Name (Synonyms) | Correlation | |
---|---|---|
drug1132 | Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) Wiki | 0.41 |
drug2102 | Ritonavir+Oseltamivir Wiki | 0.41 |
drug2588 | Umbilical Cord Mesenchymal Stem Cells Wiki | 0.41 |
drug2888 | mesenchymal stem cells Wiki | 0.41 |
drug2693 | Wharton's jelly derived Mesenchymal stem cells. Wiki | 0.41 |
drug80 | ASC09F+Oseltamivir Wiki | 0.41 |
drug2836 | hormones Wiki | 0.41 |
drug2939 | oxygen therapy Wiki | 0.29 |
drug103 | Abidol hydrochloride Wiki | 0.29 |
drug262 | Azithromycin Wiki | 0.14 |
drug1372 | Lopinavir/ritonavir Wiki | 0.13 |
drug1086 | Hydroxychloroquine Wiki | 0.04 |
Name (Synonyms) | Correlation | |
---|---|---|
D007251 | Influenza, Human NIH | 0.12 |
D012141 | Respiratory Tract Infections NIH | 0.09 |
D011014 | Pneumonia NIH | 0.07 |
D016638 | Critical Illness NIH | 0.06 |
D013577 | Syndrome NIH | 0.05 |
D055371 | Acute Lung Injury NIH | 0.04 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.04 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
D007239 | Infection NIH | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0011947 | Respiratory tract infection HPO | 0.09 |
HP:0002090 | Pneumonia HPO | 0.07 |
There are 6 clinical trials
Currently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one. There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.
Description: Viral clearance on Day 5 (human influenza) on a throat swab, assessed by RT PCR. Viral clearance on Day 10 (avian influenza) on a throat swab, assessed by RT PCR.
Measure: Viral clearance Time: 5-10 daysDescription: • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life
Measure: Pharmacokinetics of Oseltamivir Time: Day 0 and Day 9Description: Time to viral clearance on a throat swab, assessed by RT PCR. The time to no detectable influenza virus by culture for the throat swab. Change in viral load (log10 copies/mL) over time for all virological samples (lower limit of detection: 1000 copies/mL) Viral susceptibility of cultured influenza virus to antiviral drugs at baseline and post treatment, assessed by genotypical and phenotypical analyses
Measure: Viral end points Time: 5-10 daysDescription: Time to fever clearance In hospital mortality and mortality by follow up Time to death Time to trans cutaneous O2 saturation of ≥ 95% on room air Clinical course: pneumothorax, encephalitis/encephalopathy Number of days in hospital Number of days ventilated
Measure: Clinical Efficacy Endpoints Time: 5-10 daysDescription: Documented serious adverse events (SAEs) and relationships to oseltamivir AEs leading to drug withdrawal Grade 3 & 4 clinical and laboratory AEs that are probably or definitely related to oseltamivir Skin rashes of any grade Changes in haematological and biochemical parameters over time
Measure: Safety Endpoints Time: 5-10 daysAt present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.
Description: A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2>300mmHg (1mmHg=0.133Kpa);
Measure: Rate of disease remission Time: two weeksDescription: Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
Measure: Time for lung recovery Time: two weeksBased on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
Description: The definition of comprehensive adverse outcome is as follows: SPO2≤93% without oxygen inhalation; PaO2/FiO2≤300mmHg; RR≥30 bpm without oxygen inhalation.
Measure: Rate of comprehensive adverse outcome Time: 14 daysDescription: The definition of clinical remission: Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours; There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation).
Measure: Time of clinical remission Time: 28 daysTo evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).
Description: The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u
Measure: Laboratory Result Time: Day 07 on follow-upDescription: The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below: Not hospitalized, able to resume normal activities Not hospitalized, but unable to resume normal activities Hospitalization, not requiring supplemental oxygen Hospitalization, requiring supplemental oxygen Hospitalization, requiring noninvasive mechanical ventilation Hospitalization, requiring invasive mechanical ventilation Death
Measure: Clinical Outcome Time: Day 07 on follow-upThe outbreak of coronavirus disease 2019 (COVID-19) at the end of 2019 has seen numerous patients experiencing severe acute lung injury (ALI), which developed into severe respiratory distress syndrome (ARDS). The mortality was as high as 20% -40%. Due to the lack of effective antiviral treatments, supporting treatment is the predominant therapy for COVID-19 pneumonia. Its cure is essentially dependent on the patient's immunity. While the immune system eliminates the virus, numerous inflammatory cytokines are produced and a cytokine storm occurs in severe cases. Mesenchymal stem cells (MSCs) play an important role in injury repair and immune regulation, showing advantageous prospects in the treatment of COVID-19 pneumonia. MSCs prevent cytokine storms by retarding the TNF-α pathway, alleviate sepsis by modulating macrophages, neutrophils, NK cells, DC cells, T lymphocytes and B lymphocytes. After infused, MSCs aggregate in the lungs, improve the lung microenvironment, protect alveolar epithelia, and improve pulmonary fibrosis and pulmonary function.
Description: Improvement of pulmonary function
Measure: Changes of oxygenation index (PaO2/FiO2) ,blood gas test Time: 12 monthsDescription: Cytokines level
Measure: Detection of TNF-α levels, IL-10 levels Time: 1,3,6,12monthsDescription: Immunological status
Measure: Detection of immune cells that secret cytokines, including CXCR3+, CD4+, CD8+, NK+ cells, and regulatory T cells (CD4 + CD25 + FOXP3 + Treg cells). Time: 1,3,6,12monthsDescription: Improvement of pulmonary function
Measure: Changes of oxygenation index (PaO2/FiO2) ,blood gas test Time: 1,3,6monthsDescription: Infection biomarkers
Measure: Changes of c-reactive protein and calcitonin Time: 1,3,6,12monthsNovel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.
Description: Assessing whether the patients still have dyspnea, one of cardinal symptoms of Covid-19, assessed from the respiratory rate
Measure: Clinical improvement: Presence of dyspnea Time: 15 daysDescription: Assessing whether the patients still have productive cough, one of cardinal symptoms of Covid-19, assessed from lung auscultation
Measure: Clinical improvement: presence of sputum Time: 15 daysDescription: Assessing the presence of fever from measurement of body temperature checking, assessed on daily basis
Measure: Clinical improvement: fever Time: 15 daysDescription: Assessing whether the patients still require ventilation, one of cardinal symptoms of ARDS in Covid-19, assessed from patients' ability during ventilation weaning phase
Measure: Clinical improvement: ventilation status Time: 15 daysDescription: Assessing the patients' blood pressure on daily basis
Measure: Clinical improvement: blood pressure Time: 15 daysDescription: Assessing the patients' heart rate on daily basis
Measure: Clinical improvement: heart rate Time: 15 daysDescription: Assessing the patients' respiratory rate on daily basis
Measure: Clinical improvement: respiratory rate Time: 15 daysDescription: Assessing the patients' oxygen saturation on daily basis
Measure: Clinical improvement: oxygen saturation Time: 15 daysDescription: Assessing the changes in total leukocyte upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from leukocyte level Time: 15 daysDescription: Assessing the changes in lymphocytes level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from lymphocytes level Time: 15 daysDescription: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood pH Time: 15 daysDescription: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of CO2 Time: 15 daysDescription: Assessing the changes in blood base excess level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood base excess level Time: 15 daysDescription: Assessing the changes in blood oxygen partial pressure upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood oxygen partial pressure Time: 15 daysDescription: Assessing the changes in blood level of HCO3 upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of HCO3 Time: 15 daysDescription: Assessing the changes in blood level of O2 saturation upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of O2 saturation Time: 15 daysDescription: Assessing the changes in level of CRP, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from level of CRP Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of SGOT/SGPT (AST/ALT) level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from level of SGOT/SGPT (AST/ALT) Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of ureum/creatinine level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of ureum/creatinine level Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of eGFR, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of eGFR Time: 15 daysDescription: Assessing the changes in level of sodium, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of sodium Time: 15 daysDescription: Assessing the changes in level of potassium, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of potassium Time: 15 daysDescription: Assessing the changes in level of chloride, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of chloride Time: 15 daysDescription: Assessing the changes in procalcitonin level to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in procalcitonin level Time: 15 daysDescription: Assessing the changes in albumin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from albumin level Time: 15 daysDescription: Assessing the changes in total bilirubin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from total bilirubin level Time: 15 daysDescription: Assessing the changes in D-Dimer to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in D-Dimer level Time: 15 daysDescription: Assessing the changes in fibrinogen to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in fibrinogen level Time: 15 daysDescription: Assessing the changes in troponin level to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Cardiac changes from troponin level Time: 15 daysDescription: Assessing the changes in NT proBNP to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Cardiac changes from NT proBNP level Time: 15 daysDescription: Assessing the changes in leukemia inhibiting factor (LIF) to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in Leukemia Inhibiting Factor Time: 7 daysDescription: Assessing the changes in level of IL-6 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of IL-6 Time: 7 daysDescription: Assessing the changes in level of IL-10 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of IL-10 Time: 7 daysDescription: Assessing the changes in vascular endothelial growth factor (VEGF) to assess the effect of growth factors in the MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of vascular endothelial growth factor (VEGF) Time: 7 daysDescription: Assessing the changes in level of ferritin to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of ferritin Time: 7 daysDescription: Assessing the changes in level of CXCR3 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CXCR3 Time: 7 daysDescription: Assessing the changes in level of CD4 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD4 Time: 7 daysDescription: Assessing the changes in level of CD8 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD8 Time: 7 daysDescription: Assessing the changes in CD56 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD56 Time: 7 daysDescription: Assessing the changes in radiology examination (Chest X-Ray/CT Scan) for any increased in lung infiltration or ground glass opacity, assessed prior to implantation and once every 3 days post-implantation
Measure: Radiologic Improvement from Chest X-Ray/CT Scan Time: 15 days