Covid 19 Research using Clinical Trials (Home Page)
HP:0011947: Respiratory tract infectionHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (10)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug980 | methylprednisolone therapy Wiki | 0.41 |
| drug539 | Naso pharyngeal swab Wiki | 0.41 |
| drug673 | Quick Defense Wiki | 0.41 |
| drug244 | DAS181 OL Wiki | 0.41 |
| drug243 | DAS181 COVID-19 Wiki | 0.41 |
| drug269 | Doxycycline Wiki | 0.29 |
| drug769 | Standard care Wiki | 0.20 |
| drug242 | DAS181 Wiki | 0.20 |
| drug582 | Oseltamivir Wiki | 0.18 |
| drug616 | Placebo Wiki | 0.08 |
There are 6 clinical trials
Clinical Trials
1 SEA022 Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection - a Clinical and Pharmacokinetic Study.
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.
NCT01546935 Influenza Drug: Oseltamivir MeSH:Infection Respiratory Tract Infections Influenza, Human
HPO:Respiratory tract infection
Primary Outcomes
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 days
Description: • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life
Measure: Pharmacokinetics of Oseltamivir Time: Day 0 and Day 9
Secondary Outcomes
Description: 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 days
Description: 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 days
Description: 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 days
2 Efficacy of Ingesting Gaia Herb's Quick Defense Product in Reducing Acute Respiratory Illness Symptomatology in Women: a 12-Week, Double Blind, Placebo-Controlled Randomized Trial
Primary Outcomes
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 9Secondary Outcomes
Description: 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 daysThe primary objective of this study is to evaluate the effectiveness of ingesting an alkylamide-rich echinacea root product (Quick Defense, Gaia Herbs) for 2 days immediately following each onset of acute respiratory illness (ARI) symptomatology during a 12-week period in the winter and early spring in women. Hypothesis: Subjects randomized to Quick Defense compared to placebo over a 12-week period will experience reduced ARI symptomatology, both acutely during each ARI episode and collectively over the entire 12-week study period.
NCT02003651 Acute Respiratory Infections Dietary Supplement: Quick Defense Dietary Supplement: Placebo MeSH:Respiratory Tract Infections
HPO:Respiratory tract infection
Primary Outcomes
Description: The Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess common cold illness severity and symptoms (see attached questionnaire). Subjects will fill in the one-page WURSS-24 at the end of each day during the 12-week monitoring period. This 12-week period will cover the winter and early spring period of 2014. From the responses recorded during the 84-day study, an ARI severity score will be calculated by summing the daily ARI global severity score (0=not sick, 1=very mild ARI to 7=severe). The ARI symptom score for the 84-day period will be calculated by summing all 10 symptom scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). In similar fashion, the ARI function ability score for the 84-day period will be calculated by summing all 9 function scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). Separate scores will be calculated comparing groups for each illness episode recorded by the subjects.
Measure: Common cold symptoms Time: 12-weeks
3 Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims.
Primary Outcomes
Description: The Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess common cold illness severity and symptoms (see attached questionnaire). Subjects will fill in the one-page WURSS-24 at the end of each day during the 12-week monitoring period. This 12-week period will cover the winter and early spring period of 2014. From the responses recorded during the 84-day study, an ARI severity score will be calculated by summing the daily ARI global severity score (0=not sick, 1=very mild ARI to 7=severe). The ARI symptom score for the 84-day period will be calculated by summing all 10 symptom scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). In similar fashion, the ARI function ability score for the 84-day period will be calculated by summing all 9 function scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). Separate scores will be calculated comparing groups for each illness episode recorded by the subjects.
Measure: Common cold symptoms Time: 12-weeksThe objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management. This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.
NCT02868541 Acute Respiratory Infection Other: Naso pharyngeal swab MeSH:Infection Respiratory Tract Infections
HPO:Respiratory tract infection
Primary Outcomes
Measure: The number of new viruses and/or bacteria identified and characterized by respiratory and pharyngeal carriage among pilgrims between the departure and the return of Hajj Time: up to 3 years
4 Trial of Respiratory Infections in Children for Enhanced Diagnostics
Primary Outcomes
Measure: The number of new viruses and/or bacteria identified and characterized by respiratory and pharyngeal carriage among pilgrims between the departure and the return of Hajj Time: up to 3 yearsThe 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
5 A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
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: 2021Description: Clinically relevant difference in MxA-levels between cases with viral clinical CAP and controls
Measure: Mxa viral clinical CAP and controls Time: 2021Description: Proportion of respiratory pathogens in cases and controls, using real time PCR
Measure: PCR - respiratory pathogens in cases and controls Time: 2020Description: Sensitivity and specificity for different respiratory viruses with MariPOC® Respi as compared to real-time PCR
Measure: Sensitivity and specificity - MariPOC Time: 2021Description: Sensitivity and specificity for different respiratory viruses with a novel PCR-based point-of-care test as compared to PCR
Measure: Sensitivity and specificity a novel PCR-based point-of-care test Time: 2021Description: Difference in asthma prevalence between cases and controls and difference in number of hospital-requiring respiratory infections between cases and controls after 3, 7 and 10 years
Measure: Difference asthma prevalence and number of hospital-requiring respiratory infections - cases and controls, Time: 2027Secondary 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: 2021Description: Clinically relevant differences in MxA-levels in cases with regard to specific respiratory agents
Measure: Specific assessment of MxA as a clinical biomarker Time: 2021Description: Sensitivity and specificity for MxA in identifying viral clinical CAP
Measure: Specific assessment of MxA as a clinical biomarker Time: 2021Description: Sensitivity and specificity for identifying viral and bacterial infection respectively for CRP, PCT and combination test of CRP, PCT and MxA
Measure: Specific assessment of MxA as a clinical biomarker Time: 2021Description: Difference in CRP and PCT between children with viral, bacterial, atypical bacterial and mixed viral-bacterial infection
Measure: Assessment of PCT and CRP as clinical biomarkers Time: 2021Description: Differences in symptom, antibiotic treatment, acute complications, radiologic exams admission rate and length of stay between cases with viral, bacterial, atypical bacterial and mixed viral-bacterial infection
Measure: Descriptive statistics of study cohort with regard to etiologic agent Time: 2020Description: Differences in symptom, antibiotic treatment, acute complications, radiologic exams admission rate and length of stay between cases who tested positive for respiratory virus by MariPOC® Respi as compared to those with a negative test
Measure: Evaluation of MariPOC® Respi in a clinical setting Time: 2022Description: Number of hospital-requiring respiratory infections in cases and controls
Measure: Assessment of long-term outcomes of children with CAP Time: 2027Description: Difference in asthma prevalence between cases with viral and bacterial clinical CAP as compared to an estimate of the prevalence in the general population
Measure: Assessment of long-term outcomes of children with CAP Time: 2027Description: Difference in proportion of hospital-requiring respiratory infections between cases with viral, bacterial, atypical and mixed viral-bacterial infection
Measure: Assessment of long-term outcomes of children with CAP Time: 2027Description: Difference in MxA-levels between PCR+/MariPOC® Respi+ and PCR+/MariPOC® Respi- study subjects.
Measure: Evaluation of MariPOC® Respi Time: 2022Description: Estimation of etiology of cases using two levels of certainty (definitive as well as probable definition).
Measure: Etiology of cases in TREND study Time: 2020This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.
NCT03808922 Lower Respiratory Tract Infection Parainfluenza Immunocompromised COVID-19 Drug: DAS181 Drug: Placebo Drug: DAS181 COVID-19 Drug: DAS181 OL MeSH:Infection Communicable Diseases Respiratory Tract Infections Paramyxoviridae Infections
HPO:Respiratory tract infection
Primary Outcomes
Description: Removal of all oxygen support (with stable SpO2)
Measure: Percent of subjects who Return to Room Air (RTRA) (main study) Time: by Day 28
Measure: Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study) Time: Day 14
Secondary Outcomes
Measure: All-cause mortality rate (main study) Time: at Day 28
Measure: Percent of subjects who Return to Room Air (RTRA) (main study) Time: by Day 21
Measure: Time (in days) to RTRA (main study) Time: Days 10, 14, 21, 28
Measure: Percent of subjects who achieve clinical stability (main study) Time: by Day 28
Measure: Percent of subjects discharged (without mortality and hospice) (main study) Time: by Days 14, 21, 28 and 35
Measure: Time (in days) to first hospital discharge (without hospice) (main study) Time: through Day 35
Measure: Total number of inpatient days (main study) Time: up to Day 35
Measure: Baseline SAD-RV infection-related mortality rate (main study) Time: at Day 28
Measure: Baseline SAD-RV infection-related mortality rate (main study) Time: at Day 35
Measure: All-cause mortality rate (main study) Time: at Day 35
Measure: Change in pulmonary function (FEV1% predicted) (main study) Time: Day 1, Day 7, Day 14, Day 28
Measure: Time to improved COVID19 clinical status (Sub-study) Time: Day 5, Day 10, Day 21, Day 28
Measure: Time to RTRA Time: Day 10, Day 14, Day 21, Day 28
Measure: Time to Clinical stability Time: Day 14, Day 21, Day 28
Measure: Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable Time: Day 5, Day 10, Day 14, Day 21, Day 28
Measure: Time to Clinical deterioration Time: Day 5, Day 10, Day 14, Day 21, Day 28
Measure: Time to Discharge from hospital (without readmission before Day 28). Time: Day 14, Day 21, Day 28
Measure: Time to Death (all causes) Time: Day 14, Day 21, Day 28
6 Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
Primary Outcomes
Description: Removal of all oxygen support (with stable SpO2)
Measure: Percent of subjects who Return to Room Air (RTRA) (main study) Time: by Day 28Measure: Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study) Time: Day 14
Secondary Outcomes
Measure: All-cause mortality rate (main study) Time: at Day 28Measure: Percent of subjects who Return to Room Air (RTRA) (main study) Time: by Day 21
Measure: Time (in days) to RTRA (main study) Time: Days 10, 14, 21, 28
Measure: Percent of subjects who achieve clinical stability (main study) Time: by Day 28
Measure: Percent of subjects discharged (without mortality and hospice) (main study) Time: by Days 14, 21, 28 and 35
Measure: Time (in days) to first hospital discharge (without hospice) (main study) Time: through Day 35
Measure: Total number of inpatient days (main study) Time: up to Day 35
Measure: Baseline SAD-RV infection-related mortality rate (main study) Time: at Day 28
Measure: Baseline SAD-RV infection-related mortality rate (main study) Time: at Day 35
Measure: All-cause mortality rate (main study) Time: at Day 35
Measure: Change in pulmonary function (FEV1% predicted) (main study) Time: Day 1, Day 7, Day 14, Day 28
Measure: Time to improved COVID19 clinical status (Sub-study) Time: Day 5, Day 10, Day 21, Day 28
Measure: Time to RTRA Time: Day 10, Day 14, Day 21, Day 28
Measure: Time to Clinical stability Time: Day 14, Day 21, Day 28
Measure: Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable Time: Day 5, Day 10, Day 14, Day 21, Day 28
Measure: Time to Clinical deterioration Time: Day 5, Day 10, Day 14, Day 21, Day 28
Measure: Time to Discharge from hospital (without readmission before Day 28). Time: Day 14, Day 21, Day 28
Measure: Time to Death (all causes) Time: Day 14, Day 21, Day 28
In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.
NCT04244591 COVID-19 Infections Drug: methylprednisolone therapy Other: Standard care MeSH:Infection
Primary Outcomes
Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 16 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 7 days after randomizationDescription: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 16 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 14 days after randomizationSecondary Outcomes
Description: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Measure: The difference of PaO2/FiO2 between two groups Time: 7 days after randomizationDescription: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Measure: Lower Sequential Organ Failure Assessment (SOFA) score Time: 7 days after randomizationDescription: Percentage of patients requiring Mechanical ventilation support
Measure: Mechanical ventilation support Time: 7 days after randomizationDescription: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Measure: The difference of PaO2/FiO2 between two groups Time: 14 days after randomizationDescription: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Measure: Lower Sequential Organ Failure Assessment (SOFA) score Time: 14 days after randomizationDescription: Percentage of patients requiring Mechanical ventilation support
Measure: Mechanical ventilation support Time: 14 days after randomizationDescription: Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
Measure: Clearance of noval coronavirus Time: 14 days after randomizationDescription: All-cause mortality
Measure: All-cause mortality Time: 30 days after randomization