Name (Synonyms) | Correlation | |
---|---|---|
drug872 | UC-MSCs Wiki | 0.23 |
drug29 | Abidol hydrochloride Wiki | 0.22 |
drug232 | Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules Wiki | 0.15 |
drug294 | Examine the impact of COVID-19 during pregnancy Wiki | 0.15 |
drug137 | Bromhexine Hydrochloride Tablets Wiki | 0.15 |
drug586 | Oxygen Wiki | 0.15 |
drug309 | Five-days oseltamivir Wiki | 0.15 |
drug544 | New screening strategy Wiki | 0.15 |
drug320 | Ganovo+ritonavir+/-Interferon nebulization Wiki | 0.15 |
drug311 | Fixed-duration higher dose Hydrocortisone Wiki | 0.15 |
drug887 | VC Wiki | 0.15 |
drug1022 | severe covid-19 pneumonia with ET Wiki | 0.15 |
drug491 | Macrolide administered for 3-5 days Wiki | 0.15 |
drug831 | Ten-days oseltamivir Wiki | 0.15 |
drug530 | NK Cells Wiki | 0.15 |
drug603 | Peginterferon Lambda-1A Wiki | 0.15 |
drug178 | Ceftaroline Wiki | 0.15 |
drug284 | Enoxaparin Wiki | 0.15 |
drug1002 | pirfenidone Wiki | 0.15 |
drug231 | Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) Wiki | 0.15 |
drug366 | Hydroxychloroquine + lopinavir/ritonavir Wiki | 0.15 |
drug503 | Meplazumab for Injection Wiki | 0.15 |
drug472 | Lopinavir / ritonavir tablets combined with Xiyanping injection Wiki | 0.15 |
drug780 | Standard screening strategy Wiki | 0.15 |
drug701 | Ritonavir+Oseltamivir Wiki | 0.15 |
drug28 | Abidol Hydrochloride combined with Interferon atomization Wiki | 0.15 |
drug572 | Observational (registry) Wiki | 0.15 |
drug699 | Rifampin Wiki | 0.15 |
drug1000 | oxyhydrogen Wiki | 0.15 |
drug518 | Moxifloxacin or Levofloxacin Wiki | 0.15 |
drug252 | Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days Wiki | 0.15 |
drug751 | Sirolimus 1 MG/ML Wiki | 0.15 |
drug163 | CT score Wiki | 0.15 |
drug492 | Macrolide administered for up to 14 days Wiki | 0.15 |
drug683 | Recombinant Human Interferon α2b Spray Wiki | 0.15 |
drug911 | Xiyanping injection Wiki | 0.15 |
drug310 | Fixed-duration Hydrocortisone Wiki | 0.15 |
drug433 | Interferon-β1a Wiki | 0.15 |
drug811 | T89 Wiki | 0.15 |
drug747 | Shock-dependent hydrocortisone Wiki | 0.15 |
drug619 | Placebo 250 cc 24 hours continuous infusion for 15 days Wiki | 0.15 |
drug439 | Intravenous Immunoglobulin Wiki | 0.15 |
drug248 | Darunavir and Cobicistat Wiki | 0.15 |
drug179 | Ceftriaxone Wiki | 0.15 |
drug487 | MSCs-derived exosomes Wiki | 0.15 |
drug45 | Amoxicillin-clavulanate Wiki | 0.15 |
drug1044 | γ-Globulin Wiki | 0.15 |
drug59 | Arbidol Hydrochloride Granules Wiki | 0.15 |
drug1033 | thalidomide Wiki | 0.15 |
drug791 | Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki | 0.15 |
drug559 | No intervention (survey study for medical doctors). Wiki | 0.15 |
drug615 | Piperacillin-tazobactam Wiki | 0.15 |
drug473 | Lopinavir / ritonavir, alpha-interferon nebulization Wiki | 0.15 |
drug414 | Immunoglobulin of cured patients Wiki | 0.15 |
drug602 | Patients with the treatment agains COVID19 Wiki | 0.15 |
drug793 | Sterile Water for Injection Wiki | 0.15 |
drug25 | ASC09F+Oseltamivir Wiki | 0.15 |
drug553 | Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki | 0.15 |
drug1031 | systemic treatment Wiki | 0.15 |
drug479 | Lopinavir/ritonavir treatment Wiki | 0.15 |
drug964 | hydroxychloroquine sulfate 200 MG Wiki | 0.15 |
drug482 | Low dose CT Wiki | 0.15 |
drug582 | Oseltamivir Wiki | 0.14 |
drug732 | Sarilumab Wiki | 0.13 |
drug117 | Bevacizumab Injection Wiki | 0.11 |
drug552 | Nitric Oxide Wiki | 0.11 |
drug507 | Methylprednisolone Wiki | 0.11 |
drug558 | No intervention Wiki | 0.11 |
drug58 | Arbidol Wiki | 0.11 |
drug579 | Online questionnaire Wiki | 0.11 |
drug486 | MSCs Wiki | 0.11 |
drug929 | basic treatment Wiki | 0.11 |
drug478 | Lopinavir/ritonavir Wiki | 0.10 |
drug616 | Placebo Wiki | 0.10 |
drug359 | Hydrocortisone Wiki | 0.09 |
drug769 | Standard care Wiki | 0.08 |
drug707 | Ruxolitinib Wiki | 0.07 |
drug46 | Anakinra Wiki | 0.06 |
drug1003 | placebo Wiki | 0.06 |
drug854 | Tocilizumab Wiki | 0.04 |
drug360 | Hydroxychloroquine Wiki | 0.04 |
drug627 | Placebo oral tablet Wiki | 0.03 |
drug82 | Azithromycin Wiki | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
D011014 | Pneumonia NIH | 0.52 |
D011020 | Pneumonia, Pneumocystis NIH | 0.22 |
D053717 | Pneumonia, Ventilator-Associated NIH | 0.17 |
D000077299 | Healthcare-Associated Pneumonia NIH | 0.15 |
D018352 | Coronavirus Infections NIH | 0.13 |
D012598 | Scoliosi NIH | 0.11 |
D009103 | Multiple Sclerosis NIH | 0.11 |
D011024 | Pneumonia, Viral NIH | 0.11 |
D004417 | Dyspnea NIH | 0.09 |
D012141 | Respiratory Tract Infections NIH | 0.08 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
D007249 | Inflammation NIH | 0.07 |
D003141 | Communicable Diseases NIH | 0.05 |
D007239 | Infection NIH | 0.05 |
D013577 | Syndrome NIH | 0.02 |
D014777 | Virus Diseases NIH | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002098 | Respiratory distress HPO | 0.11 |
HP:0011947 | Respiratory tract infection HPO | 0.06 |
There are 42 clinical trials
Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories. The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.
The purpose of the study is to determine if the clinical course of pneumonia is more severe when both, bacterial and viral pathogens are find as possible causative agent and how does it affect treatment.
Diagnosis of pneumonia in the elderly is difficult because of the poor sensitivity and specificity of clinical signs as well as images from chest radiography (RT). New diagnostic tools such as thoracic low-dose computed tomography (CT), which exposes the patient to a weak dose of irradiation, could improve diagnosis. Moreover, low-dose CT could provide additional accuracy in the etiological clarification of pneumonia in elderly people. As a first step, the investigators aim to perform a 1 year (12 months of inclusion + 3 months of follow-up) prospective study including the Divisions of Internal Medicine, Rehabilitation, Geriatrics and Radiology of the University Hospitals of Geneva. In this study, patients >65 years old with a clinical suspicion of low respiratory tract infection (LRTI) will be included. They will be prescribed antimicrobial therapy. Both chest radiography and low-dose thoracic CT will be performed within the first 72 hours after admission, as will blood tests and a nasopharyngeal swab. The clinician's diagnosis, both before and after the results of the CT, will be compared at the end of the study to the adjudication committee's diagnostic opinion which will have access to all available clinical, laboratory and chest X-ray data and which will be considered the gold standard. At the end of the study, all the CT images will be blind-reviewed by two experts in radiology. The impact of CT scanning in the diagnosis of pneumonia will be assessed, both for its sensitivity and specificity in this population. During the first 12 months of the study, all patients will undergo a systematic nasopharyngeal swab at admission and at discharge, from which eluates will be conserved. During the next 12 months, virological and bacteriological polymerase chain reactions (PCR) will be performed, using new diagnostic tools, in order to determine the etiological diagnosis in this population and to evaluate the impact of the new tools in the management of pneumonia for this population. Analysis of these data will allow clinical, radiological and microbiological correlation.
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Two recent meta-analyses suggest a positive effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are based on only four trials gathering less than 300 patients, of which only one was positive. Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more specifically hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy. A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to antibiotics and supportive care, including the correction of hypoxemia. Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the time of inclusion.
Description: For the sub-group of patients included with COVID19, failure is defined as death or need of respiratory support (mechanical ventilation or high-flow oxygen therapy);
Measure: Day 21 failure Time: at day 21Description: Sub-group of patients included with COVID19
Measure: P/F ratio measured daily from Day1 to Day7, at Day 14 and at Day 21 and/or at the end of ICU-stay Time: from day 1 to day 7, at day 14 and day 21 and/or at the end of ICU-stayDescription: Sub-group of patients included with COVID19
Measure: Proportion of patients needing endotracheal intubation Time: at day 21Description: Sub-group of patients included with COVID19
Measure: Proportion of patients experiencing secondary infection during their ICU-stay Time: From baseline to day 21REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome ofon patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic resulting in critical illness. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.
Description: Primary end-point for patients with suspected or proven COVID-19 pandemic infection
Measure: Days alive and outside of ICU Time: Day 21Description: EQ5D-5L and WHODAS 2.0 (not completed in all regions)
Measure: Health-related Quality of life assessment Time: 6 monthsDescription: Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital
Measure: Destination at time of hospital discharge Time: Free text Day 90Description: Antibiotic Domain specific outcome
Measure: Occurrence of multi-resistant organism colonisation/infection Time: Day 90, censored at hospital dischargeDescription: Antibiotic Domain specific outcome
Measure: Occurrence clostridium difficile Time: Day 90, censored at hospital dischargeDescription: Macrolide Duration domain specific outcome, and COVID-19 Antiviral Domain specific outcome.
Measure: Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death Time: Day 90, censored at hospital dischargeDescription: Antiviral Domain specific outcome. Only required at selected sites.
Measure: Change from baseline influenza virus levels in upper and lower respiratory tract specimens Time: Day 3, up to Day 7Description: COVID-19 Antiviral Domain and COVID-19 Immune Modulation Domain specific endpoint
Measure: Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinical testing) Time: Day 90, censored at hospital dischargeThe overall aim of the TREND study is to improve the differential diagnosis of bacterial and viral etiology in children below 5 years of age with clinical community acquired pneumonia. Specific objectives: - To assess the diagnostic accuracy of MxA for viral CAP (sub-study I) - To study etiologies in children with CAP (sub-study II) - To evaluate sensitivity and specificity for MariPOC® Respi test versus PCR for detection of respiratory viruses (sub-study III) - To assess sensitivity and specificity for a novel RPA-based point-of-care test versus PCR for detection of respiratory viruses (sub-study IV) - To assess long-term complications in children with CAP (sub-study V The study takes place at Sachs' Children and Youth hospital in Stockholm.
Description: Clinically relevant difference in MxA-levels between cases with viral and bacterial clinical CAP
Measure: MxA - cases with viral and bacterial clinical CAP Time: 2021Description: Clinically relevant difference in MxA-levels between cases with viral clinical CAP and controls
Measure: Mxa viral clinical CAP and controls Time: 2021Description: Proportion of respiratory pathogens in cases and controls, using real time PCR
Measure: PCR - respiratory pathogens in cases and controls Time: 2020Description: Sensitivity and specificity for different respiratory viruses with MariPOC® Respi as compared to real-time PCR
Measure: Sensitivity and specificity - MariPOC Time: 2021Description: Sensitivity and specificity for different respiratory viruses with a novel PCR-based point-of-care test as compared to PCR
Measure: Sensitivity and specificity a novel PCR-based point-of-care test Time: 2021Description: Difference in asthma prevalence between cases and controls and difference in number of hospital-requiring respiratory infections between cases and controls after 3, 7 and 10 years
Measure: Difference asthma prevalence and number of hospital-requiring respiratory infections - cases and controls, Time: 2027Description: Clinically relevant difference in MxA-levels comparing cases with viral clinical CAP with cases with atypical and mixed viral-bacterial clinical CAP as well as with controls with and without presence of respiratory viruses by PCR
Measure: Specific assessment of MxA as a clinical biomarker Time: 2021Description: Clinically relevant differences in MxA-levels in cases with regard to specific respiratory agents
Measure: Specific assessment of MxA as a clinical biomarker Time: 2021Description: Sensitivity and specificity for MxA in identifying viral clinical CAP
Measure: Specific assessment of MxA as a clinical biomarker Time: 2021Description: Sensitivity and specificity for identifying viral and bacterial infection respectively for CRP, PCT and combination test of CRP, PCT and MxA
Measure: Specific assessment of MxA as a clinical biomarker Time: 2021Description: Difference in CRP and PCT between children with viral, bacterial, atypical bacterial and mixed viral-bacterial infection
Measure: Assessment of PCT and CRP as clinical biomarkers Time: 2021Description: Differences in symptom, antibiotic treatment, acute complications, radiologic exams admission rate and length of stay between cases with viral, bacterial, atypical bacterial and mixed viral-bacterial infection
Measure: Descriptive statistics of study cohort with regard to etiologic agent Time: 2020Description: Differences in symptom, antibiotic treatment, acute complications, radiologic exams admission rate and length of stay between cases who tested positive for respiratory virus by MariPOC® Respi as compared to those with a negative test
Measure: Evaluation of MariPOC® Respi in a clinical setting Time: 2022Description: Number of hospital-requiring respiratory infections in cases and controls
Measure: Assessment of long-term outcomes of children with CAP Time: 2027Description: Difference in asthma prevalence between cases with viral and bacterial clinical CAP as compared to an estimate of the prevalence in the general population
Measure: Assessment of long-term outcomes of children with CAP Time: 2027Description: Difference in proportion of hospital-requiring respiratory infections between cases with viral, bacterial, atypical and mixed viral-bacterial infection
Measure: Assessment of long-term outcomes of children with CAP Time: 2027Description: Difference in MxA-levels between PCR+/MariPOC® Respi+ and PCR+/MariPOC® Respi- study subjects.
Measure: Evaluation of MariPOC® Respi Time: 2022Description: Estimation of etiology of cases using two levels of certainty (definitive as well as probable definition).
Measure: Etiology of cases in TREND study Time: 2020Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.
Description: Measure the number of unanticipated adverse events over the duration of the study protocol
Measure: Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects Time: 26 DaysDescription: Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy
Measure: Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects Time: Day 5,12,19 and 26Description: Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy
Measure: Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum Time: Day 19 and 26Description: Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)
Measure: Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score Time: Day 19 and 26Description: Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.
Measure: Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions Time: Day 26Description: Measured by death from all causes
Measure: Efficacy in reduction of mortality Time: Day 26Description: Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract
Measure: Antiviral effect Time: Day 26Description: Time to clinical recovery as measured by resolution of clinical signs
Measure: Efficacy on clinical improvement Time: Day 26Description: Measured by change in the Modified Jackson Cold Score
Measure: Efficacy on the respiratory symptoms Time: Day 26The aim of this study is to test whether Traditional Chinese Medicines (TCMs) are effective and safe for treating 2019-nCoV infection. After the enrolment of approximately 30 subjects, the recruitment will be paused, and planned interim analysis will be performed to preliminarily investigate the efficacy and safety of TCMs in patients infected with 2019-nCoV.
Description: Symptoms associated with 2019-nCoV infection involve fever and cough.
Measure: Time to complete remission of 2019-nCoV infection-associated symptoms Time: 28 daysDescription: In eligible subjects, the oxygen saturation level is less than 94%, and the respiratory rate is more than 24 breaths per min.
Measure: The incidence of dyspnea with low oxygen saturation level and high respiratory rate Time: 28 daysDescription: Number of subjects who develop complications, including acute respiratory distress syndrome (ARDS), RNAaemia, acute cardiac injury, acute kidney injury (AKI), secondary infection and shock, will be described.
Measure: Number of subjects who develop complications of 2019-nCoV infection Time: 28 daysDescription: Virus shedding was detected twice at least a day apart.
Measure: Time to virus shedding Time: 28 daysDescription: improvement of chest radiographic evidence indirectly reflects recovery in patients infected with 2019-nCoV.
Measure: Time to improvement of abnormalities in Chest radiology Time: 28 daysDescription: The changes of TCM symptoms before and after treatment reveal the effect of TCM treatment for 2019-nCoV infection.
Measure: The evaluation of Traditional Chinese Medicine (TCM) symptoms before and after treatment Time: 28 daysDescription: The rate of subject who die will be described.
Measure: Rate of subjects who die Time: 28 daysDescription: The rate of subjects with severe 2019-nCoV infection who receive systematic corticosteroids will be described.
Measure: Rate of subjects receiving systematic corticosteroids Time: 28 daysDescription: The length of hospital stays
Measure: The length of hospital stays Time: 28 daysDescription: The duration of respiratory support including invasive and non-invasive mechanical ventilation
Measure: The duration of respiratory support Time: 28 daysThe SARS-CoV-2 infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. There is no confirmed antivirus therapy for people infected SARS-CoV-2, most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Mesenchymal Stem Cells (MSCs) therapy for pneumonia patients infected with SARS-CoV-2.
Description: Evaluation of Pneumonia Improvement
Measure: Size of lesion area by chest radiograph or CT Time: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21,Day 28Description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measure: Side effects in the MSCs treatment group Time: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180Description: Evaluation of Pneumonia Improvement
Measure: Improvement of Clinical symptoms including duration of fever and respiratory Time: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28Description: Marker for COVID-19
Measure: Time of nucleic acid turning negative Time: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180Description: Marker for efficacy of treatment
Measure: Rate of mortality within 28-days Time: Day 28Description: Marker of Immunological function
Measure: CD4+ and CD8+ T celll count Time: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180Description: Markers of organ function
Measure: Alanine aminotransferase Time: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180Description: Markers of Infection
Measure: C-reactive protein Time: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180Description: Markers of organ function
Measure: Creatine kinase Time: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia
Description: The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.
Measure: The critical illness rate of subjects at weeks 2 Time: 14 days after randomizationAt present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of two therapeutic schemes(abidol hydrochloride,abidol hydrochloride combined with interferon atomization)in the treatment of 2019-nCoV viral pneumonia, so as to provide reliable evidence-based medicine for the treatment of viral pneumonia caused by 2019-nCoV.
Description: A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2> 300mmHg (1mmHg=0.133Kpa);
Measure: Rate of disease remission Time: two weeksDescription: Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
Measure: Time for lung recovery Time: two weeksAt present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.
Description: A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2>300mmHg (1mmHg=0.133Kpa);
Measure: Rate of disease remission Time: two weeksDescription: Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
Measure: Time for lung recovery Time: two weeksDue 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 weeksIn the absence of 2019-ncov specific therapeutic drugs, arbidol is effective against a variety of coronaviruses in vitro pharmacodynamics. In order to observe the efficacy and safety of arbidol in the treatment of 2019-ncov infected pneumonia, this study is planned.
Description: virus negative conversion rate in second week, overall virus negative conversion rate
Measure: Virus negative conversion rate Time: 14-20 daysDescription: defined as: the rate of Axillary temperature ≤37.5 ℃ for at least 48h
Measure: Antipyretic rate Time: 14-20 daysDescription: time to relieve symptoms of fever, cough, dyspnea, myalgia, etc
Measure: Symptom relief time Time: 14-20 daysDescription: no adjuvant oxygen therapy, resting oxygen saturation>95%, oxygenation index>350
Measure: Finger oxygen improvement rate Time: 14-20 daysDescription: Mild, common type progression to severe or critical illness rate
Measure: Disease progression rate Time: 14-20 daysBased on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
Description: The definition of comprehensive adverse outcome is as follows: SPO2≤93% without oxygen inhalation; PaO2/FiO2≤300mmHg; RR≥30 bpm without oxygen inhalation.
Measure: Rate of comprehensive adverse outcome Time: 14 daysDescription: The definition of clinical remission: Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours; There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation).
Measure: Time of clinical remission Time: 28 daysIn this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.
Description: A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measure: Clinical improvement based on the 7-point scale Time: 28 days after randomizationDescription: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 7 days after randomizationDescription: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 14 days after randomizationDescription: Number of deaths during study follow-up
Measure: 28-day mortality Time: Measured from Day 0 through Day 28Description: Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Measure: Duration of mechanical ventilation Time: Measured from Day 0 through Day 28Description: Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Measure: Duration of hospitalization Time: Measured from Day 0 through Day 28Description: Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Measure: Proportion of patients with negative RT-PCR results Time: 7 and 14 days after randomizationDescription: Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measure: Proportion of patients in each category of the 7-point scale Time: 7,14 and 28 days after randomizationDescription: Proportion of patients with different inflammation factors in normalization range.
Measure: Proportion of patients with normalized inflammation factors Time: 7 and 14 days after randomizationDescription: Frequency of Adverse Drug Events
Measure: Frequency of Adverse Drug Events Time: Measured from Day 0 through Day 28Description: Frequency of Serious Adverse Drug Events
Measure: Frequency of Serious Adverse Drug Events Time: Measured from Day 0 through Day 28The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
Description: The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.
Measure: The critical illness rate of subjects at weeks 2 Time: 14 days after randomizationAt present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.
Description: For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2>93% or PaO2/FiO2 >300mmHg.
Measure: Rate of disease remission Time: day 7Description: the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.
Measure: Rate and time of entering the critical stage Time: day 7Description: Rate of patients without fever at day 7
Measure: Rate of normal tempreture Time: day 7Description: Rate of patients with respiratory symptom remission at day 7
Measure: Rate of respiratory symptom remission Time: day 7Description: Rate of patients with lung imaging recovery at day 7
Measure: Rate of lung imaging recovery Time: day 7Description: Rate of patients with laboratory indicator recovery at day 7
Measure: Rate of laboratory indicator recovery Time: day 7Description: Rate of patients withundetectable viral RNA at day 7
Measure: Rate of undetectable viral RNA Time: day 72019 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 enrollmentThe new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.
Description: TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
Measure: Time to Clinical Improvement (TTCI) Time: up to 28 daysDescription: on days 7, 14, 21, and 28
Measure: Clinical status assessed by the ordinal scale Time: up to 28 daysDescription: 1. No need for supplemental oxygenation; 2. nasal cathete oxygen inhalation;3. Mask oxygen inhalation;4. Noninvasive ventilator oxygen supply;5. Invasive ventilator oxygen supply.
Measure: The differences in oxygen intake methods Time: up to 28 daysDescription: The detection frequency could be increased according to clinician's decision
Measure: The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] Time: up to 28 daysDescription: The antibody titer is detected on days 3 and 28
Measure: Dynamic changes of 2019-nCoV antibody titer in blood Time: up to 28 daysSerious 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 enrollmentThere is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.
Description: The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.
Measure: the incidence of treatment failure in 14 days Time: 14 daysDescription: The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.
Measure: clinical cure incidence in 14 days Time: 14 daysDescription: the duration from admission to virus negative
Measure: the duration of virus change to negative Time: 30 daysDescription: the patient die in 30 days
Measure: mortality at day 30 Time: 30 daysDescription: the patients transform to ICU because of clinical deteriorate in 30 days
Measure: ICU admission rate in 30 days Time: 30 daysIn December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. This study is the first Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use immunomodulators to treat patients with COVID-19 infection.
Description: TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria: Fever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.
Measure: Time to Clinical recoveryTime to Clinical Recovery (TTCR) Time: up to 28 daysDescription: baseline SpO2 during screening, PaO2/FiO2 <300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen
Measure: All cause mortality Time: up to 28 daysDescription: Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Measure: Frequency of respiratory progression Time: up to 28 daysDescription: in those with fever at enrolment
Measure: Time to defervescence Time: up to 28 daysDescription: in those with cough at enrolment rated severe or moderate
Measure: Time to cough reported as mild or absent Time: up to 28 daysDescription: patients with moderate / severe dyspnea when enrolled
Measure: Respiratory improvement time Time: up to 28 daysThe novel coronavirus pneumonia is a kind of new emerging respiratory infectious disease, characterized by fever, dry cough, and chest tightness, and caused by the infection of the 2019 novel coronavirus (2019-nCoV). In severe cases, there will be rapid respiratory system failure. The novel coronavirus pneumonia is extremely contagious and the disease progresses rapidly. It has become a urgent and serious public health event that threatens human life and health globally. Among them, severe pneumonia caused by novel coronavirus is characterized by extensive acute inflammation of the lungs and the patient is critically ill. At present, there is no effective treatment in clinical practice.Most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for severe pneumonia patients infected with 2019-nCoV.
Description: Evaluation of Pneumonia Improvement
Measure: Pneumonia severity index Time: From Baseline (0W) to 12 week after treatmentDescription: Evaluation of Pneumonia Improvement
Measure: Oxygenation index (PaO2/FiO2) Time: From Baseline (0W) to 12 week after treatmentDescription: Incidence of acute and chronic treatment-related adverse events in patients with novel coronavirus severe pneumonia receiving UC-MSCs infusion as assessed.
Measure: Side effects in the UC-MSCs treatment group Time: From Baseline (0W) to 96 week after treatmentDescription: Marker for efficacy of treatment
Measure: 28-days survival Time: Day 28Description: Markers of organ function(Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.)
Measure: Sequential organ failure assessment Time: Day 28Description: Markers of Infection
Measure: C-reactive protein Time: From Baseline (0W) to 12 week after treatmentDescription: Markers of Infection
Measure: Procalcitonin Time: From Baseline (0W) to 12 week after treatmentDescription: Marker of Immunological function
Measure: Lymphocyte count Time: From Baseline (0W) to 12 week after treatmentDescription: Marker of Immunological function
Measure: CD3+, CD4+ and CD8+ T celll count Time: From Baseline (0W) to 12 week after treatmentDescription: Marker of Immunological function
Measure: CD4+/CD8+ratio Time: From Baseline (0W) to 12 week after treatmentCompare the efficacy and safety of Bromhexine Hydrochloride Tablets combined with standard treatment/ standard treatment in patients with suspected and mild, or common novel coronavirus pneumonia (COVID-19). Random, open, group sequential design.
Description: Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
Measure: Time to clinical recovery after treatment Time: within 14 days from the start of medicationDescription: Aggravation was defined as(one of them): respiratory distress, RR ≥ 30 times / min; SpO2 ≤ 93% in resting state; arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg
Measure: Rate of aggravation Time: within 14 days from the start of medicationDescription: Clinical remission was defined as (one of them): sustained (more than 48 hours) alleviation of illness based on symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) all being absent and no evidence for progression.
Measure: Clinical remission rate Time: within 14 days from the start of medicationDescription: oxygenation index
Measure: Dynamic changes of oxygenation index Time: within 14 days from the start of medicationDescription: time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
Measure: Time to cure Time: within 14 days from the start of medicationDescription: proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Measure: rate to cure Time: within 14 days from the start of medicationDescription: defervescence is defined as below 37 Celcius degrees(ear temperature)
Measure: Time to defervescence Time: within 14 days from the start of medicationTo evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.
Description: Virological clearance rate using Real-Time PCR in upper and/or lower respiratory tract samples at day 3, day 7 and day 14 respectively.
Measure: 2019 nCoV nucleic acid detection Time: 14 daysDescription: Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)
Measure: Recovery of body temperature Time: 14 daysDescription: Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)
Measure: Recovery of resting respiratory rate Time: 14 daysDescription: Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)
Measure: Recovery of SPO2 Time: 14 daysDescription: Rate of lung imaging recovery
Measure: Chest CT / chest film changes Time: 28 daysDescription: Rate of PaO2 / FiO2 recovery
Measure: PaO2 / FiO2 Time: 14 daysDescription: Days to reach the isolation release standard
Measure: Time to reach the isolation release standard Time: 28 daysDescription: Rate of CRP, D-Dimer test recovery
Measure: Changes of inflammatory immune status Time: 14 daysthe investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.
Description: From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours
Measure: Clinical recovery time Time: Up to Day 14Description: From the beginning of research drug use to body temperature <37.3 ℃ (underarm) or mouth temperature ≤37.5 ° C, or anal or ear temperature ≤37.8 ° C, and maintained for 24h or more
Measure: Complete fever time Time: Up to Day 14Description: Cough score "day + night" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above
Measure: Cough relief time Time: Up to Day 14Description: From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)
Measure: Virus negative time Time: Up to Day 14Description: Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia
Measure: Incidence of severe or critical neocoronavirus pneumonia Time: Up to Day 14The novel identified coronavirus (SARS-CoV-2) in 2019 causes an nationwide outbreak as well as public health crisis in China, and expands globally. Pulmonary edema is one of the most detrimental symptoms and usually presents in severe and critical coronavirus disease (COVID-19), resulting in dyspnea, acute lung injury (ALI) ,acute respiratory distress syndrome (ARDS), and even death. Recent evidence revealed higher levels of blood Vascular Endothelial Growth Factor (VEGF) in COVID-19 patients compared with healthy controls. VEGF is considered as the most potent vascular permeability inducers. Numerous studies have revealed that VEGF was a key factor and a potential therapeutic target in ALI and ARDS. Bevacizumab, an anti-VEGF drug, approved by the FDA on February 26, 2004 and widely used in clinical oncotherapy, is a promising drug for ALI/ARDS in COVID-19 through suppression of pulmonary edema.
Description: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio Time: 24 hoursDescription: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio Time: 72 hoursDescription: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio Time: 7 daysDescription: Liker scale: The patient grades his current breathing compared to when he first started the drug (from -3 to 3). "0" = no change, "1" =minimally better, "2" =moderately better, "3" =markedly better, "-1" =minimally worse, "-2" =moderately worse, "-3" =markedly worse
Measure: Degree of dyspnea (Liker scale) Time: 72 hoursDescription: The patient grades the current breathing condition of himself compared to when he first started the drug (from -3 to 3).
Measure: Degree of dyspnea (Liker scale) Time: 7 daysDescription: Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number "0" equals the worst breathing the patient has ever felt and the number "100" equals the best he has ever felt.
Measure: Degree of dyspnea (VAS) Time: 72 hoursDescription: Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number "0" equals the worst breathing the patient has ever felt and the number "100" equals the best he has ever felt.
Measure: Degree of dyspnea (VAS) Time: 7 daysDescription: The degree of exudation on Chest CT
Measure: The area of lung lesions on Chest CT Time: 7 daysDescription: The degree of lung exudation on Chest CT
Measure: The degree of lung exudation on Chest CT Time: 7 daysDescription: transcutaneous oxygen saturation
Measure: SpO2 Time: 24 hoursDescription: transcutaneous oxygen saturation
Measure: SpO2 Time: 72 hoursDescription: transcutaneous oxygen saturation
Measure: SpO2 Time: 7 daysDescription: Partial arterial oxygen pressure
Measure: PaO2 Time: 24 hoursDescription: Partial arterial oxygen pressure
Measure: PaO2 Time: 72 hoursDescription: Partial arterial oxygen pressure
Measure: PaO2 Time: 7 daysDescription: CRP
Measure: CRP Time: 72 hoursDescription: CRP
Measure: CRP Time: 7 daysDescription: hs-CRP
Measure: hs-CRP Time: 72 hoursDescription: hs-CRP
Measure: hs-CRP Time: 7 daysDescription: All-cause mortality
Measure: All-cause mortality Time: 7 daysDescription: All-cause mortality
Measure: All-cause mortality Time: 14 daysIn December 2019, a novel coronavirus infectious disease characterized by acute respiratory impairment due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan city of Hubei province in China. So far no specific antiviral therapy can be available for patients with SARS-CoV-2 infection. Although symptomatic and supportive care, even with mechanical ventilation or extracorporeal membrane oxygenation (ECMO), are strongly recommended for severe infected individuals, those with advancing age and co-morbidities such as diabetes and heart disease remain to be at high risk for adverse outcomes. This pilot clinical trial will be performed to explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in severe patients with novel coronavirus pneumonia (NCP).
Description: Safety evaluation within 28 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)
Measure: Adverse reaction (AE) and severe adverse reaction (SAE) Time: Up to 28 daysDescription: Efficiency evaluation within 28 days, including time to clinical improvement (TTIC)
Measure: Time to clinical improvement (TTIC) Time: Up to 28 daysDescription: Number of patients weaning from mechanical ventilation within 28 days
Measure: Number of patients weaning from mechanical ventilation Time: Up to 28 daysDescription: Duration (days) of ICU monitoring within 28 days
Measure: Duration (days) of ICU monitoring Time: Up to 28 daysDescription: Duration (days) of vasoactive agents using within 28 days
Measure: Duration (days) of vasoactive agents usage Time: Up to 28 daysDescription: Duration (days) of mechanical ventilation supply among survivors
Measure: Duration (days) of mechanical ventilation supply Time: Up to 28 daysDescription: Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs
Measure: Number of patients with improved organ failure Time: Up to 28 daysDescription: Rate of mortality within 28 days
Measure: Rate of mortality Time: Up to 28 daysDescription: Records of daily sequential organ failure assessment (SOFA) score (From 0 to 24 points, higher scores mean a worse outcome)
Measure: Sequential organ failure assessment (SOFA) score Time: Every day for 28 daysDescription: Records of Blood routine test
Measure: Lymphocyte Count (10E9/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Coagulation function
Measure: D-dimer (mg/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Records of heart failure
Measure: pro-type B natriuretic peptide (pro-BNP) (pg/ml) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Record of serum cytokine
Measure: IL-1β (pg/ml) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Record of serum cytokine
Measure: IL-2R (ng/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Record of serum cytokine
Measure: IL-6 (ng/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Record of serum cytokine
Measure: IL-8 (ng/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Computed tomography or X-ray
Measure: Chest imaging Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Time to SARS-CoV-2 RT-PCR negativity in respiratory tract specimens
Measure: Time to SARS-CoV-2 RT-PCR negativity Time: Up to 28 daysSince december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.
Description: Evaluation of pneumonia improvement
Measure: Improvement of clinical symptoms including duration of fever Time: Measured from day 0 through day 28Description: Evaluation of pneumonia improvement
Measure: Improvement of clinical symptoms including respiratory frequency Time: Measured from day 0 through day 28Description: Safety evaluation
Measure: Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0 Time: Measured from day 0 through day 28Description: Marker for 2019-nCoV
Measure: Time of virus nucleic acid test negative Time: Measured from day 0 through day 28Description: Marker of immunological function
Measure: CD4+ and CD8+ T cell count Time: Measured from day 0 through day 28Description: Marker for efficacy of treatment
Measure: Rate of mortality within 28-days Time: Day 28Description: Recovery of lung injury
Measure: Size of lesion area by thoracic imaging Time: Measured from day 0 through day 28Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.
Description: The screening accuracy of the two screening strategies were calculated and compared.
Measure: Screening accuracy Time: 1 monthDescription: The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.
Measure: Cost-effectiveness analysis Time: 1 monthThe acute lung injury caused by SARS and 2003 were both related to the inflammatory cytokine storm in patients. The biochemical test showed abnormal increase in related indicators such as interleukin-8, and CT images showed a medical "white" lung". According to the experience of SARS treatment in 2003, the use of hormones will indeed help the patients to alleviate their illness, but patients who survived SARS either had too much hormone at that time and took too long. Although the lungs could recover, but the femoral head was necrotic Either the amount of hormones was very conservative at the time, which kept the lungs in the storm of inflammatory factors, leading to the emergence of irreversible pulmonary fibrosis. So is there a medicine that can anti-inflammatory, reduce the load of hormone use, and have the effect of treating and preventing pulmonary fibrosis complicated by severe viral lung? At present, pirfenidone has achieved encouraging results in the treatment of idiopathic Pulmonary Fibrosis (CTD-ILD) diseases. It is particularly encouraging that the values announced at the 2019 ATS Annual Conference suggest that pirfenidone has more anti-inflammatory and anti-oxidant effects than its own outstanding anti-fibrotic ability. The data shows early use, Its strong anti-SOD activity can effectively inhibit IL-1beta and IL-4, and can open the prevention mode of pulmonary interstitial fibrosis. Based on the above, this project intends to make the following scientific assumptions: based on the homology of the pathogens of the new coronavirus-infected pneumonia and the coronavirus infection of pneumonia in 2003, the similarities in the occurrence and development of the disease, that is, the pulmonary inflammatory storm occurs first, and thereafter The progress of fibrosis and the progressive decline of lung function and mortality are higher than those of ordinary pneumonia. We hope that by adding pirfenidone as a treatment program in addition to standard treatment, it will be a new and severe type of coronavirus infection. Patient clinical treatment provides an effective and practical method.
Description: Lesion area of chest CT image at 4 weeks
Measure: chest CT Time: 4 weeksDescription: Absolute change in pulse oxygen from baseline
Measure: Finger pulse oxygen Time: 4 weeksDescription: Absolute change in blood gas from baseline
Measure: blood gas Time: 4 weeksDescription: Absolute change in total score of King's brief questionnaire for interstitial Absolute change in total score of King's brief questionnaire for interstitial pulmonary disease (k-bild) from baseline at week 4
Measure: K-BILD Time: 4 weeksDescription: Time to death within 4 weeks due to respiratory problems
Measure: death Time: 4 weeksDescription: Time to disease progression or death within 4 weeks
Measure: Time to disease progression or death within 4 weeks Time: 4 weeksDescription: lymphocyte count
Measure: blood Time: 4 weeksDescription: Absolute change in viral nucleic acid from baseline
Measure: viral nucleic acid Time: 4 weeksDescription: Pulmonary fibrosis survival symptoms absolute changes in dyspnea score from baseline
Measure: dyspnea score Time: 4 weeksDescription: changes in blood inflammatory indexes
Measure: blood Time: 4 weeksDescription: Absolute change in cough scores for pulmonary fibrosis survival symptoms from baseline
Measure: cough scores Time: 4 weeksTo develop practical and effective clinical diagnosis and treatment schemes for the control of novel coronavirus pneumonia.
Description: Number of patients recover from novel coronavirus pneumonia
Measure: recovery Time: up to 24 weeksWhile 2019-nCoV nucleic acid swab tests has high false positives rate, How to diagnose 2019-nCoV pneumonia and predict prognosis by CT is very important.In this retrospective single-center study, we consecutively included suspected 2019-nCoV pneumonia critical cases in the intensive care unit of Wuhan third hospital from January 31, 2020 to February 16, 2020. The cases were confirmed by real-time RT-PCR, and all patients were evaluated with CT, cutoff values were obtained according to the Yoden index, and were divided into high CT score group and low CT score group. Epidemiological, demographic, clinical, and laboratory data were collected.
This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.
Description: From screening to the end of treatment, for all patients randomized, oxygen saturation will be assessed for 3 times daily, the time to oxygen saturation recovery to normal level (≥97%) will be calculated finally based on that record and compared between two groups.
Measure: The time to oxygen saturation recovery to normal level (≥97%) Time: Day -1 to 10Description: The proportion of patients with normal level of oxygen saturation(≥97%) after treatment will be calculated finally based on that record and compared between two groups.
Measure: The proportion of patients with normal level of oxygen saturation(≥97%) Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the symptoms will be assessed 2 times daily, and the time to achievement of remission for each symptom will be calculated finally based on the record and compared between two groups.
Measure: The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc. Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal will be calculated finally based on the record and compared between two groups.
Measure: The time to the myocardial enzyme spectrum recovery to normal after treatment Time: Day -1, 3, 7 and 10Description: From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal myocardial enzyme spectrum after treatment will be calculated finally based on the record and compared between two groups.
Measure: The proportion of the patients with normal myocardial enzyme spectrum after treatment Time: Day -1, 3, 7 and 10Description: From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.
Measure: The time to the electrocardiogram recovery to normal level after treatment Time: Day -1, 3, 7 and 10Description: From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.
Measure: The proportion of the patients with normal electrocardiogram after treatment Time: Day -1, 3, 7 and 10Description: From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
Measure: The time to the hemodynamics recovery to normal after treatment Time: Day -1 and 10Description: From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
Measure: The proportion of the patients with normal hemodynamics after treatment Time: Day -1 and 10Description: From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
Measure: The time to exacerbation or remission of the disease after treatment; Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
Measure: The proportion of the patients with exacerbation or remission of disease after treatment Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
Measure: The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders Time: Day -1 to 10Description: For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
Measure: The all-cause mortality rate Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
Measure: The proportion of patients with acidosis Time: Day -1 and 10Description: For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
Measure: The total duration of the patients in-hospital Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measure: The total duration of oxygen inhalation during treatment Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measure: The oxygen flow rate during treatment Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measure: The oxygen concentration during treatment Time: Day -1 to 10The 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 daysEvaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Description: Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen
Measure: Rate of composite adverse outcomes Time: 14 daysDescription: Clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough, diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen).
Measure: Time to recovery Time: 14 daysDescription: Rate of no fever
Measure: Rate of no fever Time: 14 daysDescription: Rate of no cough
Measure: Rate of no cough Time: 14 daysDescription: Rate of no dyspnea
Measure: Rate of no dyspnea Time: 14 daysDescription: Rate of no requiring supplemental oxygen
Measure: Rate of no requiring supplemental oxygen Time: 14 daysDescription: Rate of undetectable New coronavirus pathogen nucleic acid
Measure: Rate of undetectable New coronavirus pathogen nucleic acid Time: 14 daysDescription: Rate of mechanical ventilation
Measure: Rate of mechanical ventilation Time: 14 daysDescription: Rate of ICU admission
Measure: Rate of ICU admission Time: 14 daysDescription: Rate of serious adverse event
Measure: Rate of serious adverse event Time: 14 daysObjects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types. Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19. Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19. Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.
Description: The mortality of COVID-19 in 28 days
Measure: Mortality Time: 28 dayDescription: The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.
Measure: The time interval of Nucleic acid detection become negative Time: 28 dayThe 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.
Description: Evaluation of Pneumonia change
Measure: Size of lesion area by chest imaging Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: Evaluation of Pneumonia change
Measure: Blood oxygen saturation Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: Marker for efficacy of treatment
Measure: Rate of mortality within 28-days Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: 0-4 score, the higher the score is, the poor of the prognosis will be.
Measure: Sequential organ failure assessment Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: Number of participants with treatment-related adverse events
Measure: Side effects in the UC-MSCs treatment group Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: Markers of the heart function
Measure: Electrocardiogram, the changes of ST-T interval mostly Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: Markers of infection
Measure: Concentration of C-reactive protein C-reactive protein, immunoglobulin Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: Marker of Immunology and inflammation
Measure: CD4+ and CD8+ T cells count Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: Marker of Immunology and inflammation
Measure: Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α) Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8Description: Markers of the heart function
Measure: Concentration of the myocardial enzymes Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.
Description: The time from study drug use to complete fever reduction and cough recovery is measured in hours.
Measure: Clinical recovery time Time: Up to Day 28To analyze the intubation with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.
Description: The data of Success rate of intubation with severe COVID-19 pneumonia patients
Measure: Success rate of intubation Time: the time span between 1hour before intubation and 24h after intubationDescription: Infection rate of Anesthesiologist who performed the endotracheal intubation for severe COVID-19 pneumonia patients
Measure: Infection rate of Anesthesiologist Time: the time span between 1hour before intubation and 14days after intubationDescription: Extubation time of intubated severe COVID-19 pneumonia patients
Measure: Extubation time Time: the time span between 1hour before intubation and 30days after intubationCurrently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a RNA virus that display high similarity in both genomic and proteomic profiling with SARS-CoV that first emerged in humans in 2003 in China. Therefore, preventing and controlling the pandemic occurrences are extremely urgent as a global top priority. Due to the lack of effective antiviral drugs, patients may be treated by only addressing their symptoms such as reducing fever. Clinical autopsies from SARS-CoV-infected patients demonstrated that there were major pathological changes in the lungs, immune organs, and small systemic blood vessels with vasculitis. However, the detection of SARS-CoV were primarily found in the lung and trachea/bronchus, but was undetectable in spleen, lymph nodes, bone marrow, heart and aorta, highlighting the overreaction of immune responses induced by viral infection were really harmful, resulting in the pathogenesis of lungs, immune organs, and small systemic blood vessels. To this respect, immune modulation strategy may be potentially beneficial to enhance anti-viral immunity and efficiently reduce the viral load, improve clinical outcomes, expedite the patient recovery, and decline the rate of mortality in patients after being infected with SARS-CoV-2. Tianhe Stem Cell Biotechnologies Inc. has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata (AA) and other autoimmune diseases. SCE therapy uses human multipotent cord blood stem cells (CB-SC) from human cord blood. Their properties distinguish CB-SC from other known stem cell types, including mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC). Several clinical studies show that SCE therapy functions via CB-SC induction of immune tolerance in autoimmune T cells and restore immune balance and homeostasis in patients with T1D, AA and other inflammation-associated diseases. To correct the overreaction of overreaction of immune responses, the investigators plan to treat SARS-CoV-2 patients with Stem Cell Educator therapy.
Description: The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.
Measure: Determine the number of Covid-19 patients who were unable to complete SCE Therapy Time: 4 weeksDescription: Measurements of immune markers' changes will be preformed by flow cytometry such as activated T cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Measure: Examine the percentage of activated T cells after SCE therapy by flow cytometry Time: 4 weeksDescription: Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Measure: Assess the percentage of Th17 cells after SCE therapy by flow cytometry Time: 4 weeksDescription: Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.
Measure: Chest imaging changes by computed tomography (CT) scan of the chest Time: 4 weeksDescription: To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy.
Measure: Quantification of the SARS-CoV-2 viral load by real time RT-PCR Time: 4 weeks