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D011665: Pulmonary Valve Insufficiency

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (21)


Name (Synonyms) Correlation
drug3126 Pemziviptadil (PB1046) Wiki 0.33
drug4134 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Wiki 0.33
drug4450 Tracheotomy Wiki 0.33
Name (Synonyms) Correlation
drug4136 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Wiki 0.33
drug3917 Senicapoc Wiki 0.33
drug4137 Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki 0.33
drug444 Awake Prone Positioning Wiki 0.33
drug2393 Low Dose (10 mg) Control Wiki 0.33
drug365 Aprepitant injectable emulsion Wiki 0.33
drug4135 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Wiki 0.33
drug4645 Ventil - a gas flow divider Wiki 0.33
drug4555 Ulinastatin Wiki 0.33
drug3704 Risankizumab Wiki 0.24
drug154 ATI-450 Wiki 0.24
drug319 Angiotensin-(1-7) Wiki 0.24
drug4334 Telmisartan Wiki 0.19
drug3847 Saline Placebo Wiki 0.19
drug4092 Standard care Wiki 0.11
drug1150 Convalescent plasma Wiki 0.07
drug3635 Remdesivir Wiki 0.06
drug3195 Placebo Wiki 0.05

Correlated MeSH Terms (15)


Name (Synonyms) Correlation
D000075902 Clinical Deterioration NIH 0.24
D011654 Pulmonary Edema NIH 0.19
D012128 Respiratory Distress Syndrome, Adult NIH 0.12
Name (Synonyms) Correlation
D012127 Respiratory Distress Syndrome, Newborn NIH 0.11
D013577 Syndrome NIH 0.09
D006333 Heart Failure NIH 0.08
D055371 Acute Lung Injury NIH 0.08
D000860 Hypoxia NIH 0.06
D008171 Lung Diseases, NIH 0.06
D007249 Inflammation NIH 0.06
D012141 Respiratory Tract Infections NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.04
D018352 Coronavirus Infections NIH 0.03
D011014 Pneumonia NIH 0.03
D007239 Infection NIH 0.02

Correlated HPO Terms (7)


Name (Synonyms) Correlation
HP:0010444 Pulmonary insufficiency HPO 1.00
HP:0100598 Pulmonary edema HPO 0.19
HP:0001635 Congestive heart failure HPO 0.08
Name (Synonyms) Correlation
HP:0012418 Hypoxemia HPO 0.06
HP:0002088 Abnormal lung morphology HPO 0.06
HP:0011947 Respiratory tract infection HPO 0.05
HP:0002090 Pneumonia HPO 0.03

Clinical Trials

Navigate: Correlations   HPO

There are 9 clinical trials


1 Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes. The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes. The objectives of this study are to: - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS) - Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals

NCT03225807
Conditions
  1. Acute Respiratory Distress Syndrome
  2. ARDS
  3. Respiratory Distress Syndrome, Acute
  4. Respiratory Insufficiency
  5. Respiratory Distress Syndrome
  6. Sho
  7. Shock Lung
  8. Severe Acute Respiratory Syndrome
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Valve Insufficiency Syndrome
HPO:Pulmonary insufficiency

Primary Outcomes

Measure: Ventilator free days to day 28

Time: 28 days

Secondary Outcomes

Measure: 30 day mortality

Time: 30 days

Measure: 90 day mortality

Time: 90 days

Measure: Hospital discharge disposition

Time: 30 days

Measure: Hospital mortality

Time: 1 week

Measure: Time to first ICU activity

Time: 24 hours
2 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
Conditions
  1. Acute Respiratory Tract Infection
  2. Acute Respiratory Insufficiency
  3. Pneumonia
  4. Septic Shock
  5. Hypoxemia
Interventions
  1. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.
  2. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection
  3. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation
  4. 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 10 days

Description: The number of days a patient is hospitalized

Measure: Duration of hospitalization

Time: up to 10 days

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: an average of 10 days
3 Assesment of Usefulness of Ventil Device for Mechanical Ventilation in ICU Patients

During Covid-19 pandemic many patients require mechanical ventilation due to disastrous impact of SARS-CoV-2 on lungs. In several countries there is a shortage of ICU beds and ventilators. Critically ill patients are treated outside ICUs. Doctors are facing ethical dilemmas who they should treat with ventilation, who should receive ventilator and who should but will not. In ICUs or step down units or in nursery homes there are also patients beyond hope treated - very often they are dependent on mechanical ventilation. Some attempts to invent a device that could replace complex machines in patients with anticipated poor outcome have been made. Ventil was used in clinical scenarios for separate lung ventilation with good effect. As a flow divider it has a potential to ventilate 2 patients at the same time. In the study Ventil will ventilate one patient and instead of the second there will be an artificial lung. Tidal volumes, minute ventilation, PEEP set and final will be checked. Ppeak, Pmean, Pplat, Cdyn, airway resistance, EtCO2, Sat O2, HR, SAP, DAP will be monitored every 2 hrs, as well as blood-gas analysis (every 8 hrs).

NCT04355754
Conditions
  1. Respiratory Insufficiency
Interventions
  1. Device: Ventil - a gas flow divider
MeSH:Respiratory Insufficiency Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: Ventil will be removed from the patient-ventilator circiuit in case of episodes of desaturation <90% (in pts without COPD) without reversibel reason; need for FiO2 increase by 10%; need for switch to other than CMV mode of ventillation need for neuromucular blockade or for deepen sedation because of assynchrony between patient and venilator cummulation of CO2>45 mm Hg (in pts without COPD) not responding to the increase of minute ventilation for 30 minutes; if Pplat >30 cmH2O; in case of new haemodynamic disturbances that cannot be explaned by other reasons; in case of increase or decrease of BP by 20%; increase or decrease of HR by 20%; in case of occurence of clinically important heart rhythm disturbances

Measure: Number of cases in which it was necessary to stop using Ventil and to step- back to ventilation without this flow divider

Time: 48 hours
4 Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19

Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.

NCT04395144
Conditions
  1. Coronavirus Infection
  2. COVID
  3. Severe Acute Respiratory Syndrome
  4. Respiratory Failure
  5. Respiratory Insufficiency
  6. Respiratory Distress Syndrome
  7. ARDS
  8. Lung Diseases
Interventions
  1. Procedure: Awake Prone Positioning
  2. Procedure: Standard care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Pulmonary Valve Insufficiency Syndrome
HPO:Abnormal lung morphology Pulmonary insufficiency

Primary Outcomes

Measure: Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death

Time: Up to 28 days after randomization

Secondary Outcomes

Measure: Intubation rate

Time: Up to 28 days after randomization

Measure: Mortality

Time: Up to 28 days after randomization

Measure: Days spent on mechanical ventilation

Time: Until discharge, up to 24 weeks after randomization

Measure: Days spent in the ICU

Time: Until discharge, up to 24 weeks after randomization

Measure: Hospital stay (in days)

Time: From admission to discharge, up to 24 weeks after randomization

Other Outcomes

Description: Total time spent in prone position, as recorded by nursing or respiratory therapists

Measure: Time in prone position

Time: Up to 28 days post randomization

Description: Daily evolution of oxygenation

Measure: Oxygenation (SpO2/FiO2 ratio)

Time: Until HFNC weaning, or up to 14 days after randomization, whichever is first
5 Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial

Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days) vs late (after at least 10 days) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality will be evaluated and compared.

NCT04412356
Conditions
  1. Covid-19
  2. ARDS
  3. Tracheostomy Complication
  4. Respiratory Insufficiency
  5. Corona Virus Infection
Interventions
  1. Procedure: Tracheotomy
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: Number of days without mechanical ventilation

Measure: Mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Number of days at ICU

Measure: ICU stay

Time: 28 days

Description: Number of days with need of additional oxygen support

Measure: Oxygen support

Time: 28 days

Description: Number of days with the need of sedation

Measure: Sedation

Time: 28 days

Description: Various adverse events associated with the tracheotomy/tracheostomy

Measure: Adverse events

Time: 28 days

Description: Mortality

Measure: Mortality

Time: 90 days
6 A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of Pemziviptadil (PB1046), a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)

This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.

NCT04433546
Conditions
  1. Acute Respiratory Distress Syndrome
  2. Coronavirus
  3. Hypoxic Respiratory Failure
  4. Hypoxemic Respiratory Failure
  5. Respiratory Complication
  6. Respiratory Insufficiency
  7. Cardiac Dysfunction
  8. Pneumonia
  9. Pulmonary Edema
  10. Pulmonary Inflammation
  11. Respiratory Failure
  12. Cytokine Storm
  13. COVID 19
  14. SARS-CoV-2
  15. Cardiac Event
  16. Cardiac Complication
  17. Cardiac Failure
  18. Cardiac Infarct
Interventions
  1. Drug: Pemziviptadil (PB1046)
  2. Drug: Low Dose (10 mg) Control
MeSH:Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Edema Pulmonary Valve Insufficiency Heart Failure Syndrome Inflammation Clinical Deterioration
HPO:Abnormal left ventricular function Congestive heart failure Pneumonia Pulmonary edema Pulmonary insufficiency Right ventricular failure

Primary Outcomes

Measure: Time to clinical recovery from initiation of pemziviptadil (PB1046)

Time: 28 days

Secondary Outcomes

Measure: Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge)

Time: 28 days

Measure: Time to hospital discharge

Time: Any time point between injection initiation and Day 28

Measure: All-cause mortality

Time: 28 days

Description: Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy

Measure: Reduction in hospital resource utilization defined as a composite of: total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy

Time: 28 days

Measure: Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first.

Time: Any time point between injection initiation and Day 28

Measure: Change from baseline in cardiac marker troponin I (TrI)

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in cardiac marker NT-proBNP/BNP

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in TNF alpha

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in IL-1

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in IL-6

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by clinical adverse events (AEs) and their relationship to pemziviptadil (PB1046).

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to pemziviptadil (PB1046)

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to pemziviptadil (PB1046)

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by electrocardiogram (ECG) abnormalities and their relationship to pemziviptadil (PB1046)

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by incidence of anti-drug antibodies and their relationship to pemziviptadil (PB1046)

Time: Any time point between injection initiation and Day 35+7

Other Outcomes

Measure: Impact on invasive hemodynamic parameters as measured by pulmonary artery pressure if patients require right-heart catherization

Time: Any time point between injection initiation and Day 35+7

Measure: Impact on invasive hemodynamic parameters as measured by cardiac output if patients require right-heart catherization

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence of multi-system organ failure (MSOF)

Time: Any time point between injection initiation and Day 35+7

Measure: Number of multi-system organ failure (MSOF) free days

Time: Any time point between injection initiation and Day 35+7

Measure: Number of subjects requiring extracorporeal membrane oxygenation (ECMO)

Time: Any time point between injection initiation and Day 35+7

Measure: Change in circulating ferritin

Time: Any time point between injection initiation and Day 35+7

Measure: Change in circulating D-dimer

Time: Any time point between injection initiation and Day 35+7

Measure: Change in liver function

Time: Any time point between injection initiation and Day 35+7

Measure: Change in other blood chemistry

Time: Any time point between injection initiation and Day 35+7

Measure: Change in hematology

Time: Any time point between injection initiation and Day 35+7

Measure: Change in inflammatory markers

Time: Any time point between injection initiation and Day 35+7

Measure: Change in coagulation markers

Time: Any time point between injection initiation and Day 35+7

Measure: Percent of clinical failure

Time: Any time point between injection initiation and Day 35+7
7 Effectiveness and Safety of Telmisartan in Acute Respiratory Failure Due to COVID-19

Rationale: The renin-angiotensin-aldosterone system (RAAS) dysregulation may play a central role in the pathophysiology of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection associated acute lung injury (ALI) / acute respiratory distress syndrome (ARDS). In the RAAS, Angiotensin I (Ang I) is converted to angiotensin II (Ang II) by angiotensin converting enzyme (ACE). Ang II mediates vasoconstrictive, pro-inflammatory and pro-oxidative effects through agonism at Ang II type 1 receptor (AT1R). ACE2 converts Ang II to angiotensin 1-7 (Ang1-7), which finally binds to Mas receptor (MasR) and mediates many beneficial actions, including vasodilation and anti-inflammatory, anti-oxidant and antiapoptotic effects. ACE2, a homologue of ACE, is an integral cell membrane protein with a catalytic domain on the extracellular surface exposed to vasoactive peptides. SARS-CoV-2 penetrates the cell through ACE2, and the increase of this receptor (due to the use of ACE inhibitors or angiotensin receptor blockers [ARBs]) may facilitate SARS-CoV-2 infection, which might increase the risk of developing severe and fatal SARS-CoV-2 infection. However, through upregulation of ACE2, ACE inhibitors/ARBs can exert anti-inflammatory and antioxidative effects, which may be beneficial in preventing ALI and ARDS. Objective: To evaluate the effectiveness and safety of telmisartan in respiratory failure due to COVID-19. Study design: This is an open label, phase 2 clinical trial. Study population: Adult hospitalized SARS-CoV-2-infected patients (n=60). Intervention: The active-treatment arm will receive telmisartan 40 mg daily and the control arm will receive standard care. Treatment duration will be 14 days or up to hospital discharge <14 days or occurrence of the primary endpoint if <14 days. Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) Mechanical ventilation or 2) Death.

NCT04510662
Conditions
  1. COVID-19
  2. Respiratory Insufficiency
  3. Telmisartan
  4. Respiratory Distress Syndrome, Adult
Interventions
  1. Drug: Telmisartan
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Acute Lung Injury Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: Death is defined as all-cause mortality

Measure: Death

Time: Within 30 days

Description: Occurrence of mechanical ventilation

Measure: Mechanical ventilation

Time: Within 14 days

Secondary Outcomes

Description: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2

Measure: Occurrence of acute kidney injury

Time: Within 14 days

Description: Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic

Measure: Incidence of hypotension

Time: Within 14 days

Description: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension

Measure: Incidence of hypotension requiring vasopressors

Time: Within 14 days

Description: Outcome reported as the number of participants in each arm who experience sepsis, defined as the presence of at least 2 of the following clinical criteria together (qSOFA score): respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less

Measure: Incidence of Sepsis

Time: Within 14 days

Description: Hospital length of stay (days)

Measure: Hospital length of stay

Time: Within 14 days
8 Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial

SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease that has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of April 1, 2020, there are 874.081 numbers of confirmed cases with 43.290 fatalities. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. Key markers implying a fatal outcome are acute respiratory distress syndrome (ARDS)-like disease with pronounced dyspnea, hypoxia and radiological changes in the lung. Senicapoc improves oxygenation and reduces fluid retention, inflammation, and bleeding in the lungs of mice with ARDS-like disease. In cells, there is an antiviral effect of senicapoc.

NCT04594668
Conditions
  1. ARDS, Human
  2. COVID
Interventions
  1. Drug: Senicapoc
MeSH:Respiratory Insufficiency Respiratory Distress Syndrome, Adult Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: The PaO2/FiO2 ratio will be calculated based on the arterial gas closest to the time-point of Day 3 after randomization

Measure: PaO2/FiO2 ratio

Time: Day 3

Secondary Outcomes

Description: Ventilator-free days will be defined as the number of days (or proportion of days) within the first 28 days after randomization where the patient is alive and not on invasive mechanical ventilation

Measure: Ventilator-free days

Time: Day 28

Description: Assessment of mortality is considered a core outcome for trials within acute respiratory failure

Measure: Mortality

Time: Day 28

Other Outcomes

Description: An infusion of a vasopressor will be defined as any continuous infusion of noradrenaline, dopamine, dobutamine, terlipressin, vasopressin, phenylephrine, and/or adrenaline

Measure: Vasopressor-free days

Time: Day 28

Description: The Sequential Organ Failure Assessment (SOFA)-score 1-4 will be used with 1 as best and 4 as worst score. The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. The sub scores as well as the overall SOFA score will be assessed. The calculation of the SOFA score will be based on available clinical and laboratory data. Laboratory and clinical data closest to the given time point will be used. If a given component (e.g. bilirubin) is not available, it will be assumed to be within normal ranges.

Measure: Sequential Organ Failure Assessment (SOFA)-score

Time: Day 1, 2, 3, and 5

Description: Renal replacement therapy includes dialysis (hemodialysis or peritoneal dialysis), hemofiltration, and hemodiafiltration.

Measure: Need for renal replacement therapy

Time: Day 28

Description: Health-related quality of life (EQ-5D-5L) in 5 dimensions and 5 levels (1-5) with 1 as worst and 5 as best level in each dimension. At day 28 EQ-5D-5L will be assessed via telephone communication with the patient or a surrogate. The telephone interview will be semi-structured and based on the EQ-5D-5L questionnaire. The interview will be conducted by a centrally-located and trained member of the research team according to detailed standard operating procedures. In case the patient is still in the hospital, this interview will be face-to-face.

Measure: Health-related quality of life (EQ-5D-5L)

Time: Day 28

Description: Quantification of viral load before and after treatment

Measure: Measurement of SARS-CoV2 load

Time: Day 0 and 3
9 Convalescent Plasma in the Treatment of Covid-19

One hundred patients hospitalized and in need of oxygen treatment due to Covid-19 should be randomized and 50% treated with 200 ml convalescent plasma x 3 and 50% given ordinary treatment. Primary outcome is number of days the patients need oxygen within 28 days from inclusion. Secondary outcome is number of days in hospital, number of days in respirator and mortality. Side effects of treatment is monitored.

NCT04600440
Conditions
  1. Covid-19
  2. Respiratory Insufficiency
Interventions
  1. Biological: Convalescent plasma
MeSH:Respiratory Insufficiency Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: Number of days in need of oxygen within 28 days from inclusion

Measure: Number of days in need of oxygen

Time: 28 days

Secondary Outcomes

Description: number of days before discharge from hospital

Measure: Number of days before discharge from hospital

Time: 3 months

Description: death of patient

Measure: Mortality within 3 months

Time: 3 months

Description: number of days before need of assisted ventilation

Measure: Number of days before need of assisted ventilation

Time: 28 days

HPO Nodes


Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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