CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D012141: Respiratory Tract Infections NIH

(Synonyms: Respiratory Tract Infe, Respiratory Tract Infec, Respiratory Tract Infect, Respiratory Tract Infections)

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


Correlated Drug Terms (28)


Name (Synonyms) Correlation
drug166 CYNK-001 Wiki 0.26
drug539 Naso pharyngeal swab Wiki 0.26
drug230 Convalescent plasma Wiki 0.26
drug1037 trimethoprim/sulfamethoxazole Wiki 0.26
drug673 Quick Defense Wiki 0.26
drug785 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Wiki 0.26
drug244 DAS181 OL Wiki 0.26
drug784 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Wiki 0.26
drug786 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Wiki 0.26
drug377 Hydroxychloroquine Sulfate + Azithromycin Wiki 0.26
drug252 Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days Wiki 0.26
drug619 Placebo 250 cc 24 hours continuous infusion for 15 days Wiki 0.26
drug160 COVSurf Drug Delivery System Wiki 0.26
drug787 Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki 0.26
drug833 Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals Wiki 0.26
drug553 Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki 0.26
drug243 DAS181 COVID-19 Wiki 0.26
drug269 Doxycycline Wiki 0.18
drug21 ACE inhibitor Wiki 0.18
drug330 HB-adMSCs Wiki 0.18
drug242 DAS181 Wiki 0.13
drug582 Oseltamivir Wiki 0.12
drug46 Anakinra Wiki 0.10
drug771 Standard of Care Wiki 0.09
drug375 Hydroxychloroquine Sulfate Wiki 0.08
drug616 Placebo Wiki 0.08
drug632 Placebos Wiki 0.07
drug360 Hydroxychloroquine Wiki 0.03

Correlated MeSH Terms (20)


Name (Synonyms) Correlation
D007154 Immune System Diseases NIH 0.26
D007239 Infection NIH 0.19
D003141 Communicable Diseases NIH 0.18
D030341 Nidovirales Infections NIH 0.18
D003139 Common Cold NIH 0.18
D012327 RNA Virus Infections NIH 0.18
D003333 Coronaviridae Infections NIH 0.15
D011665 Pulmonary Valve Insufficiency NIH 0.15
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.15
D018184 Paramyxoviridae Infections NIH 0.15
D008173 Lung Diseases, Obstructive NIH 0.13
D008171 Lung Diseases, NIH 0.13
D012140 Respiratory Tract Diseases NIH 0.10
D007251 Influenza, Human NIH 0.10
D045169 Severe Acute Respiratory Syndrome NIH 0.09
D000860 Hypoxia NIH 0.09
D014777 Virus Diseases NIH 0.08
D018352 Coronavirus Infections NIH 0.07
D011014 Pneumonia NIH 0.07
D011024 Pneumonia, Viral NIH 0.04

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0011947 Respiratory tract infection HPO 0.53
HP:0002090 Pneumonia HPO 0.08

There are 15 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

The 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.

The 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

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

5 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

6 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

This 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

7 Awareness Between Pregnant Women Regarding Corona Virus

Corona virus is known as covid 19 And is transmitted through droplet infection

NCT04317365 Respiratory Tract Infections
MeSH:Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Description: The number of pregnant women who have awareness about the disease

Measure: The number of pregnant women who know the exact symptoms of the disease

Time: Within one month

8 Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals

Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting

NCT04321369 Infections, Respiratory Fever Cough Diagnostic Test: Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals
MeSH:Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Description: compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting

Measure: Accuracy of patient administered tests

Time: 2 weeks

9 The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective? An Analysis Using UK Based Electronic Health Records of 5.6 Million Individuals.

The study use UK based linked electronic health records from the Clinical Research Datalink (CALIBER) of 5.6 million individuals to conduct a matched case-control study to investigate the incidence of influenza in individuals prescribed ACEI compared to those not prescribed ACEI.

NCT04322786 Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom Drug: ACE inhibitor
MeSH:Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Measure: Incidence of influenza

Time: Jan 1st 1998 - May 31st 2016

10 Audio Data Collection for Identification and Classification of Coughing

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

NCT04326309 COVID-19 Coronavirus Infections Hay Fever Asthma Chronic Obstructive Pulmonary Disease Influenza Common Cold Respiratory Tract Infections Healthy
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Common Cold Severe Acute Respiratory Syndrome Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
HPO:Chronic obstructive pulmonary disease Obstructive lung disease Respiratory tract infection

Primary Outcomes

Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Measure: Dataset size

Time: 14 days

Secondary Outcomes

Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

Measure: Cough sound identification

Time: 14 days

Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

Measure: Improvement of the existing model

Time: 14 days

Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

Measure: Evaluate the usability of the application

Time: 14 days

11 Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

NCT04332991 Coronavirus Acute Respiratory Infection SARS-CoV Infection Drug: Hydroxychloroquine Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: We will determine the COVID Ordinal Scale for all patients on study day 15 COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)

Measure: COVID Ordinal Outcomes Scale on Day 15

Time: assessed on study day 15

Secondary Outcomes

Description: Vital status of the patient on day 15 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

Measure: all-location, all-cause mortality assessed on day 15

Time: assessed on study day 15

Description: Vital status of the patient at day 28 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

Measure: all-location, all-cause mortality assessed on day 29

Time: assessed on study day 29

Description: We will determine the COVID Ordinal Scale for all patients on study day 3

Measure: COVID Ordinal Outcomes Scale on Study Day 3

Time: assessed on study day 3

Description: We will determine the COVID Ordinal Scale on study day 8

Measure: COVID Ordinal Outcomes Scale on Study Day 8

Time: assessed on study day 8

Description: We will determine the COVID Ordinal Scale on study day 29

Measure: COVID Ordinal Outcomes Scale on Study Day 29

Time: assessed on study day 29

Description: We will determine the number of patients who are either dead or on ECMO ( extracorporeal membrane oxygenation) between enrollment and day 28

Measure: Number of patients dead or with receipt of ECMO between enrollment and Day 28

Time: Enrollment to Day 28

Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of oxygen therapy. Patients who die prior to day 28 are assigned zero oxygen free days.

Measure: Oxygen-free days through Day 28

Time: 28 days after randomization

Description: Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.

Measure: Ventilator-free days through Day 28

Time: 28 days after randomization

Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 are assigned zero vasopressor free days.

Measure: Vasopressor-free days through Day 28

Time: 28 days after randomization

Description: The number of days spent out of the ICU to day 28.

Measure: ICU-free days to Day 28

Time: 28 days after randomization

Description: Defined as 28 days minus the number of days from randomization to discharge home.If a patient has not been discharged home prior to day 28 or dies prior to day 28, hospital free days will be zero.

Measure: Hospital-free days to Day 28

Time: 28 days after randomization

Other Outcomes

Description: We will determine the number of patients that experience seizure between randomization and day 28

Measure: Number of patients with seizures to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience ventricular arrhythmia between randomization and day 28

Measure: Number of patients with atrial or ventricular arrhythmia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience cardiac arrest between randomization and day 28

Measure: Number of patients with cardiac arrest to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal between randomization and day 28

Measure: Number of patients with elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience acute pancreatitis between randomization and day 28

Measure: Number of patients with acute pancreatitis arrest to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience acute kidney injury between randomization and day 28

Measure: Number of patients with acute kidney injury to day28

Time: 28 days after randomization

Description: We will determine the number of patients that experience renal replacement therapy between randomization and day 28

Measure: Number of patients with receipt of renal replacement therapy to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience symptomatic hypoglycemia between randomization and day 28

Measure: Number of patients with symptomatic hypoglycemia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience neutropenia, lymphopenia, anemia, or thrombocytopenia between randomization and day 28

Measure: Number of patients with neutropenia, lymphopenia, anemia, or thrombocytopenia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience severe dermatologic reaction between randomization and day 28

Measure: Number of patients with severe dermatologic reaction to day 28

Time: 28 days after randomization

12 An Open Randomized Study of the Effectiveness of the Drug Dalargin for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)

The purpose of the study is to evaluate an effectiveness of the drug Dalargin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ). Test drug that will be administered to patients are: - Dalargin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.

NCT04346693 Acute Respiratory Tract Infection Acute Respiratory Insufficiency Pneumonia Septic Shock Hypoxemia Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation
MeSH:Infection Respiratory Tract Infections Pneumonia Respiratory Insufficiency Pulmonary Valve Insufficiency Hypoxia
HPO:Hypoxemia Pneumonia Pulmonary insufficiency Respiratory tract infection

Primary Outcomes

Description: Estimated by Polymerase chain reaction (PCR)

Measure: The change of viral load in patients with SARS-COVID-19.

Time: Upon patient inclusion in the study, after 96 hours and on the 10day;

Description: Assessed through the entire patient participation in the study

Measure: The frequency of development of Acute Respiratory Distress Syndrome (ADRS)

Time: up to 8 months

Description: The number of days a patient is hospitalized

Measure: Duration of hospitalization

Time: through study completion, an average of 8 months

Description: Early mortality from all causes will be estimated

Measure: The frequency of early mortality

Time: up to 30 days

Description: Late mortality from all causes will be estimated

Measure: The frequency of late mortality

Time: up to 90 days

Description: Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: Death; Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; Hospitalization extended, on non-invasive ventilation; Hospitalization is extended, needs additional oxygen; Hospitalization is extended, additional oxygen is not required; Discharged.

Measure: Clinical status at the time of completion of participation in the study

Time: through study completion, an average of 8 months

13 suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial

In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure. Also due to the potential co-existing immunodysfunction in the context of SARS-CoV-2 infection patients will also receive trimethoprim/sulfamethoxazole as part of chemoprophylaxis.

NCT04357366 COVID-19 Virus Diseases Co Corona Virus Infection Lower Respiratory Tract Infection Viral Drug: Anakinra Drug: trimethoprim/sulfamethoxazole
MeSH:Infection Communicable Di Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Virus Diseases
HPO:Respiratory tract infection

Primary Outcomes

Description: The primary study endpoint is the ratio of patients who will not develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered non-achieving the primary endpoint.

Measure: The ratio of patients who will not develop serious respiratory failure (SRF)

Time: Visit study day 14

Secondary Outcomes

Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of the rate of patients who will not develop serious respiratory failure (SRF) until day 14 with historical comparators from Hellenic Sepsis Study Group Database

Time: Visit study day 14

Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7

Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14

Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14

Time: Visit study day 1, visit study day 14

Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of SOFA score in enrolled subjects between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14

Time: Visit study day 1, visit study day 14

Description: Change of cytokine stimulation from peripheral blood mononuclear cells of enrolled subjects will be compared between days 1 and 7

Measure: Change of cytokine production between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7

Measure: Change of plasma inflammatory mediators levels between days 1 and 7

Time: Visit study day 1, visit study day 7

14 A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19

Lung surfactant is present in the lungs. It covers the alveolar surface where it reduces the work of breathing and prevents the lungs from collapsing. In some respiratory diseases and in patients that require ventilation this substance does not function normally. This study will introduce surfactant to the patients lungs via the COVSurf Drug Delivery System

NCT04362059 Respiratory Infections Device: COVSurf Drug Delivery System Other: Standard of Care
MeSH:Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Description: To assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio after treatment with study treatment

Measure: Oxygenation Improvement

Time: 3 months

Description: To assess the improvement in pulmonary ventilation as determined by the Ventilation Index (VI), where VI = [RR x (PIP − PEEP) × PaCO2]/1000 after study treatment.

Measure: Pulmonary ventilation Improvement

Time: 3 months

Secondary Outcomes

Description: To assess safety as judged by the frequency and severity of adverse events and severe adverse events (SAEs).

Measure: Safety Assessment of Frequency and Severity of Adverse Events

Time: 3 months

15 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in hospitalized patients with moderate COVID-19 disease.

NCT04365101 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia Pneumonia, Viral Lung Diseases Respiratory Tract Disease Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Disease Immunologic Disease ARDS Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-infective Agents Analgesics Antimetabolites, Antineoplastic Biological: CYNK-001
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Pneumonia, Viral Coronaviridae Infections Nidovir Nidovirales Infections Pneumonia Lung Diseases Virus Diseases Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Pneumonia Respiratory tract infection

Primary Outcomes

Description: Number and severity of adverse events

Measure: Phase 1: Frequency and Severity of Adverse Events (AE)

Time: Up to 12 months

Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR

Measure: Time to Clearance of SARS-CoV-2

Time: Up to 12 months

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Rate of Clearance of SARS-CoV-2

Time: Up to 12 months

Description: Time from the date of randomization to the first date of clinical improvement of cough.

Measure: Time to Clinical Improvement of cough

Time: Up to 28 days

Description: Time from the date of randomization to the first date of clinical improvement of fever

Measure: Time to Clinical Improvement of fever

Time: Up to 28 days

Description: Time from the date of randomization to the first date of clinical improvement of radiological evaluation of disease related chest x-ray

Measure: Time to Clinical Improvement in radiological evaluation of disease related chest x-ray

Time: Up to 28 days

Description: Proportion of subjects who achieved clinical improvement of fever

Measure: Rate of Clinical Improvement of fever

Time: Up to 28 days

Description: Proportion of subjects who achieved clinical improvement of cough

Measure: Rate of Clinical Improvement of cough

Time: Up to 28 days

Description: Proportion of subjects who achieved clinical improvement of radiological evaluation of disease related chest x-ray

Measure: Rate of Clinical Improvement of radiological evaluation of disease related chest x-ray

Time: Up to 28 days

Description: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).

Measure: Time to Pulmonary Clearance

Time: Up to 28 days

Description: Proportion of subjects who achieve pulmonary clearance

Measure: Rate of Pulmonary Clearance

Time: Up to 28 days

Description: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.

Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score

Time: Up to 28 days

Secondary Outcomes

Description: Number and severity of adverse events

Measure: Phase 2: Frequency and Severity of Adverse Events (AE)

Time: up to 12 months

Description: Time to medical discharge as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by time to medical discharge

Time: up to 12 months

Description: Hospital utilization will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by hospital utilization

Time: up to 12 months

Description: Mortality rate will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by measuring mortality rate

Time: up to 12 months


HPO Nodes


HP:0011947: Respiratory tract infection
Genes 633
TIMM8A DNAH9 SIK1 ARID1B NFKBIA GTF2H5 IER3IP1 TNFRSF11A GUSB TBC1D24 BIRC3 IL17RA SPAG1 MSN WDR34 CTSC GAS2L2 NIPBL BTK NFKB1 FCGR3A CRELD1 IGLL1 RNF168 ZBTB24 STAT3 RFX5 TAF1 MKRN3 PLEC CFTR IRAK4 COLQ DNAAF4 TCTN3 MYO9A TGFB1 LEPR SLC18A3 TAP2 LAMA2 PEPD NGLY1 CFAP300 WAS DNAI1 TBCD DNAAF2 SELENON IL2RG IRAK4 ARMC4 SOX4 RSPH1 IFNGR1 GLI3 ALOX12B DNAL1 ZMYND10 UNG NRAS RFXAP IL2RB NKX2-1 RSPH9 PLOD1 SPINK5 SCNN1B GBA GAS8 CFAP298 CLCA4 GNPTAB LEP CLIP2 CCDC65 CD3G FCN3 CYBA SMN1 TRIP4 EP300 USB1 UBB DOCK8 LAMTOR2 TBC1D24 NECTIN1 SAMD9 SCNN1G CCNO CIITA MUC5B HLA-DPB1 DNAAF1 LCK ICOS NPM1 SPAG1 CCDC40 TRAIP CARD11 RSPH4A TBL2 ASAH1 PTPRC ALMS1 RUNX2 DNAAF4 NOTCH3 SH3KBP1 SNORD115-1 DNAI1 BACH2 RAG2 TSC1 TNFRSF13C IDUA IL2RG DNAAF6 GALNS IDUA SLC25A22 FUCA1 B2M SFTPC FLI1 CD3E MGP CD8A ELANE SULT2B1 TCF3 SLC29A3 RELB TPM2 CCDC103 ACTA1 HELLS FCGR2A LAMB2 SLC5A7 SPEF2 AGA SDR9C7 PYROXD1 CLEC7A HERC2 KRAS SMPD1 SOX11 CD247 MESP2 DDR2 GTF2I BLNK KIAA0586 BLNK FOXP1 SMARCA4 EDARADD SGCG MYSM1 ARID1A GNS CD79B MPLKIP LYST NPAP1 NCF1 CYP4F22 SRP54 TPP2 RNU4ATAC TRIP11 NGLY1 LRBA DNMT3B P4HTM SELENON STX1A TRPS1 COL13A1 TNFRSF13B DNAAF5 VPS13A CD81 INPPL1 CARMIL2 TAP1 NOTCH2 MESP2 GATA2 SNX10 CSF2RB SDCCAG8 JAK3 TBCE DOCK8 SHROOM4 RTEL1 OSTM1 CCDC151 LETM1 SMPD1 IL21 DNAJB13 JAK3 RNF125 INSR STK36 SCN10A IL7R MYH3 POLA1 CD19 CR2 ARID1B CD3D RSPH3 TAPBP CYBB DRC1 VAMP1 ADNP DCLRE1C PTPN22 NDN SGSH ARSB LRRC56 LRRC6 SP110 CCDC40 SLC25A1 ASAH1 PCGF2 BTK CCBE1 COL6A1 GATA6 PGM3 COG4 PSAP SLC46A1 SCN9A IKBKB CFB GAS2L2 TGFB1 PEPD SMARCC2 RNU4ATAC MYL2 SCN11A COL6A2 POLR3A GTF2E2 TSC2 WRAP53 ITGA3 CFI SCNN1B BTK CCDC22 DNAI2 CFTR ZAP70 DCTN4 CD79B RYR1 ADAMTS3 CD81 PLG SYT2 USP9X DKC1 KIF1A PRPS1 ELANE AFF4 ALB NME8 TNFRSF13C MAP3K20 TNFSF12 TIRAP STAT3 CCDC114 ADA SMARCE1 DSG1 PIK3R1 RPGR CREBBP HACD1 PRTN3 NFE2L2 DPM2 FLNA RMRP DNAH11 ERF EPM2A HYDIN G6PC3 ATM GAS8 SNORD116-1 DNAH11 NFKB2 EPG5 BCL10 DPF2 BAZ1B ERCC2 AK2 EHMT1 MS4A1 DNAAF3 CCDC151 LIG4 NFKB2 FBLN5 ZMYND10 ATP6V0A2 IL17RA TARS1 NXN COL6A3 TCIRG1 RFC2 WASHC5 WIPF1 GATA4 NOP10 RFXANK RSPH4A HLA-B SLC52A3 NME8 NHP2 CXCR4 GSN PCNT TNFRSF13B LEP IL17RC AGRN CORO1A CCDC65 RPGR NADK2 CD55 GTF2IRD1 IL17F ALG12 COL11A2 NHLRC1 ABCA12 LTBP3 SCNN1B ABCA12 NSD2 TECPR2 MANBA PARN GFI1 EPG5 NBN FLNA RNF113A CCDC39 PMM2 SCNN1A ICOS RFXANK TNFSF12 PWRN1 CARD11 SFTPC MGP USB1 OFD1 JAGN1 LRRC6 TYK2 IL21R FMO3 CFTR AGA PLP1 STAT1 NR2F2 CYBC1 SLC35A1 HLA-DPA1 RIPK1 DNAAF1 ORC6 RAG2 HPS6 CACNA1C GMNN IDUA RYR1 CFAP298 KIAA0556 TNFRSF13B AICDA KDM6A CLCN7 PANK2 SAMD9L RANBP2 ROR2 ELN CIITA TPM3 RSPH3 ADA DNAAF2 KMT2D ZNF341 GBA TNFRSF1A IL7R LEPR NAGLU RAG2 COG4 SCNN1A IGHM DLL3 TRAF3IP2 CSF2RA LAMTOR2 BLM NSMCE3 UMPS PGM3 RFX5 GRHL3 EGFR ELP1 PNP LIPN DNAH5 HGSNAT SETBP1 ECM1 TTC25 CR2 ADA MASP2 SFTPA2 AP3D1 MBTPS2 RAC1 TTC25 KAT6B ZAP70 IFIH1 ALPL IGHM SCNN1G DNAAF5 RAG2 NBN FAT4 SNRPN CD19 TGM1 ACADVL TNFSF11 CYBB PTPN22 PEX13 TK2 CACNA1B GAA PRKDC ARMC4 ALOXE3 CR2 CYBA RAG1 NCF1 SNAP25 CDCA7 IPW CXCR4 TERC RAG1 CD19 CD3E CD79A DNAH5 TFRC MCM4 FOXP3 IRF8 CFAP221 CTC1 LYST DNAI2 KCNJ6 EXOSC9 CD3D CRKL RYR1 CCDC114 PLG DCLRE1C SLC25A24 DCLRE1C LRRC8A ICOS TGFB1 CTLA4 XIAP IL7R IKBKG VPS33A FOXJ1 NELFA IL2RG CASP8 RAG1 CHAT IGLL1 CFAP410 CCNO ALMS1 NCF2 UNC119 GLB1 CHRM3 RSPH1 TNFRSF13C ERCC3 LIMK1 CTLA4 CD79A RAG1 SLC26A2 STAT1 DNAH1 RSPH9 CFTR NCF2 WAS MECP2 CCDC103 IL2RA SLC12A6 ACTA1 IKBKB ATM DNAAF3 LRRC56 RAB3GAP2 PIGN MAGEL2 IKZF1 PRKCD ACP5 CHAMP1 SLC35C1 MKRN3-AS1 HYDIN SH2D1A MTHFD1 SMARCB1 NCF4 RAG1 XIAP MAPK1 PIK3R1 TERT PWAR1 CHD7 IGH OCRL MS4A1 DNAAF6 PIK3R1 SMARCD2 CCDC39 TBX6 UBE2A STING1 NKX2-1 ELP1 OFD1 COL13A1 ARID2 ZBTB24 TINF2 MYO5A WDR19 GNPTAB COL11A2 NFIX RAG2 SCNN1A RFXAP PLCG2 USP9X NFKB1 NIPAL4 NCF4 ZNHIT3 MALT1 SCNN1G IL2RG BCR POLE TCIRG1 INPPL1 TBC1D23 GBA DNAJB13 GUSB PIK3CD ITGA7 CSPP1 SMN1 TERT DNMT3B NFKB2 MCIDAS DCLRE1C
Protein Mutations 1
H275Y
SNP 0