CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D004630: Emergencies NIH

(Synonyms: Emergencies)

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


Correlated Drug Terms (14)


Name (Synonyms) Correlation
drug857 NIO® (Intraosseous access) Wiki 0.33
drug250 COVID-19 Pandemic Wiki 0.33
drug705 Intravenous access Wiki 0.33
drug1597 modified IPAC-UHN PPE Wiki 0.33
drug1281 Standard of Care (Intravenous access) Wiki 0.33
drug1274 Standard Plasma Wiki 0.33
drug1549 current IPAC-UHN PPE Wiki 0.33
drug703 Intraosseous access Wiki 0.33
drug1605 nasopharyngeal swab Wiki 0.33
drug1157 Retrospective data collection Wiki 0.33
drug1391 Throat swab and/or nasopharyngeal swab Wiki 0.33
drug403 Data collection Wiki 0.19
drug1104 Questionnaire Wiki 0.11
drug360 Convalescent Plasma Wiki 0.10

Correlated MeSH Terms (6)


Name (Synonyms) Correlation
D005157 Facial Pain NIH 0.33
D006323 Heart Arrest NIH 0.24
D007251 Influenza, Human NIH 0.13
D014777 Virus Diseases NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001695 Cardiac arrest HPO 0.24

There are 9 clinical trials

Clinical Trials


1 Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain

This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.

NCT01592799 Influenza Procedure: Throat swab and/or nasopharyngeal swab Other: Data collection
MeSH:Influenza, Human Emergencies

Primary Outcomes

Description: ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.

Measure: Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever

Time: Day 0 till Day 28-37

Description: Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.

Measure: Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza

Time: Day 0 till Day 28-37

Secondary Outcomes

Description: Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.

Measure: Number of Subjects With Other Laboratory-confirmed Respiratory Viruses

Time: Day 0 till Day 28-37

Description: Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.

Measure: Number of Subjects With Fatal Outcomes

Time: Day 0 till Day 28-37

Description: The outcome assessed the various complications by laboratory-confirmed influenza status.

Measure: Number of Subjects With Secondary Bacterial Infections

Time: Day 0 till Day 28-37

Description: Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.

Measure: Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: The outcomes was assessed in subjects with laboratory-confirmed influenza status

Measure: Number of Days of Hospitalization

Time: Day 0 till Day 28-37 (between October 2010 until May 2011)

Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Measure: Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit

Time: Day 0 till Day 28-37

Description: School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.

Measure: Number of Days of School Absenteeism

Time: Day 0 till Day 28-37

Description: This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.

Measure: Number of Days of Parent or Caregiver Time Off Work

Time: Day 0 till Day 28-37

Description: This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.

Measure: Number of Subjects With Household Members With Influenza-like Illness

Time: Day 0 till Day 28-37

Description: This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.

Measure: Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)

Time: Day 0 till Day 28-37

2 Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France

Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.

NCT04336761 Coronavirus COVID Infection Viral Diagnostic Test: nasopharyngeal swab
MeSH:Emergencies Virus Diseases

Primary Outcomes

Measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR

Time: At 28 days

Secondary Outcomes

Description: children admitted to pediatric emergencies for respiratory signs Children hospitalized as a result of travelling to pediatric emergency departments for respiratory signs Respiratory asymptomatic children admitted to pediatric emergencies

Measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients

Time: at the end an average 28 days

Measure: Respiratory signs of children tested within 28 day

Time: through study completion, an average 28 days

Measure: Percentage of children hospitalized tested within 28 day

Time: through study completion, an average 28 days

Description: the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency

Measure: Contact frequency

Time: At inclusion

Measure: Prevalence of positivity of other respiratory viruses measured by rt-PCR

Time: at 28 days

3 The Impact of the Coronavirus Disease 2019 (Covid-19) Outbreak on Emergency Room Attendances of Surgical Patients at a Tertiary Medical Center

Since December 2019, when the novel coronavirus disease (Covid-19) spread throughout the world, data have been needed on the effects of the pandemic on various aspects of healthcare systems. Recommendations for social distancing and quarantine decrees made by local governments, alongside the general public fear from the spread of the virus, are presumed to have markedly affected the trends in hospitals visits. Understanding the exact nature of the effect is critical for better anticipating and preparing health systems in the event of future outbreaks and in the post outbreak period. Therefore we intend to To identify retrospectively all patients who presented to the emergency department at our medical institute between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020. We will examine the impact of COVID-19 on the rates of surgical emergency visits, ratio of surgical visits to non-surgical visits, the ratio of severe presentations to non-severe presentations, and the impact of age on ED attendance.

NCT04338672 Emergency Service, Hospital General Surgery Other: COVID-19 Pandemic
MeSH:Emergencies

Primary Outcomes

Measure: Rates of emergency visits needing surgical consult

Time: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020

Measure: The ratio of severe presentations to non-severe presentations

Time: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020

Secondary Outcomes

Measure: The impact of age on ED attendance rates

Time: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020

Measure: Differences in ED surgical visits (in terms of capacity and severity) of surgical patients depending on the presentation and the co morbidity

Time: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020

4 Registry for Clinical Presentation and Management of Patients With COVID-19 in the Emergency Room

Patients with COVID-19 usually present in the ED and receive their initial medical check-up here. We will try to gather information of comorbidities and other conditions at the time of presentation of COVID-19 patients to the ED. The course of the disease prior to admission as well as the momentary health status at presentation to the ED are of interest because they influence risk stratification and decision-making of treating physicians. The ratio of patients with mild or moderate to severe symptoms will help to calculate the need for hospital beds including beds on Intensive Care Units (ICU) and Intermediate Care Units (IMC), as well as the need for other hospital resources.

NCT04351854 Corona Virus Infection SARS-CoV 2 Other: Retrospective data collection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Emergencies

Primary Outcomes

Description: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.

Measure: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.

Time: 6 months

Secondary Outcomes

Description: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED

Measure: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED

Time: 6 months

Description: Identification of the ratio of patients with mild or moderate to severe disease

Measure: Identification of the ratio of patients with mild or moderate to severe disease

Time: 6 months

5 Evaluation of the Management of Dental Emergencies During COVID 19 Crisis

"For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients. So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work. This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE). An additional study (URGDENT-NW) aiming at completing this study by focusing on patients consulting the emergency room at night and during the weekend is also in progress. The COVID19 Crisis changed the organization and the venue of patients at the emergency dental service. Therefore this project, based on the same protocol as URGENT and URGDENT-WE, aims at evaluating the Odontology Emergency Reception Service (SAUO) during the COVID 19 epidemy. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room ."

NCT04354272 Orofacial Pain Orofacial Edema Dental Trauma Oral Infection Other: Questionnaire
MeSH:Emergencies Facial Pain

Primary Outcomes

Description: "Self report measure of pain on the numeric scale 24h after the visit "

Measure: Pain score evolution measured by a 0-10 numeric scale (NS) where 0 is no pain and 10 the worst pain imaginable

Time: Day 1

Secondary Outcomes

Description: the pain is measured with the numeric scale

Measure: Pain scores evolution 3 days and 7 days after first visit measured by a numeric scale where 0 is no pain and 10 the worst pain imaginable

Time: Day 3 and Day 7

Description: Perception of welcoming, waiting time will be measured with a 0-10 numeric scale

Measure: welcoming quality from hospital staff

Time: Day 1

Description: The patient anxiety will be measured by numeric scale at Day 0, Day 1, Day 3, Day 7

Measure: anxiety score

Time: Day 0, Day 1, Day 3, Day 7

Description: The perception is measured just after care with a 0-10 numeric scale

Measure: perception of the technical quality of the emergency treatment

Time: Day 1

6 Convalescent Plasma to Limit Coronavirus Associated Complications: A Randomized Double-Blind, Phase 2 Study Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Placebo in Emergency Room Patients

This study will evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma (convalescent plasma) versus control (standard plasma) in patients with COVID-19 respiratory symptoms. This study will recruit patients who present for clinical evaluation in the emergency department (ED) but who do not require hospital admission. Disease progression due to COVID-19 will be assessed, which may include changes in symptom severity, return visit to the ED, or hospital admission.

NCT04355767 COVID-19 Biological: Convalescent Plasma Biological: Standard Plasma
MeSH:Emergencies

Primary Outcomes

Description: Progression of disease is defined as any of the following: Patient admitted to the hospital Patient seen in the emergency room (return visit after visit when enrollment takes place) Patient reports increased symptoms of 2 levels on the COVID Outpatient Ordinal Outcomes Scale over a 24 hour period Patient reports increased symptoms of 1 level on the COVID Outpatient Ordinal Outcomes Scale observed for a 48 hour period. COVID Outpatient Ordinal Outcomes Scale: Patient requires care in the hospital Patient requires care in the ED or urgent care Patient at home with symptoms rates as moderate (defined as fever, shortness of breath, abdominal pain) Patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness of breath) Patient in their usual state of health

Measure: Time to disease progression

Time: 15 days

Secondary Outcomes

Description: Categorical change in symptom severity rated on the COVID Outpatient Ordinal Outcomes Scale: Patient requires care in the hospital Patient requires care in the ED or urgent care Patient at home with symptoms rates as moderate (defined as fever, shortness of breath, abdominal pain) Patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness of breath) Patient in their usual state of health

Measure: Change in symptom severity over time

Time: 15 days

7 Intraosseous Versus Intravenous Access During COVID-19 Patients Performed by Paramedics Wearing Level C Personal Protective Equipment. A Multi-center Prospective Randomized Crossover Single-blinded Simulation Trial

The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.

NCT04366297 Cardiac Arrest Emergencies Device: Intravenous access Device: Intraosseous access
MeSH:Emergencies

Primary Outcomes

Description: successful placement of intravascular device

Measure: successful rate of first intravascular access attempt

Time: 1 day

Secondary Outcomes

Measure: time to successful access

Time: 1 day

Description: number of attempts to successful access

Measure: number of attempts to successful access

Time: 1 day

Description: time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics

Measure: time to infusion

Time: 1 day

Description: complication rates

Measure: complication rates

Time: 1 day

Description: self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy

Measure: ease of use

Time: 1 day

Description: participants were asked which method of intravascular access they would prefer in a real-life resuscitation.

Measure: Preferred intravascular access method

Time: 1 day

8 Comparison of Intraosseous Versus Intravenous Access in Suspected/Confirmed COVID-19 Patient in Prehospital Setting

The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.

NCT04366947 Emergency Medicine Cardiopulmonary Arrest Shock Device: NIO® (Intraosseous access) Device: Standard of Care (Intravenous access)
MeSH:Heart Arrest Emergencies
HPO:Cardiac arrest Cardiorespiratory arrest

Primary Outcomes

Description: successful placement of intravascular device

Measure: Success rate of first intravascular access attempt

Time: 1 day

Secondary Outcomes

Description: time to successful access

Measure: time to successful access

Time: 1 day

Description: number of attempts to successful access

Measure: number of attempts to successful access

Time: 1 day

Description: time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics

Measure: time to infusion

Time: 1 day

Description: complication rates

Measure: complication rates

Time: 1 day

Description: the rate of survival to hospital admission

Measure: ROSC

Time: 1 day

9 Accuracy of Routine Biomarkers and Blood Leucocytes Count to Assist Diagnosis of COVID-19-related Pneumonia in Adult Patients Visiting the Emergency Department

December 2019 was the onset of an outbreak of an infection related to SARS-CoV-2, a new coronavirus detected in January 2020 and responsible for a disorder termed COVID-19. Since then, COVID-19 has spread worldwide and is responsible for an unprecedented pandemic with major threat on global health and social and economic stability. Covid-19 has a large spectrum of symptoms. Most patients experience mild or moderate flu-like disorder with cough, fever, and shortness of breath. More severe presentations may occur; patients sometimes develop an acute pneumonia that can lead to adult respiratory distress syndrome. A considerable number of publications have been released for the last 10 weeks to help physicians making diagnosis and treat patients. Chinese authors have extensively proposed description of the disease. As signs and symptoms are poorly specific, diagnosis mostly relies on detection of the virus by RT-PCR in the upper respiratory tract. Some uncommon images and localization are highly specific and sensitive on chest CT-scan, which is cornerstone for initial diagnosis. However, resources may lack during healthcare crisis and results of these investigations may be delayed or unavailable developper. Special attention should also be paid to usual laboratory analysis. Indeed, decreased lymphocytes and eosinophilic counts are frequently described as well as increase in D-dimers levels. Variation of C-reactive protein (CRP) and procalcitonin (PCT) have been reported. Coronavirus may have cardiac tropism and changes in cardiac biomarkers concentration may occur. Therefore, some data suggest that values of routine biomarkers and blood cell count may assist physicians at bedside to support diagnosis of COVID-19. To face the outbreak, organization of emergency departments (ED) was mandatory to separate patients flows and avoid mixing patients with COVID-19 and others. Most patients visiting EDs dedicated to initial COVID-19 management suffered of pneumonia-like symptoms. Despite initial triage, patients had either COVID-19-related pneumonia either alternative diagnoses. We took advantage of this to evaluate the ability of routine biomarkers and leucocytes count helping identification of COVID-19 from alternative diagnoses.

NCT04401241 Covid19
MeSH:Emergencies

Primary Outcomes

Description: assess sensitivity of routine biomarkers and blood cell count for diagnosis of COVID-19-related pneumonia in low and high probability groups for level of certainty using the adjudication committee classification

Measure: routine biomarkers and blood cell count are discriminant to diagnose COVID-19

Time: 2 months

Secondary Outcomes

Description: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding CRP.

Measure: Probability of COVID-19 and CRP

Time: 2 months

Description: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding PCT.

Measure: Probability of COVID-19 and PCT

Time: 2 months

Description: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding Ddimers.

Measure: Probability of COVID-19 and Ddimers

Time: 2 months

Description: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding NTproBNP.

Measure: Probability of COVID-19 and NTproBNP

Time: 2 months

Description: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding cTnT-HS.

Measure: Probability of COVID-19 and cTnT-HS

Time: 2 months

Description: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding blood cell counts.

Measure: Probability of COVID-19 and blood cell counts

Time: 2 months

Description: Assess performance of combined routine biomarkers and blood cell count for diagnosis of COVID-19-related pneumonia independent parameters that will significantly differ in a univariate analysis will be combined. Their characteristics will be reported (Se, Sp, PPV, NPV, Likelihood ratios). The above mentioned assessment will be held at the exclusion of others

Measure: performance of combined routine biomarkers

Time: 2 months

Description: ii) to assess performance of combined routine biomarkers and blood cell count for diagnosis of COVID-19-associated pneumonia; assessment of characteritics for high probability and low probability patients : P value and AUC [95% CI] will be assessed comparing the 2 groups. iii) to assess whether usual biomarkers and blood cell count were associated with diagnosis of COVID-19-associated pneumonia using sensitivity analyses in predefinite subgroups chosen a priori; 1) when comparing definite versus excluded patients; 2) when comparing high vs. low probability patients, excluding bacterial infection (respiratory and extra-respiratory) in the low probability COVID-19-associated pneumonia group; 3) when comparing definite versus excluded probability patients, excluding bacterial infections (respiratory and extra-respiratory) in excluded patients. For each, P value and AUC [95% CI] will be assessed comparing the 2 groups

Measure: Assess usual biomarkers and blood cell count

Time: 2 months


HPO Nodes