CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


HP:0002090: PneumoniaHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (83)


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

Correlated MeSH Terms (16)


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

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0002098 Respiratory distress HPO 0.11
HP:0011947 Respiratory tract infection HPO 0.06

There are 42 clinical trials

Clinical Trials


1 Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

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.

NCT00043264 Multiple Sclerosis Drug: Rifampin Drug: Azithromycin
MeSH:Pneumonia Multiple Sclerosis Sclerosis
HPO:Pneumonia


2 The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia

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.

NCT02203110 Community Acquired Pneumonia Hospital Acquired Pneumonia Ventilator Associated Pneumonia
MeSH:Pneumonia, Ventilator-Associated Healthcare-Associated Pneumonia Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic

Time: each patient will be assessed at enrollment and follow-up for 2 months

3 The Place of Imaging and Microbiology in the Diagnosis of Pneumonia in the Elderly: PneumOldCT

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.

NCT02467192 Pneumonia Device: Low dose CT
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Number of upgraded or downgraded diagnoses

Time: During the 24 hours after CT

Secondary Outcomes

Measure: Number of bacterial and viral pulmonary infections

Time: During hospitalisation (maximum 3 months)

4 Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia

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.

NCT02517489 Community Acquired Pneumonia Drug: Hydrocortisone Drug: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Day 28 all causes mortality

Time: at day 28

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 21

Secondary Outcomes

Measure: In patients non-invasively ventilated at inclusion, proportion of patients needing endotracheal intubation

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: In patients non-ventilated at inclusion, proportion of patients requiring non-invasive ventilation

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: In patients non-ventilated at inclusion, proportion of patients needing endotracheal intubation

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: Day 28 ventilator-free-days

Time: between 0 and day 28

Measure: Number of patients with vasopressor therapy initiation from inclusion to day 28

Time: between 0 and day 28

Measure: Day 28 vasopressor-free-days

Time: between 0 and day 28

Measure: ICU and/or intermediate care unit LOS

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: All-causes mortality at day 90

Time: at day 90

Measure: SF-36 Health Survey at day 90

Time: at day 90

Measure: Biomarkers: procalcitonin at baseline, day 3 and day 7

Time: at inclusion, day 3 and day 7

Measure: Biomarkers: C-reactive protein at baseline, day 3 and day 7

Time: at inclusion, day 3 and day 7

Measure: Biomarkers: plasmatic concentration of pro-inflammatory cytokines (IL-6, IL-20, IL-22, IL-22BP, HBD2, TNF) at baseline, day 3 and day 7

Time: at inclusion, day 3 and day 7

Measure: P/F ratio measured daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28

Time: measured daily from baseline to day 7, at the end of treatment i.e 14 days after the start of treatment, at the end of ICU-stay (for a maximum of 28 days) and/or day 28

Measure: SOFA calculated daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28

Time: calculated daily from baseline to day 7, at the end of treatment (i.e 14 days after the start of treatment), at the end of ICU-stay (for a maximum of 28 days) and/or day 28

Measure: Proportion of patients experiencing secondary infection during their ICU-stay

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: Proportion of patients experiencing gastrointestinal bleeding during their ICU-stay

Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

Measure: Daily amount of insulin administered to the patient from day 1 to day 7

Time: Patients will be followed from day 1 to day 7

Measure: Weight-gain at baseline and day 7

Time: Patients will be followed at baseline and day 7

Other Outcomes

Description: 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-stay

Description: Sub-group of patients included with COVID19

Measure: Proportion of patients needing endotracheal intubation

Time: at day 21

Description: Sub-group of patients included with COVID19

Measure: Proportion of patients experiencing secondary infection during their ICU-stay

Time: From baseline to day 21

5 Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

REMAP-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.

NCT02735707 Community-acquired Pneumonia, Influenza, COVID-19 Drug: Fixed-duration Hydrocortisone Drug: Shock-dependent hydrocortisone Drug: Ceftriaxone Drug: Moxifloxacin or Levofloxacin Drug: Piperacillin-tazobactam Drug: Ceftaroline Drug: Amoxicillin-clavulanate Drug: Macrolide administered for 3-5 days Drug: Macrolide administered for up to 14 days Drug: Five-days oseltamivir Drug: Ten-days oseltamivir Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: Hydroxychloroquine + lopinavir/ritonavir Drug: Interferon-β1a Drug: Anakinra Drug: Fixed-duration higher dose Hydrocortisone Drug: Tocilizumab Drug: Sarilumab
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: All-cause mortality

Time: Day 90

Description: Primary end-point for patients with suspected or proven COVID-19 pandemic infection

Measure: Days alive and outside of ICU

Time: Day 21

Secondary Outcomes

Measure: ICU Mortality

Time: Day 90

Measure: ICU length of stay

Time: Day 90

Measure: Hospital length of stay

Time: Day 90

Measure: Ventilator free days

Time: Day 28

Measure: Organ failure free days

Time: Day 28

Measure: All-cause mortality

Time: 6 months

Description: EQ5D-5L and WHODAS 2.0 (not completed in all regions)

Measure: Health-related Quality of life assessment

Time: 6 months

Measure: Proportion of intubated patients who receive a tracheostomy

Time: Day 28

Description: 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 90

Measure: Readmission to the index ICU during the index hospitalization

Time: Day 90

Measure: World Health Organisation 8-point ordinal scale outcome

Time: Hospital discharge

Other Outcomes

Description: Antibiotic Domain specific outcome

Measure: Occurrence of multi-resistant organism colonisation/infection

Time: Day 90, censored at hospital discharge

Description: Antibiotic Domain specific outcome

Measure: Occurrence clostridium difficile

Time: Day 90, censored at hospital discharge

Description: 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 discharge

Description: 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 7

Description: 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 discharge

6 Trial of Respiratory Infections in Children for Enhanced Diagnostics

The 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.

NCT03233516 Community-acquired Pneumonia
MeSH:Respiratory Tract Infections Pneumonia
HPO:Pneumonia Respiratory tract infection

Primary Outcomes

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: 2021

Description: Clinically relevant difference in MxA-levels between cases with viral clinical CAP and controls

Measure: Mxa viral clinical CAP and controls

Time: 2021

Description: Proportion of respiratory pathogens in cases and controls, using real time PCR

Measure: PCR - respiratory pathogens in cases and controls

Time: 2020

Description: Sensitivity and specificity for different respiratory viruses with MariPOC® Respi as compared to real-time PCR

Measure: Sensitivity and specificity - MariPOC

Time: 2021

Description: 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: 2021

Description: 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: 2027

Secondary Outcomes

Description: 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: 2021

Description: Clinically relevant differences in MxA-levels in cases with regard to specific respiratory agents

Measure: Specific assessment of MxA as a clinical biomarker

Time: 2021

Description: Sensitivity and specificity for MxA in identifying viral clinical CAP

Measure: Specific assessment of MxA as a clinical biomarker

Time: 2021

Description: 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: 2021

Description: 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: 2021

Description: 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: 2020

Description: 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: 2022

Description: Number of hospital-requiring respiratory infections in cases and controls

Measure: Assessment of long-term outcomes of children with CAP

Time: 2027

Description: 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: 2027

Description: 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: 2027

Description: Difference in MxA-levels between PCR+/MariPOC® Respi+ and PCR+/MariPOC® Respi- study subjects.

Measure: Evaluation of MariPOC® Respi

Time: 2022

Description: Estimation of etiology of cases using two levels of certainty (definitive as well as probable definition).

Measure: Etiology of cases in TREND study

Time: 2020

7 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections

Non 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.

NCT03331445 Respiratory Tract Infections Corona Virus Infection Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
MeSH:Inf Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases
HPO:Respiratory tract infection

Primary Outcomes

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 Days

Secondary Outcomes

Description: 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 26

Description: 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 26

Description: 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 26

Other Outcomes

Description: 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 26

Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

Description: Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract

Measure: Antiviral effect

Time: Day 26

Description: Time to clinical recovery as measured by resolution of clinical signs

Measure: Efficacy on clinical improvement

Time: Day 26

Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26

8 Effects of Traditional Chinese Medicines (TCMs) on Patients With 2019-nCoV Infection: A Perspective, Open-labeled, Randomized, Controlled Trial

The 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.

NCT04251871 Pneumonia Caused by Human Coronavirus (Disorder) Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir)
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Symptoms associated with 2019-nCoV infection involve fever and cough.

Measure: Time to complete remission of 2019-nCoV infection-associated symptoms

Time: 28 days

Secondary Outcomes

Description: 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 days

Description: 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 days

Description: Virus shedding was detected twice at least a day apart.

Measure: Time to virus shedding

Time: 28 days

Description: 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 days

Description: 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 days

Other Outcomes

Description: The rate of subject who die will be described.

Measure: Rate of subjects who die

Time: 28 days

Description: 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 days

Description: The length of hospital stays

Measure: The length of hospital stays

Time: 28 days

Description: The duration of respiratory support including invasive and non-invasive mechanical ventilation

Measure: The duration of respiratory support

Time: 28 days

9 Safety and Efficiency of Mesenchymal Stem Cell in Treating Pneumonia Patients Infected With COVID-19

The 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.

NCT04252118 COVID-19 Biological: MSCs
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 28

Description: 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 180

Secondary Outcomes

Description: 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 28

Description: 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 180

Description: Marker for efficacy of treatment

Measure: Rate of mortality within 28-days

Time: Day 28

Description: 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 180

Description: 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 180

Description: 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 180

Description: 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 180

10 Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19

The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia

NCT04252274 Pneumonia, Pneumocystis Coronavirus Drug: Darunavir and Cobicistat
MeSH:Pneumonia, Pneumocystis Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7

Time: 7 days after randomization

Secondary Outcomes

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3

Time: 3 days after randomization

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5

Time: 5 days after randomization

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: 14 days after randomization

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 randomization

Measure: The mortality rate of subjects at weeks 2

Time: 14 days after randomization

11 An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Two Therapeutic Schemes(Abidol Hydrochloride,Abidol Hydrochloride Combined With Interferon Atomization)in the Treatment of 2019-nCoV Pneumonia.

At 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.

NCT04254874 2019-nCoV Drug: Abidol hydrochloride Drug: Abidol Hydrochloride combined with Interferon atomization
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 weeks

Description: Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.

Measure: Time for lung recovery

Time: two weeks

Secondary Outcomes

Measure: Rate of no fever

Time: two weeks

Measure: Rate of respiratory symptom remission

Time: two weeks

Measure: Rate of lung imaging recovery

Time: two weeks

Measure: Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery

Time: two weeks

Measure: Rate of undetectable viral RNA

Time: two weeks

12 An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Three Antiviral Drugs(Abidol Hydrochloride, Oseltamivir and Lopinavir/Ritonavir) in the Treatment of 2019-nCoV Pneumonia.

At 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.

NCT04255017 2019-nCoV Drug: Abidol hydrochloride Drug: Oseltamivir Drug: Lopinavir/ritonavir
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 weeks

Description: Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.

Measure: Time for lung recovery

Time: two weeks

Secondary Outcomes

Measure: Rate of no fever

Time: two weeks

Measure: Rate of respiratory symptom remission

Time: two weeks

Measure: Rate of lung imaging recovery

Time: two weeks

Measure: Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery

Time: two weeks

Measure: Rate of undetectable viral RNA

Time: two weeks

13 A Survey of Psychological Status of Medical Workers and Residents in the Context of 2019 Novel Coronavirus Pneumonia in Wuhan, China

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.

NCT04260308 Virus; Pneumonia
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

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 weeks

Secondary Outcomes

Description: 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 weeks

14 Randomized, Open, Multicenter Study on the Efficacy and Safety of Arbidol Hydrochloride Tablets in Treating Pneumonia in Patients Infected With Novel Coronavirus (2019-ncov).

In 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.

NCT04260594 2019-nCoV Drug: Arbidol Other: basic treatment
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Virus negative conversion rate in the first week

Time: first week

Secondary Outcomes

Description: virus negative conversion rate in second week, overall virus negative conversion rate

Measure: Virus negative conversion rate

Time: 14-20 days

Description: defined as: the rate of Axillary temperature ≤37.5 ℃ for at least 48h

Measure: Antipyretic rate

Time: 14-20 days

Description: time to relieve symptoms of fever, cough, dyspnea, myalgia, etc

Measure: Symptom relief time

Time: 14-20 days

Description: no adjuvant oxygen therapy, resting oxygen saturation>95%, oxygenation index>350

Measure: Finger oxygen improvement rate

Time: 14-20 days

Description: Mild, common type progression to severe or critical illness rate

Measure: Disease progression rate

Time: 14-20 days

Measure: Mortality rate

Time: 14-20 days

Measure: Incidence of severe adverse reactions

Time: 14-20 days

Measure: Change curve of peripheral blood lymphocyte count

Time: 14-20 days

15 A Randomized,Open,Controlled Small Sample Clinical Study to Evaluate the Efficacy and Safety of ASC09/Ritonavir Compound Tablets and Ritonavir for 2019-nCoV Pneumonia

Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.

NCT04261270 2019-nCoV Pneumonia Drug: ASC09F+Oseltamivir Drug: Ritonavir+Oseltamivir Drug: Oseltamivir
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 days

Secondary Outcomes

Description: 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 days

Measure: Rate of no fever

Time: 14 days

Measure: Rate of no cough

Time: 14 days

Measure: Rate of no dyspnea

Time: 14 days

Measure: Rate of no need for oxygen inhalation

Time: 14 days

Measure: Rate of undetectable viral RNA

Time: 14 days

Measure: Rate of mechanical ventilation

Time: 28 days

Measure: Rate of ICU admission

Time: 28 days

Measure: Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery

Time: 28 days

16 A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia

In 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.

NCT04261426 2019-nCoV Drug: Intravenous Immunoglobulin Other: Standard care
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 randomization

Description: 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 randomization

Description: 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 randomization

Secondary Outcomes

Description: Number of deaths during study follow-up

Measure: 28-day mortality

Time: Measured from Day 0 through Day 28

Description: 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 28

Description: Days that a participant spent at the hospital. Multiple hospitalizations are summed up.

Measure: Duration of hospitalization

Time: Measured from Day 0 through Day 28

Description: 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 randomization

Description: 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 randomization

Description: Proportion of patients with different inflammation factors in normalization range.

Measure: Proportion of patients with normalized inflammation factors

Time: 7 and 14 days after randomization

Description: Frequency of Adverse Drug Events

Measure: Frequency of Adverse Drug Events

Time: Measured from Day 0 through Day 28

Description: Frequency of Serious Adverse Drug Events

Measure: Frequency of Serious Adverse Drug Events

Time: Measured from Day 0 through Day 28

17 Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.

NCT04261517 Pneumonia, Pneumocystis Coronavirus COVID-19 Drug: Hydroxychloroquine
MeSH:Pneumonia, Pneumocystis Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3

Time: 3 days after randomization

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5

Time: 5 days after randomization

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7

Time: 7 days after randomization

Measure: The mortality rate of subjects at weeks 2

Time: 14 days after randomization

Secondary Outcomes

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: 14 days after randomization

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 randomization

18 An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia

At 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.

NCT04263402 2019-nCoV Severe Pneumonia Drug: Methylprednisolone Drug: Methylprednisolone
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 7

Description: 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 7

Secondary Outcomes

Description: Rate of patients without fever at day 7

Measure: Rate of normal tempreture

Time: day 7

Description: Rate of patients with respiratory symptom remission at day 7

Measure: Rate of respiratory symptom remission

Time: day 7

Description: Rate of patients with lung imaging recovery at day 7

Measure: Rate of lung imaging recovery

Time: day 7

Description: Rate of patients with laboratory indicator recovery at day 7

Measure: Rate of laboratory indicator recovery

Time: day 7

Description: Rate of patients withundetectable viral RNA at day 7

Measure: Rate of undetectable viral RNA

Time: day 7

19 Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia: a Prospective Randomized Clinical Trial

2019 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.

NCT04264533 Vitamin C Pneumonia, Viral Pneumonia, Ventilator-Associated Drug: VC Drug: Sterile Water for Injection
MeSH:Pneumonia, Ventilator-Associated Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: days without ventilation support during 28 days after patients' enrollment

Measure: Ventilation-free days

Time: on the day 28 after enrollment

Secondary Outcomes

Description: wether the patient survives

Measure: 28-days mortality

Time: on the day 28 after enrollment

Description: days of the patients staying in the ICU

Measure: ICU length of stay

Time: on the day 28 after enrollment

Description: the rate of CPR

Measure: Demand for first aid measuments

Time: on the day 28 after enrollment

Description: days of using vasopressors

Measure: Vasopressor days

Time: on the day 28 after enrollment

Description: P O2/Fi O2 which reflects patients' respiratory function

Measure: Respiratory indexes

Time: on the day 10 and 28 after enrollment

Description: Ecmo or ventilator

Measure: Ventilator parameters

Time: on the day 10 and 28 after enrollment

Description: Acute Physiology and Chronic Health Evaluation

Measure: APACHE II scores

Time: on the day 10 after enrollment

Description: Sepsis-related Organ Failure Assessment

Measure: SOFA scores

Time: on the day 10 after enrollment

20 An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients

The 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.

NCT04264858 2019-nCoV Immunoglobulin of Cured Patients Drug: Immunoglobulin of cured patients Drug: γ-Globulin
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 days

Secondary Outcomes

Description: on days 7, 14, 21, and 28

Measure: Clinical status assessed by the ordinal scale

Time: up to 28 days

Description: 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 days

Measure: Duration (days) of supplemental oxygenation

Time: up to 28 days

Measure: Duration (days) of mechanical ventilation

Time: up to 28 days

Measure: The mean PaO2/FiO2

Time: up to 28 days

Description: 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 days

Measure: Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]

Time: up to 28 days

Description: The antibody titer is detected on days 3 and 28

Measure: Dynamic changes of 2019-nCoV antibody titer in blood

Time: up to 28 days

Measure: Length of hospital stay (days)

Time: up to 28 days

Measure: All cause mortality

Time: up to 28 days

21 Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection

Serious 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.

NCT04269525 Pneumonia, Viral Pneumonia, Ventilator-Associated Biological: UC-MSCs
MeSH:Pneumonia, Ventilator-Associated Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)

Measure: Oxygenation index

Time: on the day 14 after enrollment

Secondary Outcomes

Description: whether the patient survives

Measure: 28 day mortality

Time: on the day 28 after enrollment

Description: days of the patients in hospital

Measure: Hospital stay

Time: up to 6 months

Description: 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 enrollment

Description: whether lung imaging examinations show the improvement of the pneumonia

Measure: Improvement of lung imaging examinations

Time: on the day 7,14,28 after enrollment

Description: counts of white blood cell in a litre of blood

Measure: White blood cell count

Time: on the day 7,14,28 after enrollment

Description: counts of lymphocyte in a litre (L) of blood

Measure: Lymphocyte count

Time: on the day 7,14,28 after enrollment

Description: percentage of lymphocyte in white blood cell

Measure: Lymphocyte percentage

Time: on the day 7,14,28 after enrollment

Description: procalcitonin in microgram(ug)/L

Measure: Procalcitonin

Time: on the day 7,14,28 after enrollment

Description: IL-2 in picogram(pg)/millilitre(mL)

Measure: interleukin(IL)-2

Time: on the day 7,14,28 after enrollment

Description: IL-4 in pg/mL

Measure: IL-4

Time: on the day 7,14,28 after enrollment

Description: IL-6 in pg/mL

Measure: IL-6

Time: on the day 7,14,28 after enrollment

Description: IL-8 in pg/mL

Measure: IL-8

Time: on the day 7,14,28 after enrollment

Description: IL-10 in pg/mL

Measure: IL-10

Time: on the day 7,14,28 after enrollment

Description: TNF-α in nanogram(ng)/L

Measure: tumor necrosis factor(TNF)-α

Time: on the day 7,14,28 after enrollment

Description: γ-IFN in a thousand unit (KU)/L

Measure: γ-interferon(IFN)

Time: on the day 7,14,28 after enrollment

22 Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails

There 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.

NCT04273321 COVID-19 Novel Coronavirus Pneumonia Drug: Methylprednisolone
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 days

Secondary Outcomes

Description: 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 days

Description: the duration from admission to virus negative

Measure: the duration of virus change to negative

Time: 30 days

Description: the patient die in 30 days

Measure: mortality at day 30

Time: 30 days

Description: the patients transform to ICU because of clinical deteriorate in 30 days

Measure: ICU admission rate in 30 days

Time: 30 days

23 The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study

In 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.

NCT04273529 COVID-19 Thalidomide Drug: thalidomide Drug: placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 days

Secondary Outcomes

Description: 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 days

Description: 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 days

Description: in those with fever at enrolment

Measure: Time to defervescence

Time: up to 28 days

Other Outcomes

Description: in those with cough at enrolment rated severe or moderate

Measure: Time to cough reported as mild or absent

Time: up to 28 days

Description: patients with moderate / severe dyspnea when enrolled

Measure: Respiratory improvement time

Time: up to 28 days

Measure: Frequency of requirement for supplemental oxygen or non-invasive ventilation

Time: up to 28 days

Measure: Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen

Time: up to 28 days

Measure: Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve

Time: up to 28 days

Measure: Frequency of requirement for mechanical ventilation

Time: up to 28 days

Measure: Frequency of serious adverse events

Time: up to 28 days

Measure: Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10,MCP1, MIP1α and other cytokine expression levels before and after treatment

Time: up to 28 days

24 Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19

The 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.

NCT04273646 2019 Novel Coronavirus Pneumonia COVID-19 Biological: UC-MSCs Drug: Placebo
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluation of Pneumonia Improvement

Measure: Pneumonia severity index

Time: From Baseline (0W) to 12 week after treatment

Description: Evaluation of Pneumonia Improvement

Measure: Oxygenation index (PaO2/FiO2)

Time: From Baseline (0W) to 12 week after treatment

Secondary Outcomes

Description: 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 treatment

Description: Marker for efficacy of treatment

Measure: 28-days survival

Time: Day 28

Description: 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 28

Description: Markers of Infection

Measure: C-reactive protein

Time: From Baseline (0W) to 12 week after treatment

Description: Markers of Infection

Measure: Procalcitonin

Time: From Baseline (0W) to 12 week after treatment

Description: Marker of Immunological function

Measure: Lymphocyte count

Time: From Baseline (0W) to 12 week after treatment

Description: Marker of Immunological function

Measure: CD3+, CD4+ and CD8+ T celll count

Time: From Baseline (0W) to 12 week after treatment

Description: Marker of Immunological function

Measure: CD4+/CD8+ratio

Time: From Baseline (0W) to 12 week after treatment

25 Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)

Compare 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.

NCT04273763 Novel Coronavirus Pneumonia 2019-nCoV Drug: Bromhexine Hydrochloride Tablets Drug: Arbidol Hydrochloride Granules Drug: Recombinant Human Interferon α2b Spray
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

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 medication

Description: 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 medication

Secondary Outcomes

Description: 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 medication

Description: oxygenation index

Measure: Dynamic changes of oxygenation index

Time: within 14 days from the start of medication

Description: 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 medication

Description: 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 medication

Description: defervescence is defined as below 37 Celcius degrees(ear temperature)

Measure: Time to defervescence

Time: within 14 days from the start of medication

Measure: Time to cough remission

Time: within 14 days from the start of medication

Measure: Time to dyspnea remission

Time: within 14 days from the start of medication

Measure: Days of supplemental oxygenation

Time: within 14 days from the start of medication

Measure: Rate of patients with requring supplemental oxygen

Time: within 14 days from the start of medication

Measure: Rate of patients with mechanical ventilation

Time: within 14 days from the start of medication

Measure: Time of negative COVID-19 nucleic acid results

Time: within 14 days from the start of medication

Measure: Rate of negative COVID-19 nucleic acid results

Time: within 14 days from the start of medication

Measure: Rate of ICU admission

Time: within 14 days from the start of medication

Measure: 28-day mortality

Time: From the first day of screening to the day of follow-up (28 days)

26 Single Center, Single Arm, Open Clinical Study to Access Safety and Initial Efficacy of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia

To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.

NCT04275245 2019-nCoVs Infection Pneumonia Drug: Meplazumab for Injection
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 days

Secondary Outcomes

Description: Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)

Measure: Recovery of body temperature

Time: 14 days

Description: Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)

Measure: Recovery of resting respiratory rate

Time: 14 days

Description: Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)

Measure: Recovery of SPO2

Time: 14 days

Description: Rate of lung imaging recovery

Measure: Chest CT / chest film changes

Time: 28 days

Description: Rate of PaO2 / FiO2 recovery

Measure: PaO2 / FiO2

Time: 14 days

Description: Days to reach the isolation release standard

Measure: Time to reach the isolation release standard

Time: 28 days

Description: Rate of CRP, D-Dimer test recovery

Measure: Changes of inflammatory immune status

Time: 14 days

27 A Prospective, Randomized, Open, Parallel Controlled, Multicenter Clinical Study of Xiyanping Injection in Combination With Conventional Treatment for the Evaluation of the Effectiveness and Safety of Novel Coronavirus Infection Pneumonia

the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.

NCT04275388 2019 Novel Coronavirus Pneumonia Drug: Xiyanping injection Drug: Lopinavir / ritonavir, alpha-interferon nebulization
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

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 14

Secondary Outcomes

Description: 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 14

Description: 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 14

Description: 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 14

Description: 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 14

28 A Pilot Study of Bevacizumab in the Treatment of Severe or Critical Patients With COVID-19 Pneumonia (BEST-CP)

The 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.

NCT04275414 Coronavirus Infections Drug: Bevacizumab Injection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

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 hours

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: 72 hours

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: 7 days

Secondary Outcomes

Description: 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 hours

Description: 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 days

Description: 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 hours

Description: 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 days

Description: The degree of exudation on Chest CT

Measure: The area of lung lesions on Chest CT

Time: 7 days

Description: The degree of lung exudation on Chest CT

Measure: The degree of lung exudation on Chest CT

Time: 7 days

Description: transcutaneous oxygen saturation

Measure: SpO2

Time: 24 hours

Description: transcutaneous oxygen saturation

Measure: SpO2

Time: 72 hours

Description: transcutaneous oxygen saturation

Measure: SpO2

Time: 7 days

Description: Partial arterial oxygen pressure

Measure: PaO2

Time: 24 hours

Description: Partial arterial oxygen pressure

Measure: PaO2

Time: 72 hours

Description: Partial arterial oxygen pressure

Measure: PaO2

Time: 7 days

Description: CRP

Measure: CRP

Time: 72 hours

Description: CRP

Measure: CRP

Time: 7 days

Description: hs-CRP

Measure: hs-CRP

Time: 72 hours

Description: hs-CRP

Measure: hs-CRP

Time: 7 days

Description: All-cause mortality

Measure: All-cause mortality

Time: 7 days

Description: All-cause mortality

Measure: All-cause mortality

Time: 14 days

29 A Pilot Clinical Study on Aerosol Inhalation of the Exosomes Derived From Allogenic Adipose Mesenchymal Stem Cells in the Treatment of Severe Patients With Novel Coronavirus Pneumonia

In 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).

NCT04276987 Coronavirus Biological: MSCs-derived exosomes
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

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 days

Description: Efficiency evaluation within 28 days, including time to clinical improvement (TTIC)

Measure: Time to clinical improvement (TTIC)

Time: Up to 28 days

Secondary Outcomes

Description: Number of patients weaning from mechanical ventilation within 28 days

Measure: Number of patients weaning from mechanical ventilation

Time: Up to 28 days

Description: Duration (days) of ICU monitoring within 28 days

Measure: Duration (days) of ICU monitoring

Time: Up to 28 days

Description: Duration (days) of vasoactive agents using within 28 days

Measure: Duration (days) of vasoactive agents usage

Time: Up to 28 days

Description: Duration (days) of mechanical ventilation supply among survivors

Measure: Duration (days) of mechanical ventilation supply

Time: Up to 28 days

Description: 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 days

Description: Rate of mortality within 28 days

Measure: Rate of mortality

Time: Up to 28 days

Other Outcomes

Description: 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 days

Description: Records of Blood routine test

Measure: Lymphocyte Count (10E9/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Measure: C-reactive protein (CRP) (mg/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Measure: Lactate dehydrogenase (U/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Coagulation function

Measure: D-dimer (mg/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: 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 available

Description: Record of serum cytokine

Measure: IL-1β (pg/ml)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-2R (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-6 (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-8 (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Computed tomography or X-ray

Measure: Chest imaging

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: 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 days

30 Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus

Since 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.

NCT04280224 Novel Coronavirus Pneumonia Biological: NK Cells
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluation of pneumonia improvement

Measure: Improvement of clinical symptoms including duration of fever

Time: Measured from day 0 through day 28

Description: Evaluation of pneumonia improvement

Measure: Improvement of clinical symptoms including respiratory frequency

Time: Measured from day 0 through day 28

Description: Safety evaluation

Measure: Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0

Time: Measured from day 0 through day 28

Secondary Outcomes

Description: Marker for 2019-nCoV

Measure: Time of virus nucleic acid test negative

Time: Measured from day 0 through day 28

Description: Marker of immunological function

Measure: CD4+ and CD8+ T cell count

Time: Measured from day 0 through day 28

Description: Marker for efficacy of treatment

Measure: Rate of mortality within 28-days

Time: Day 28

Description: Recovery of lung injury

Measure: Size of lesion area by thoracic imaging

Time: Measured from day 0 through day 28

31 Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Since 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.

NCT04281693 Novel Coronavirus Infection Pneumonia Diagnostic Test: Standard screening strategy Diagnostic Test: New screening strategy
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The screening accuracy of the two screening strategies were calculated and compared.

Measure: Screening accuracy

Time: 1 month

Secondary Outcomes

Description: The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.

Measure: Cost-effectiveness analysis

Time: 1 month

32 A Randomized, Open-label Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Severe and Critical Novel Coronavirus Infection

The 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.

NCT04282902 Novel Coronavirus Pneumonia Pneumonia Pirfenidone Drug: pirfenidone
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Lesion area of chest CT image at 4 weeks

Measure: chest CT

Time: 4 weeks

Description: Absolute change in pulse oxygen from baseline

Measure: Finger pulse oxygen

Time: 4 weeks

Description: Absolute change in blood gas from baseline

Measure: blood gas

Time: 4 weeks

Description: 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 weeks

Secondary Outcomes

Description: Time to death within 4 weeks due to respiratory problems

Measure: death

Time: 4 weeks

Description: Time to disease progression or death within 4 weeks

Measure: Time to disease progression or death within 4 weeks

Time: 4 weeks

Description: lymphocyte count

Measure: blood

Time: 4 weeks

Description: Absolute change in viral nucleic acid from baseline

Measure: viral nucleic acid

Time: 4 weeks

Description: Pulmonary fibrosis survival symptoms absolute changes in dyspnea score from baseline

Measure: dyspnea score

Time: 4 weeks

Description: changes in blood inflammatory indexes

Measure: blood

Time: 4 weeks

Description: Absolute change in cough scores for pulmonary fibrosis survival symptoms from baseline

Measure: cough scores

Time: 4 weeks

33 Study for Clinical Epidemiology and Methods of Diagnosis and Treatment of Novel Coronavirus Pneumonia (NCP)

To develop practical and effective clinical diagnosis and treatment schemes for the control of novel coronavirus pneumonia.

NCT04283396 Novel Coronavirus Pneumonia Combination Product: systemic treatment
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Number of patients recover from novel coronavirus pneumonia

Measure: recovery

Time: up to 24 weeks

34 CT Scores Predict Mortality in 2019-nCoV Pneumonia

While 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.

NCT04284046 CT Scores Predict Mortality in 2019-nCoV Pneumonia Other: CT score
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: 7-day mortality

Time: 7-day

35 A Clinical Study to Investigate the Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With Coronavirus Disease 2019 (COVID-19)

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.

NCT04285190 Coronavirus Disease 2019 Novel Coronavirus Pneumonia Drug: T89
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

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 10

Description: 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 10

Secondary Outcomes

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

Description: 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 10

36 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial

The 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.

NCT04290858 Coronavirus Infections Pneumonia, Viral Dyspnea Drug: Nitric Oxide
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Dyspnea
HPO:Dyspnea Pneumonia Respiratory distress

Primary Outcomes

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 days

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

Description: 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 days

Description: 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 days

37 An Open Clinical Trial to Evaluate Ganovo(Danoprevir ) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.

NCT04291729 COVID-19 Drug: Ganovo+ritonavir+/-Interferon nebulization
MeSH:Infection

Primary Outcomes

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 days

Secondary Outcomes

Description: 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 days

Description: Rate of no fever

Measure: Rate of no fever

Time: 14 days

Description: Rate of no cough

Measure: Rate of no cough

Time: 14 days

Description: Rate of no dyspnea

Measure: Rate of no dyspnea

Time: 14 days

Description: Rate of no requiring supplemental oxygen

Measure: Rate of no requiring supplemental oxygen

Time: 14 days

Description: Rate of undetectable New coronavirus pathogen nucleic acid

Measure: Rate of undetectable New coronavirus pathogen nucleic acid

Time: 14 days

Description: Rate of mechanical ventilation

Measure: Rate of mechanical ventilation

Time: 14 days

Description: Rate of ICU admission

Measure: Rate of ICU admission

Time: 14 days

Description: Rate of serious adverse event

Measure: Rate of serious adverse event

Time: 14 days

38 Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)

Objects: 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.

NCT04292327 Pneumonia Caused by Human Coronavirus
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The mortality of COVID-19 in 28 days

Measure: Mortality

Time: 28 day

Description: 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 day

39 Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus

The 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.

NCT04293692 COVID-19 Biological: UC-MSCs Other: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 8

Description: Evaluation of Pneumonia change

Measure: Blood oxygen saturation

Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

Secondary Outcomes

Description: Marker for efficacy of treatment

Measure: Rate of mortality within 28-days

Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: Marker of Immunology and inflammation

Measure: CD4+ and CD8+ T cells count

Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

Description: 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 8

Description: Markers of the heart function

Measure: Concentration of the myocardial enzymes

Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

40 Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

In 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.

NCT04295551 COVID-19 Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection Drug: Lopinavir/ritonavir treatment
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

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 28

41 Analysis of Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia

To 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.

NCT04298814 COVID-19 Endotracheal Intubation Other: severe covid-19 pneumonia with ET
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 intubation

Description: 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 intubation

Secondary Outcomes

Description: Extubation time of intubated severe COVID-19 pneumonia patients

Measure: Extubation time

Time: the time span between 1hour before intubation and 30days after intubation

42 Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Currently, 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.

NCT04299152 Severe Acute Respiratory Syndrome (SARS) Pneumonia Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome Inflammation
HPO:Pneumonia

Primary Outcomes

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 weeks

Secondary Outcomes

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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


HPO Nodes