollmentDescription: γ-IFN in a thousand unit (KU)/L
Measure: γ-interferon(IFN) Time: on the day 7,14,28 after enrollmentThe scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (COVID-19) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on COVID-19 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.
Description: The primary outcome will be the proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring intubation and mechanical ventilation. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.
Measure: Reduction in the incidence of intubation and mechanical ventilation Time: 28 daysDescription: Mortality from all causes
Measure: Mortality Time: 28 daysDescription: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab
Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract Time: 7 daysDescription: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent).
Measure: Time to clinical recovery Time: 28 daysThe scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.
Description: The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.
Measure: Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation Time: 28 daysDescription: Proportion of deaths from all causes
Measure: Mortality Time: 28 daysDescription: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours.
Measure: Time to clinical recovery Time: 28 daysDescription: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or oropharyngeal swab.
Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract Time: 7 daysThis project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza
Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive
Measure: COVID-19 positive X-Rays Time: 6 monthsDescription: Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative
Measure: COVID-19 negative X-Rays Time: 6 monthsThe Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.
Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)
Measure: Evaluation of the clinical status Time: 15 days after randomizationDescription: All-cause mortality rates at 29 days after randomization
Measure: All-cause mortality Time: 29 days after randomizationDescription: Evaluation of the clinical status of patients on the 7th and 29th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)
Measure: Evaluation of the clinical status Time: 7 and 29 days after randomizationDescription: Number of days free from mechanical ventilation at 29 days after randomization
Measure: Number of days free from mechanical ventilation Time: 29 days after randomizationDescription: Number of days that the patient was on mechanical ventilation after randomization
Measure: Duration of mechanical ventilation Time: 7, 15 and 29 days after randomizationDescription: Length of hospital stay on survivors
Measure: Duration of hospitalization Time: 7, 15 and 29 days after randomizationDescription: Presence of other secondary infections
Measure: Other secondary infections Time: 7, 15 and 29 days after randomizationDescription: Time from treatment start to death
Measure: Time from treatment start to death Time: 7, 15 and 29 days after randomizationDescription: Occurrence of QT interval prolongation
Measure: QT interval prolongation Time: 7, 15 and 29 days after randomizationDescription: Occurrence of gastrointestinal intolerance
Measure: Gastrointestinal intolerance Time: 7, 15 and 29 days after randomizationDescription: Occurrence of laboratory albnormalities in red blood cell count, creatinine and bilirubin
Measure: Laboratory albnormalities Time: 7, 15 and 29 days after randomizationDescription: Occurrence of adverse events related to the use of the investigational products
Measure: Adverse events Time: 7, 15 and 29 days after randomizationGrowing evidences are showing the usefulness of lung ultrasound in patients with COVID-19. Sars-CoV-2 has now spread in almost every country in the world. In this study, the investigators share their experience and propose a standardized approach in order to optimize the use of lung ultrasound in covid-19 patients. The investigators focus on equipment, procedure, classification and data-sharing.
Description: Scoring procedures Score 0: The pleura line is continuous, regular. Horizontal artifacts (A-line) are present. These artifacts are generally referred as A-lines. Score 1: The pleura line is indented. Below the indent, vertical areas of white are visible. Score 2: The pleura line is broken. Below the breaking point, small to large consolidated areas (darker areas) appear with associated areas of white below the consolidated area (white lung). Score 3: The scanned area shows dense and largely extended white lung with or without larger consolidations At the end of the procedure, the clinician will write for each area the highest score obtained.
Measure: Lung ultrasound grading system for COVID-19 pneumonia Time: At enrollment.Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections [3]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with SARS or MERS . The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and increased NLR in infected patients are correlated with the severity of the disease and adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19 pathogenesis. Importantly, previous studies showed that viroporin E, a component of SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome activation . The mechanisms are unclear. Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome, thereby reducing the release of IL-1b and an array of other interleukins, including IL-6, that are formed in response to danger signals. Recently, colchicine has been successfully used in two cases of life-threatening post-transplant capillary leak syndrome. These patients had required mechanically ventilation for weeks and hemodialysis, before receiving colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs [4].
Description: Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale
Measure: Clinical improvement Time: Day 28Description: Live discharge from the hospital (whatever comes first)
Measure: Hospital discharge Time: Day 28Description: Number of death patients
Measure: Death Time: Day 28Description: 7-category ordinal scale
Measure: Clinical status Time: Day 7, Day 14Description: Number of patients with mechanical ventilhation
Measure: Mechanical ventilhation Time: Day 28Description: Days of hospitalization
Measure: Hospitalization Time: Day 28Description: Days to death from treatment initiation
Measure: Time from treatment initiation to death Time: Day 28Description: negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Measure: Time to Negativization COVID 19 Time: Day 21Description: Time to remission of fever in patients with T>37.5°C at enrollment
Measure: Fever Time: Day 1,4,7,14,21,28It has been reported that nearly half of the patients who are hospitalized for Covid-19 pneumonia have on admission old age or comorbidities. In particular, hypertension was present in 30% of the cases, diabetes in 19%, coronary heart disease in 8% and chronic obstructive lung disease in 3% of the patients. Amazingly, in the two major studies published in the Lancet (Zhou F et al Lancet 2020) and in the New England Journal of Medicine (Guan W et al 2020), the weight of the subjects as well their body mass index (BMI) were omitted. However, obesity, alone or in association with diabetes, can be a major predisposition factor for Covid-19 infection. The primary end-point of our prospective, observational study is to assess the recovery rate in patients with diagnosis of Covid-19 pneumonia. Among the other secondary end-points, we intend to find the predictors of the time to clinical improvement or hospital discharge in patients affected by Covid-19 pneumonia.
Description: mean rate of recovery in patients with diagnosis of Covid-19 pneumonia, who present with complications at the time of hospital admission (such as diabetes, obesity, cardiovascular disease, hypertension or respiratory failure), with the mean recovery rate in patients without any of the above-mentioned complications.
Measure: rate of recovery Time: 3 weeksDescription: comparison of the survival curves (times to improvement) in the two groups (patients with and without complications) and among patients presenting with different types of complications
Measure: time to improvement Time: 3 weeksDescription: the efficacy of different pharmaceutical treatment against Covid-19
Measure: efficacy of treatments Time: 3 weeksDescription: liver, kidney or multiorgan failure, cardiac failure
Measure: organ failure Time: 3 weeksCOVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: 1 monthDescription: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics
Measure: Pulmonary Function Analysis Time: baseline, 3 Month, 6 monthsDescription: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
Measure: Digital Oximetry Time: 3 months, 6 monthsThe Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Most cases are mild or asymptomatic. However, around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which is the leading mortality cause in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. Nevertheless, no large, randomized, controlled trial was performed evaluating the role of corticosteroids in patients with ARDS due SARS-CoV2 virus. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.
Description: Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.
Measure: Ventilator-free days Time: 28 days after randomizationDescription: Evaluation of the clinical status of patients on the 15th day after randomization defined by the 6-point Ordinal Scale, this scale ranges from 1 (Not hospitalized) to 6 (Death) with higher scores meaning worse outcomes.
Measure: Evaluation of the clinical status Time: 15 days after randomizationDescription: All-cause mortality rates at 28 days after randomization.
Measure: All-cause mortality Time: 28 days after randomizationDescription: Number of days of mechanical ventilation from randomization to day 28.
Measure: Mechanical ventilation duration Time: 28 days after randomizationDescription: Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization
Measure: Sequential Organ Failure Assessment (SOFA) Score Time: Score at 48 hours, 72 hours and 7 days after randomizationDescription: Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization.
Measure: Intensive Care Unit free days Time: 28 days after randomizationRationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population. Goals: Primary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children. Secondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes. Methods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days. Timeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements. Impact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.
Description: Clinical characteristics among children presenting to a participating hospital's EDs who meet each site's local SARS-CoV-2 screening criteria, will be described and compared between children with confirmed SARS-CoV-2 (i.e. test-positive) versus suspected (i.e. test-negative) infections.
Measure: Clinical characteristics of children with SARS-CoV-2 Time: 18 monthsDescription: Factors associated with severe outcomes [i.e. positive pressure ventilation (invasive or noninvasive) OR intensive care unit admission with ventilatory or inotropic support OR death; other outcomes may be added as the understanding of the epidemic evolves) will be identified in confirmed paediatric COVID-19 cases.
Measure: Factors associated with severe COVID-19 outcomes Time: 18 monthsDescription: Health care resource utilization for patient management (e.g. frequencies of isolation, laboratory testing, imaging, and supportive care, with associated costs) of both suspected and confirmed SARS-CoV-2 infected children according to changes in national and regional policies.
Measure: Health care resource utilization for COVID-19 patient management Time: 18 monthsDescription: The sensitivity and specificity of various case screening policies for the detection of confirmed symptomatic SARS-CoV-2 infection (i.e. COVID-19) in children (e.g. addition of vomiting/diarrhoea).
Measure: Sensitivity and specificity of COVID-19 case screening policies Time: 18 monthsA phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS.
Description: Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment
Measure: Adverse reaction (AE) and severe adverse reaction (SAE) Time: Within 28 days after treatmentDescription: Evaluation by chest CT
Measure: Changes of lung imaging examinations Time: Within 28 days after treatmentDescription: Marker for SARS-CoV-2
Measure: Time to SARS-CoV-2 RT-PCR negative Time: Within 28 days after treatmentDescription: The duration of a fever above 37.3 degrees Celsius
Measure: Duration of fever (Celsius) Time: Within 28 days after treatmentDescription: Marker for efficacy
Measure: Changes of blood oxygen (%) Time: Within 28 days after treatmentDescription: Marker for efficacy
Measure: Rate of all-cause mortality within 28 days Time: Within 28 days after treatmentDescription: Counts of lymphocyte in a litre (L) of blood
Measure: Lymphocyte count (*10^9/L) Time: Within 28 days after treatmentDescription: Alanine aminotransferase in unit (U)/litre(L)
Measure: Alanine aminotransferase (U/L) Time: Within 28 days after treatmentDescription: Creatinine in micromole (umol)/litre(L)
Measure: Creatinine (umol/L) Time: Within 28 days after treatmentDescription: Creatine kinase in U/L
Measure: Creatine kinase (U/L) Time: Within 28 days after treatmentDescription: C-reactive in microgram (mg)/litre(L)
Measure: C-reactive protein (mg/L) Time: Within 28 days after treatmentDescription: Procalcitonin in nanogram (ng)/litre(L)
Measure: Procalcitonin (ng/L) Time: Within 28 days after treatmentDescription: Lactate in millimole(mmol)/litre(L)
Measure: Lactate (mmol/L) Time: Within 28 days after treatmentDescription: IL-1beta in picogram(pg)/millilitre(mL)
Measure: IL-1beta (pg/mL) Time: Within 28 days after treatmentDescription: IL-2 in pg/mL
Measure: IL-2 (pg/mL) Time: Within 28 days after treatmentDescription: IL-6 in pg/mL
Measure: IL-6 (pg/mL) Time: Within 28 days after treatmentDescription: IL-8 in pg/mL
Measure: IL-8 (pg/mL) Time: Within 28 days after treatmentThis is a prospective, multicenter, randomized, controlled, open-label, phase 2 clinical trial
Description: Assessed by hospital records
Measure: Percentage of patients with normalization of oxygen saturation by pulse oximetry (SpO2) ≥96% Time: through day 14 after study treatment initiationDescription: Assessed by hospital records
Measure: Proportion of patients with temperature < 37,5 °C armpit. Time: through day 14 after study treatment initiationDescription: Assessed by hospital records
Measure: Proportion of patients discharged from the emergency department and classified as low risk Time: In less than 28 daysDescription: The clinical status will be assessed by the SOFA scores
Measure: Change from baseline in organ failure parameters Time: Days 1, 3, 5, 7, 14 (+/- 1 day) and 28 (+/- 2 days) or until discharge whatever it comes first.Description: Determined as percentage of dead patients
Measure: Proportion of mortality rate Time: Day 28Description: Determined as: Time to invasive mechanical ventilation (if not previously initiated); Time to independence from non-invasive mechanical ventilation; Time to independence from oxygen therapy.
Measure: Analysis of the remission of respiratory symptoms Time: Up to 3 months after last dose of treatmentDescription: by using the same imaging technique (chest X-ray or thoracic CT scan)
Measure: Evaluation of the radiological response Time: at days 1 and 28 (+/- 2 days)Description: determined using oropharyngeal or anal swabs
Measure: Time to first negative in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RT-PCR test Time: within 28 days from study inclusionDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of absolute lymphocyte count (ALC),white blood cell count and white blood cell differential count Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of hemoglobin Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of platelets Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of activated partial thromboplastin time (aPTT) Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of creatinine Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of glucose Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of total bilirubin Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Baseline defined as the value collected at day 1, 2 hours before treatment administration
Measure: Change from baseline of albumin Time: days 3, 5, 7, 10, 14 and 28 after administration of study drugDescription: Evaluated using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0), SOFA scores.
Measure: Incidence of adverse events (AEs), incidence of prespecified AEs (safety and tolerability) Time: Up to 28 days after last dose of treatmentThe objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit. A Multicenter Observational Study.
Description: Mortality 30 days following hospital admission
Measure: Hospital mortality Time: 30 daysDescription: The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge
Measure: Length of stay in the intensive care unit Time: Through study completion, an average of 30 daysSince December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.
Description: Mortality at day 28
Measure: Mortality at day 28 Time: day 28Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No
Measure: severe complications Time: up to day 28Description: Delay in imaging in hours
Measure: Imaging Time: day 1Description: delay in microbiological diagnosis in hours
Measure: Delay in Microbiological diagnosis Time: day 1Description: Antiviral therapy Yes / no
Measure: Antiviral therapy Time: up to day 28Description: Antibiotic therapy Yes / No
Measure: Antibiotic therapy Time: day 28Description: Covid-19 treatments Yes / No
Measure: Covid-19 treatments Time: up to day 28Description: number
Measure: Patients receiving renal replacement therapy Time: up to day 28Description: number
Measure: Patients receiving mechanical ventilation Time: up to day 28Description: Patient alive at day 28 : yes / No
Measure: Vital status Time: day 28Clinical thoracic ultrasound plays an important role in the exploration, diagnosis and follow-up of thoracic pathologies. The COVID (Coronavirus Disease) epidemic is leading to a large influx of patients in the emergency department with respiratory disorders. The rapid diagnosis of respiratory disorders in infected patients is important for further management. Chest ultrasound has already demonstrated its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray. However, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.
Description: description of ultrasound abnormalities for Covid-19 patients
Measure: Characteristics of pulmonary ultrasound for Covid-19 patients Time: Day oneDescription: description of ultrasound abnormalities for Covid-19 patients
Measure: Characteristics of pulmonary ultrasound for Covid-19 patients Time: Day 3Description: description of ultrasound abnormalities for Covid-19 patients
Measure: Characteristics of pulmonary ultrasound for Covid-19 patients Time: Day 14Description: description of CT-scan abnormalities for Covid-19 patients
Measure: Charateristics of pulmonary CT-scan for Covid-19 patients Time: Day 1Description: description of CT-scan abnormalities for Covid-19 patients
Measure: Charateristics of pulmonary CT-scan for Covid-19 patients Time: Day 3Description: description of CT-scan abnormalities for Covid-19 patients
Measure: Charateristics of pulmonary CT-scan for Covid-19 patients Time: Day 14Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease. During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection. The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome. The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.
Description: SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.
Measure: Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. Time: 7 daysDescription: level1: not hospitalized no limited activities, level 7: death
Measure: disease severity assessed on a 7-level ordinal scale Time: 7 daysDescription: Reduction of radiological signs on chest imaging
Measure: radiological signs on chest imaging Time: 7 daysDescription: duration on days
Measure: Duration of oxygen therapy Time: 21 daysThis is an open label clinical study to evaluate the activity of chloroquine phosphate in patients with SARS-CoV-2 virus infection. The study aims to document possible prevention of pneumonia in patients staying at home and in improving the symptoms of SARS-CoV-2 pneumonia in patients who will be hospitalised.
Description: Achieving 50% reduction in symptom score for patients with lower respiratory tract infection on day 8 visit from study initiation.
Measure: 50% reduction in symptom score for patients with lower respiratory tract infection Time: Day 8 visit from study initiationDescription: Lack of progression to lower respiratory tract infection in patients enrolled in the study due to upper respiratory tract infection on day 8 visit from study initiation.
Measure: Lack of progression for patients with upper respiratory tract infection Time: Day 8 visit from study initiationDescription: Lower respiratory tract infection rating takes place. The symptoms checked are: Cough, Chest pain, Dyspnea, expectoration. For each symptom score is given from 0 to 3 depending on the intensity and they are summed.
Measure: Comparison of the primary endpoint with respective patients not receiving the treatment Time: Day 14 visit from study initiationDescription: It is defined as the presence of both of the following: Respiratory quotient (pO2 / FiO2) less than 150 Need for treatment with CPAP or mechanical ventilation
Measure: Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment. Time: Day 14 visit from study initiationDescription: Frequency of AEs and SAEs
Measure: Frequency of AEs and SAEs Time: Day 14 visit from study initiationCCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel treatment option of moderate-severe COVID-19. Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma, sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
Description: Composite outcome
Measure: All-cause mortality or need of invasive mechanical ventilation Time: 28 daysDescription: Number of participants with adverse events with possible relation to study drug
Measure: Frequency of adverse events Time: 90 daysDescription: Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Measure: Frequency of severe adverse events Time: 90 daysDescription: Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities
Measure: Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status Time: 90 daysDescription: Number of days without mechanical ventilation
Measure: Ventilator-free days Time: 28 daysDescription: Number of days without organ-failure
Measure: Organ failure-free days Time: 28 daysDescription: Number of days in ICU
Measure: Duration of ICU stay Time: 90 daysDescription: Number of deaths by any cause
Measure: Mortality rate Time: 7, 14, 21, 28 and 90 daysDescription: Days from the date of hospital admission for COVID-19 to the date of discharge
Measure: Length of hospital stay Time: 90 daysDescription: Days requiring supplement oxygen
Measure: Duration of supplemental oxygen Time: 90 daysDouble blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.
Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)
Measure: Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment). Time: up to Day 11Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29
Measure: Clinical status assessed by ordinal scale Time: up to Day 29Description: Necessity for transfer to Intensive care unit
Measure: transfer to ICU Time: up to Day 29Description: days from admission to hospital discharge
Measure: Length of hospital day Time: up to Day 29Description: incidence of all-cause mortality
Measure: Hospital Mortality Time: Day 29Description: Need to mechanical ventilation
Measure: Need to Mechanical Ventilation Time: up to Day 29Description: adverse reactions
Measure: Occurence of grade 3-4 adverse event Time: up to Day 29Description: ECG
Measure: QTc Lengthening Time: up to Day 11Description: Thoracic CT scan : number and size of ground-glass opacifications on day 1 and day 11 Two independent pulmonary imagery experts will assess abnormalities according to a standardized framework
Measure: Evolution of pulmonary CT scan images Time: up to Day 11Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.
Description: The number of patients with development of respiratory failure requiring transfer to the ICU.
Measure: 1st primary endpoint for group 1 Time: up to 3 monthsDescription: The period of clinical recovery.
Measure: 2nd primary endpoint for group 1 Time: through study completion, an average of 3 monthsDescription: The period of clinical recovery.
Measure: 1st primary endpoint for group 2 Time: through study completion, an average of 3 monthsDescription: Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)
Measure: 2nd primary endpoint for group 2 Time: through study completion, an average of 3 monthsDescription: A change in viral load by conducting PCR assay through different timeframes
Measure: 1st secondary endpoint for group 1 Time: on days 5, 10 and 90Description: Frequency of clinical recovery on day 10 from the start of therapy
Measure: 2nd secondary endpoint for group 1 Time: on day 10Description: The retention time of the reaction temperature from the start of treatment.
Measure: 3d secondary endpoint for group 1 Time: up to 3 monthsDescription: Concentration of C-reactive protein in blood plasma.
Measure: 4th secondary endpoint for group 1 Time: up to 3 monthsDescription: Respiratory index.
Measure: 5th secondary endpoint for group 1 Time: up to 3 monthsDescription: Frequency of adverse events and serious adverse events
Measure: 6th secondary endpoint for group 1 Time: through study completion, an average of 3 monthsDescription: A change in viral load by conducting PCR assay through different timeframes
Measure: 1st secondary endpoint for group 2 Time: on days 5, 10 and 90Description: Respiratory index.
Measure: 2nd secondary endpoint for group 2 Time: up to 3 monthsDescription: The retention time of the reaction temperature from the start of treatment.
Measure: 3d secondary endpoint for group 2 Time: up to 3 monthsDescription: Concentration of C-reactive protein in blood plasma.
Measure: 4th secondary endpoint for group 2 Time: up to 3 monthsDescription: Number of patients required transition to alternative therapy schedule
Measure: 5th secondary endpoint for group 2 Time: through study completion, an average of 3 monthsDescription: Frequency of adverse events and serious adverse events
Measure: 6th secondary endpoint for group 2 Time: through study completion, an average of 3 monthsCurrently there is a great need for an accurately and rapid assessment of patients suspected for Covid-19. Like CT, Lung Ultrasound (LUS) examination can potentially help with the initial triage of patients but also help track the evolution of the disease. LUS can be used in every setting, including settings with limited infrastructure, allowing the reduction of disparities in trials participation. LUS is also a practical approach that can be used by obstetricians/gynecologists, who are the primary care givers in the labour and delivery room. The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter prospective explorative observational study to assess the predictive value of LUS in Covid-19 suspected and diagnosed pregnant patients.
Description: The primary endpoint is diagnostic performance in terms of the area under the receiver operating characteristic curve (AUC, also known as the c-statistic) and sensitivity and specificity with regard to the prediction of poor outcome. Outcome at one week from admission: good outcome includes discharge or inpatient breathing in free air; poor outcome includes patient with oxygen support, patients with CPAP/ high oxygen flow cannula, or patient with endotracheal intubation during the week.
Measure: Diagnostic performance of LUS to predict poor outcome Time: outcome one week after enrollment into the studyThis protocol provides access to eculizumab treatment for participants with severe COVID-19.
This is an open-label, controlled, single-centre pilot study of nivolumab in adult patients with COVID-19. This clinical study aims to evaluate efficacy of anti-PD1 antibody in relation to viral clearance and its safety.
Description: Viral load changes in NPS based on SARS-CoV-2 RT-PCR
Measure: Viral clearance kinetics Time: From diagnosis to recovery, assessed up to 6 monthsDescription: Incidence and severity of treatment-related adverse events
Measure: Treatment-related adverse events of nivolumab (Intervention arm only) Time: Up to 1 year after nivolumab dosingDescription: Changes in lymphocyte counts
Measure: Lymphocyte kinetics Time: On days 1, 4, 6, 8, 10 and 28 from study enrollmentDescription: Changes in cytokine levels (e.g. IL-1B, IL-2, IL-6, TNFa)
Measure: Cytokine kinetics Time: On days 1, 4, 6, 8 and 10 from study enrollmentThe search for novel therapies to address the ongoing coronavirus (COVID-19) pandemic is ongoing. No proven therapies have been identified to prevent progression of the virus. Preliminary data suggest that inhaled nitric oxide (iNO) could have benefit in preventing viral progression and reducing reliance on supplemental oxygen and ventilator support. Expanded access allows for iNO to be delivered via the portable INOpulse delivery system for the treatment of COVID-19.
Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.
Description: relative abundances and diversity indices
Measure: Composition of the fecal bacterial and fungal microbiota Time: At 28 daysDescription: Alterations in fecal microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls
Measure: Analysis of the faecal microbiota from rectal swab Time: at baseline and every 7 days during 28 daysDescription: Alterations in respiratory microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls
Measure: Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid Time: at baseline and every 7 days during 28 daysDescription: Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline
Measure: Serum inflammatory markers changes Time: at 28 days,Description: changes in Cytokine/ chemokine from baseline
Measure: Inflammatory markers changes Time: at 28 days,Description: death
Measure: Mortality Time: at 28 days,Description: Number of days alive without mechanical ventilation
Measure: mechanical ventilation free days Time: at 28 days,COVID-19 originated from Severe Acut Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection leads to critical condition due to hypoxemic respiratory failure with the background of viral pneumonia. Both alevolar recruitment and the subsequent optimal positive end-expiratory pressure (PEEP) adjustment has a pivotal role in the elimination of atelectasis developed by inflammation in the lung parenchyma The gold standard of the follow up of recruitment manoeuvre is the chest computed tomography (CT) examination. However, reduction of intrahospital transport and the exposure with healthcare workers are recommended because of the extremely virulent pathogen spreading easily by droplet infection. In this case bedside investigations have an utmost importance in the management of hygiene regulations. Electric impedance tomography (EIT) is a non-invasive, radiation free functional imaging technique easily applicable at the bedside.
Description: Estimation of change in compliance (ml/cmH2O) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Measure: Changes in lung compliance Time: 20 minutesDescription: Estimation of change in global impedance (%) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Measure: Change in global impedance Time: 20 minutesDescription: Estimation of change in global impedance (%) on a daily manner.
Measure: Change in recruitability Time: 7 daysDescription: Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment
Measure: Gas exchange Time: 20 minutes and 7 daysDescription: Change in plateau pressure (cmH2O) following recruitment
Measure: Plateau pressure Time: 20 minutes and 7 daysDescription: Change in end expiratory lung impedance (%)
Measure: End expiratory lung impedance (EELI) Time: 20 minutes and 7 daysDescription: Change in antero-to-posterior ventilation ratio (%) following intervention
Measure: Antero-to-posterior ventilation ratio Time: 20 minutes and 7 daysDescription: Change in center of ventilation (%) following intervention
Measure: Center of ventilation Time: 20 minutes and 7 daysDescription: Change in global inhomogeneity index (%) following intervention
Measure: Global inhomogeneity index Time: 20 minutes and 7 daysThis study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in hospitalized patients with moderate COVID-19 disease.
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR
Measure: Time to Clearance of SARS-CoV-2 Time: Up to 12 monthsDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 12 monthsDescription: Time from the date of randomization to the first date of clinical improvement of cough.
Measure: Time to Clinical Improvement of cough Time: Up to 28 daysDescription: Time from the date of randomization to the first date of clinical improvement of fever
Measure: Time to Clinical Improvement of fever Time: Up to 28 daysDescription: Time from the date of randomization to the first date of clinical improvement of radiological evaluation of disease related chest x-ray
Measure: Time to Clinical Improvement in radiological evaluation of disease related chest x-ray Time: Up to 28 daysDescription: Proportion of subjects who achieved clinical improvement of fever
Measure: Rate of Clinical Improvement of fever Time: Up to 28 daysDescription: Proportion of subjects who achieved clinical improvement of cough
Measure: Rate of Clinical Improvement of cough Time: Up to 28 daysDescription: Proportion of subjects who achieved clinical improvement of radiological evaluation of disease related chest x-ray
Measure: Rate of Clinical Improvement of radiological evaluation of disease related chest x-ray Time: Up to 28 daysDescription: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 daysDescription: Proportion of subjects who achieve pulmonary clearance
Measure: Rate of Pulmonary Clearance Time: Up to 28 daysDescription: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 daysDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 12 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 12 monthsItaly was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.
Description: Comparison between the two groups
Measure: Delta in the number of patients requiring orotracheal intubation despite treatment Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of crude mortality Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of length of stay for patients in hospital Time: 90 daysDescription: Comparison between the two groups
Measure: delta in the value of interleukin (IL)-1 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of IL-6 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of IL-10 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR) Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of CD8+ CD38/ HLA-DR Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of fecal calprotectin Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of lipopolysaccharide (LPS) Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of zonulin Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of alpha1-antitrypsin Time: 21 daysThis is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).
Description: Change in ratio between partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, and inspired oxygen fraction at baseline and after study treatment
Measure: P/F ratio Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Change in partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: PaO2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Change in alveolar-arterial gradient of oxygen at baseline and after study treatment. Arterial alveolar gradient will be calculated using the following parameters derived from arterial blood gas analysis: partial pressure of oxygen in arterial blood and partial pressure of carbon dioxide in arterial blood.
Measure: A-a O2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Number of days on continuous positive end expiratory pressure (CPAP)
Measure: CPAP duration Time: From the first day of study drugs administration (T0) until day 7 post study drugs administrationDescription: Difference in intensity of the respiratory support (non invasive mechanical ventilation, CPAP, high flow nasal cannula (HFNC), Venturi Mask, nasal cannula, from higher to lower intensity, respectively) employed at baseline and at 72 and 168 hours after study treatment initiation
Measure: In-hospital change in intensity of the respiratory support Time: At baseline and 72 and 168 hours after treatment initiationDescription: Difference in partial pressure of carbon dioxide in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: PaCO2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in concentration of bicarbonate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: HCO3- difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in concentration of lactate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: Lactate difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in hemoglobin concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.
Measure: Hb difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in platelet concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.
Measure: Plt difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Any major or minor adverse effect occuring during and after the administration of the study drug (e.g. bleeding)
Measure: Adverse effects Time: From the first day of study drugs administration until day 30 post study drugs administrationThis study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.
Is Lung Ultrasound really useful in diagnosing COVID19? What can be the usefulness of the Lung Ultrasound in the COVID19 epidemic? In the current state of the art, Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of Lung Ultrasound in the diagnosis of COVID-19 are not yet known. Alveolar-interstitial lung diseases such as viral pneumonia and ARDS seems to have a specific ultrasound pattern that distinguishes them from bacterial pneumonia, preferentially represented by B lines, morphological irregularity of the pleural line, and small subpleural consolidations, but they could share these patterns with other pathologies, reducing specificity. In Italy, the Lung Ultrasound represents a consolidated method for the evaluation and management of all patients who come to the ER, and what we are sure of is its high sensitivity in identifying pathological patterns. Our preliminary data suggest that Lung Ultrasound is highly reliable not to include but to exclude the diagnosis of COVID-19 in patients with respiratory symptoms.
Description: Lung Ultrasound accuracy in rule-out of patients with respiratory symptoms (fever and / or cough and / or dyspnoea) during the SARS-CoV-2 epidemic compared to nasopharyngeal swab and a composite reference standards
Measure: Negative Predictive Value of Lung Ultrasound in the diagnosis of COVID-19 Time: 30 daysDescription: Lung Ultrasound accuracy in rule-in of patients with respiratory symptoms (fever and / or cough and / or dyspnoea) during the SARS-CoV-2 epidemic compared to nasopharyngeal swab and a composite reference standards
Measure: Positive Predictive Value of Lung Ultrasound in the diagnosis of COVID-19 Time: 30 days