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D000860: Hypoxia

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 (48)


Name (Synonyms) Correlation
drug1082 Double-Trunk Mask Wiki 0.26
drug1824 Lifelight® Data Collect Oxygen Saturation Group Wiki 0.18
drug2484 Pioglitazone Wiki 0.18
Name (Synonyms) Correlation
drug2651 Progressive cycling exercise test to exhaustion Wiki 0.18
drug3030 Self measurement with pulse oximeter Wiki 0.18
drug3126 Sodium Chloride 9mg/mL Wiki 0.18
drug3041 Self-prone position recommendation Wiki 0.18
drug3217 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Wiki 0.18
drug1561 Hyperbaric Oxygen Wiki 0.18
drug2355 Oxygen Hood Wiki 0.18
drug1277 FT516 Wiki 0.18
drug2203 Nitric Oxide-Continuous and Sessions Wiki 0.18
drug501 Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment Wiki 0.18
drug186 AirFLO2 Wiki 0.18
drug2205 Nitric Oxide-Sessions Wiki 0.18
drug2357 Oxygen gas Wiki 0.18
drug3109 Sirolimus 1 MG/ML Wiki 0.18
drug1121 ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY Wiki 0.18
drug1647 Individualized-Chinese herbal medicine Wiki 0.18
drug3215 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Wiki 0.18
drug796 Closed-loop control of oxygen supplementation by O2matic Wiki 0.18
drug2946 SARS-CoV2 infection Wiki 0.18
drug3218 Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki 0.18
drug1823 Lifelight® Data Collect Blood Pressure Group Wiki 0.18
drug3269 Surgical Mask Wiki 0.18
drug4115 thoracic CT-scan Wiki 0.18
drug1449 High Flow Nasal Oxygen (HFNO) treatment Wiki 0.18
drug337 Awake proning Wiki 0.18
drug3189 Standard interface Wiki 0.18
drug3598 VibroLUNG Wiki 0.18
drug1122 ELMO PROJECT AT COVID-19: STUDY IN HUMANS Wiki 0.18
drug3176 Standard Oxygen Delivery System Wiki 0.18
drug3216 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Wiki 0.18
drug863 Continuous Positive Airway Pressure (CPAP) therapy using OxyJet Wiki 0.18
drug1919 MK-5475 Wiki 0.18
drug1662 Inhaled nitric oxide (iNO) Wiki 0.18
drug2489 Pirfenidone Wiki 0.13
drug1076 Dornase Alfa Inhalation Solution [Pulmozyme] Wiki 0.13
drug1777 L-ascorbic acid Wiki 0.13
drug2206 Nitrogen gas Wiki 0.13
drug1751 Ivermectin Oral Product Wiki 0.13
drug1502 Hydrocortisone Wiki 0.11
drug3560 Usual care Wiki 0.11
drug2665 Prone positioning Wiki 0.09
drug1023 Dexamethasone Wiki 0.05
drug2215 No intervention Wiki 0.04
drug3199 Standard of care Wiki 0.03
drug2490 Placebo Wiki 0.02

Correlated MeSH Terms (13)


Name (Synonyms) Correlation
D059246 Tachypnea NIH 0.18
D012770 Shock, Cardiogenic NIH 0.18
D007022 Hypotension NIH 0.18
Name (Synonyms) Correlation
D012769 Shock, NIH 0.07
D011665 Pulmonary Valve Insufficiency NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04
D012141 Respiratory Tract Infections NIH 0.03
D011014 Pneumonia NIH 0.03
D012128 Respiratory Distress Syndrome, Adult NIH 0.03
D011024 Pneumonia, Viral NIH 0.02
D012127 Respiratory Distress Syndrome, Newborn NIH 0.02
D007239 Infection NIH 0.01

Correlated HPO Terms (7)


Name (Synonyms) Correlation
HP:0012418 Hypoxemia HPO 0.97
HP:0030149 Cardiogenic shock HPO 0.18
HP:0002615 Hypotension HPO 0.18
Name (Synonyms) Correlation
HP:0002789 Tachypnea HPO 0.18
HP:0010444 Pulmonary insufficiency HPO 0.07
HP:0011947 Respiratory tract infection HPO 0.03
HP:0002090 Pneumonia HPO 0.03

Clinical Trials

Navigate: Correlations   HPO

There are 30 clinical trials


1 Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.

NCT04344106
Conditions
  1. Coronavirus Infection
  2. Oxygen Deficiency
Interventions
  1. Procedure: Prone positioning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.

Measure: Proportion of "responder" patients to prone position

Time: 1 hour

Secondary Outcomes

Description: PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position.

Measure: proportion of "persistent responders" patients after prone position

Time: 1 day

Description: PaO2 at 1 hour from the start of prone position and at 6 to 12 hours afterreturn to supine position.

Measure: Evolution of PaO2

Time: 1 day

Description: Look for an association between the time spent in Prone positione and persistent responder or not;

Measure: Duration of prone positioning and PaO2 evolution

Time: 2 days

Description: proportion of patients improving their arterial saturation within 1 hour of Prone Position

Measure: Evolution of Spo2

Time: 1 hour

Description: evolution of the EVA scores for dyspnea at 1 hour from the start of the Prone Position and at 6 hours after the end of the Prone Position

Measure: EVA Dyspnea

Time: 1 day

Description: proportion of patients intolerant to prone position (Prone Position <1h);

Measure: Intolerance to prone positioning

Time: 1 day

Description: proportion of patients who can maintain prone position for more than 3 h.

Measure: Tolerance to prone positioning

Time: 1 day
2 Awake Prone Position for Early Hypoxemia in COVID-19

Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission. The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.

NCT04344587
Conditions
  1. COVID-19
Interventions
  1. Other: Self-prone position recommendation
  2. Other: Usual care
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Change in respiratory status will be defined as:1) admission to the ICU and/or a 2) an increase in supplemental oxygen delivery (defined as an increase in oxygen delivery rate of ≥2 liter per minute compared to the oxygen delivery rate at the time of intervention or usual care text message that is sustained for ≥12 or more hours OR the switch to an oxygen delivery method that increases the level of supplemental oxygen.

Measure: Change in respiratory status

Time: up to 30 days

Secondary Outcomes

Description: Length of time in the prone position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

Measure: Length of time participant spends in the prone position

Time: up to 30 days

Description: Length of time in the supine/lying on back position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

Measure: Length of time participant spends in the supine position

Time: up to 30 days

Description: Length of time lying on side will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

Measure: Length of time participant spends lying on side

Time: up to 30 days

Description: Length of time sitting up will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

Measure: Length of time participant spends sitting up

Time: up to 30 days

Description: Length of time standing or walking will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

Measure: Length of time participant spends standing or walking

Time: up to 30 days

Description: Dyspnea will be assessed by the modified Borg Dyspnea Score (10-point ordinal scale) from 1= nothing at all to 10= maximal. Higher scores indicate more dyspnea.

Measure: Dyspnea or difficult/labored breathing

Time: up to 30 days

Description: Discomfort with proning (4-point ordinal scale: very comfortable, somewhat comfortable, somewhat uncomfortable, very uncomfortable)

Measure: Discomfort with proning

Time: up to 30 days

Description: Total number of days hospitalized will be abstracted from the electronic medical record.

Measure: Length of hospital stay

Time: up to 30 days

Description: Invasive mechanical ventilation will be abstracted from the electronic medical record.

Measure: Invasive mechanical ventilation

Time: up to 30 days

Description: Loss of IV access as a consequence of turning in bed will be reported by participant using monitoring surveys

Measure: Loss of IV access as a consequence of turning in bed

Time: up to 30 days

Description: ARDS diagnosis will be abstracted from the electronic medical record

Measure: Acute respiratory distress syndrome (ARDS) diagnosis

Time: up to 30 days

Description: Hospital mortality will be abstracted from the electronic medical record

Measure: Hospital mortality

Time: up to 30 days
3 Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19

This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.

NCT04346420
Conditions
  1. COVID
  2. Hypoxemia
Interventions
  1. Other: Standard interface
  2. Device: Double-Trunk Mask
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: The O2 output will be adjusted to maintain a SpO2 of 94% using both systems for administering O2. The O2 flow will be read from the position of the ball in flow meters.

Measure: Change in O2 output

Time: At baseline and 30 minutes after wearing both systems

Secondary Outcomes

Description: A Likert scale from 0 to 5 will be used to measure the subjective comfort of the patient while wearing the standard interface for administering O2 and/or the DTM

Measure: Comfort with the interfaces

Time: 30 minutes after wearing both systems

Description: Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system

Measure: Changes in PaO2

Time: At baseline and 30 minutes after wearing DTM

Description: Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.

Measure: Changes in PaCO2

Time: At baseline and 30 minutes after wearing DTM

Description: Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.

Measure: Changes in pH

Time: At baseline and 30 minutes after wearing DTM

Description: Respiratory rate is measured during one minute by visual inspection.

Measure: Changes in respiratory rate

Time: At baseline and 30 minutes after wearing both systems
4 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
5 Low-dose Hydrocortisone in Patients With COVID-19 and Severe Hypoxia - the COVID STEROID Trial

We aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19 and severe hypoxia.

NCT04348305
Conditions
  1. Covid-19
  2. Hypoxia
Interventions
  1. Drug: Hydrocortisone
  2. Drug: Sodium Chloride 9mg/mL
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28

Measure: Days alive without life support at day 28

Time: Day 28 after randomisation

Secondary Outcomes

Description: Death from all causes

Measure: All-cause mortality at day 28

Time: Day 28 after randomisation

Description: Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 90

Measure: Days alive without life support at day 90

Time: Day 90 after randomisation

Description: Death from all causes

Measure: All-cause mortality at day 90

Time: Day 90 after randomisation

Description: Defined as new episodes of septic shock, invasive fungal infection, clinically important GI bleeding or anaphylactic reaction

Measure: Number of participants with one or more serious adverse reactions

Time: Day 14 after randomisation

Description: Number of days alive and out of hospital not limited to the index admission

Measure: Days alive and out of hospital at day 90

Time: Day 90 after randomisation

Description: Death from all causes

Measure: All-cause mortality at 1 year after randomisation

Time: 1 year after randomisation

Description: Assessed by EQ-5D-5L

Measure: Health-related quality of life at 1 year

Time: 1 year after randomisation

Description: Assessed by EQ-VAS

Measure: Health-related quality of life at 1 year

Time: 1 year after randomisation
6 Administration of Intravenous Vitamin C in Novel Coronavirus Infection and Decreased Oxygenation (AVoCaDO): A Phase I/II Safety, Tolerability, and Efficacy Clinical Trial

Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS. We hypothesize that HDIVC is safe and tolerable in Coronavirus disease 2019 (COVID-19) subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.

NCT04357782
Conditions
  1. COVID-19
  2. Hypoxia
Interventions
  1. Drug: L-ascorbic acid
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Occurrence of adverse events during study drug infusion

Measure: Incidence of adverse events

Time: Days 1-4

Description: Occurrence of serious adverse events during study drug infusion

Measure: Incidence of serious adverse reactions

Time: Days 1-4

Description: Occurrence of adverse reactions during study drug infusion

Measure: Incidence of adverse reactions

Time: Days 1-4

Secondary Outcomes

Description: Documented days free off mechanical ventilation the first 28 days post enrollment

Measure: Ventilator-free days

Time: Days 1-28

Description: Documented days free of ICU admission the first 28 days post enrollment

Measure: ICU-free days

Time: Days 1-28

Description: Documented days free of hospital admission the first 28 days post enrollment

Measure: Hospital-free days

Time: Days 1-28

Description: Incidence of mortality at 28 days by all causes

Measure: All-cause mortality

Time: Days 1-28

Description: SpO2 (% peripheral oxygenation saturation) will be divided by fraction of inspired oxygen (FiO2) at start of study infusion and compared with S/F ratio at end of study infusion

Measure: Change in S/F ratio during HDIVC infusion

Time: Days 1-4

Description: The difference in serum CRP during HDIVC infusion reported in mg/dL

Measure: C-reactive protein (CRP)

Time: Days 1-4

Description: The difference in LDH during HDIVC infusion will be reported in IU/L

Measure: Lactate dehydrogenase (LDH)

Time: Days 1-4

Description: The difference in D-dimer during HDIVC infusion will be reported in ug/mL

Measure: D-dimer

Time: Days 1-4

Description: The difference in lymphocyte count during HDIVC infusion will be reported in 10e3/uL

Measure: Lymphocyte count

Time: Days 1-4

Description: The NLR will be calculated by dividing the absolute neutrophil count (10e3/uL) over the absolute lymphocyte count (10e3/uL) and ratio compared with Day 1 versus Day 4

Measure: Neutrophil to Lymphocyte ratio (NLR)

Time: Days 1-4

Description: The difference in serum ferritin will be calculated from the start of HDIVC infusion to day 4 and reported as ng/mL

Measure: Serum Ferritin

Time: Days 1-4
7 A Single-site, Randomised, Controlled, Parallel Design, Open-label Investigation of an Approved Nebulised Recombinant Human DNase Enzyme (Dornase Alfa) to Reduce Hyperinflammation in Hospitalised Participants With COVID-19

An open-label, randomised, Best-Available-Care (BAC) and historic-controlled trial of nebulised dornase alfa [2.5 mg BID] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure (the COVASE study). Controls will include a randomised arm to receive BAC, historic data from UCLH patients with COVID-19 and biobanked samples will be used to demonstrate an effect of dornase alfa. CRP will be measured to assess the effect of dornase alfa on inflammation. Clinical endpoints and biomarkers (e.g. d-dimer) will be used to assess the clinical response. Exploratory endpoints will explore the effects of dornase alfa on features of neutrophil extracellular traps (NETs).

NCT04359654
Conditions
  1. COVID19
  2. Hypoxia
Interventions
  1. Drug: Dornase Alfa Inhalation Solution [Pulmozyme]
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Analysing stabilisation of C-reactive protein

Measure: Measuring the change in inflammation

Time: 7 days

Secondary Outcomes

Description: How many patients that are still alive

Measure: Number of patients that are alive at 28 days

Time: 28 days

Description: How many days on oxygen

Measure: Amount of days that patient requires oxygen

Time: 7 days

Description: Calculating index with Fi02, mean airways pressure and Pa02 via https://www.mdcalc.com/oxygenation-index#use-cases

Measure: Average oxygenation index

Time: 7 days

Description: How many days as an inpatient

Measure: Days patient admitted to hospital

Time: 7 days

Description: How many patients require mechanical ventilation

Measure: Percentage of patients that need mechanical ventilation

Time: 7 days
8 Study of FT516 Safety and Feasibility for the Treatment of Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients With Hypoxia

This is a Phase I study with the primary objective of identifying the maximum tolerated dose (MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the treatment of coronavirus disease 2019 (COVID-19). This study provides initial estimates of safety and efficacy based on stable respiratory function, as well as, determining the feasibility for full-scale studies designed both for efficacy and safety.

NCT04363346
Conditions
  1. COVID-19
Interventions
  1. Drug: FT516
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: An accelerated (fast-track) design will continue until first DLT is observed or the maximum Tolerated Dose (MTD) is determined. DLT is defined as any treatment emergent toxicity within 7 days after the last dose of FT516 meeting one of the following criteria based on CTCAE v5: Grade 3 or greater infusion related reaction following FT516 infusion Any new or worsening Grade 3 and any Grade 4 adverse events with the exception of the following known complications of COVID-19: Grade 3 gastrointestinal disorders (diarrhea) Grade 3 hepatic investigations (ALT increased, AST increased) Grade 3 leukopenia/lymphopenia Respiratory deterioration between the 1st dose and 7 days after the last dose of FT516 defined as the need for any type of assisted ventilation (invasive or non-invasive including BiPAP) or oxygen delivery device intended to deliver ≥60% FiO2 (including non-rebreather mask or >10L by simple facemask) to maintain an SpO2 >88%.

Measure: Number of participants with Dose Limiting Toxicity Events

Time: within 7 days after the last dose of FT516

Secondary Outcomes

Measure: The time in days from the 1st FT516 infusion to the elimination of viral shedding in nasal pharyngeal and stool samples

Time: 36 days

Measure: The time in days from the 1st FT516 infusion to discontinued need for supplemental oxygen

Time: 36 Days

Measure: The time in days from the 1st FT516 infusion to hospital discharge

Time: 36 Days
9 European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO

In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally. In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively. Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%. The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality. Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project. The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.

NCT04366921
Conditions
  1. COVID
  2. SARS-CoV-2
  3. ARDS, Human
  4. Refractory Hypoxemia
  5. Cardiogenic Shock
  6. Septic Shock
  7. Extracorporeal Membrane Oxygenation
MeSH:Respiratory Distress Syndrome, Adult Shock, Cardiogenic Shock Hypoxia
HPO:Cardiogenic shock Hypoxemia

Primary Outcomes

Description: age in years

Measure: Age

Time: at baseline

Description: male/female

Measure: Gender

Time: at baseline

Description: in kilograms

Measure: Weight

Time: at baseline

Description: in meters

Measure: Height

Time: at baseline

Description: weight and height combined to calculate BMI in kg/m^2

Measure: BMI

Time: at baseline

Description: Asthma y/n, cystic fibrosis y/n, chronic obstructive pulmonary disease y/n, pulmonary hypertension y/n, pulmonary fibrosis y/n, chronic restrictive lung disease y/n

Measure: Pre-existing pulmonary disease y/n

Time: at baseline

Description: diabetes mellitus y/n, chronic renal failure y/n, ischemic heart disease y/n, heart failure y/n, chronic liver failure y/n, neurological impairment y/n

Measure: Main co-morbidities y/n

Time: at baseline

Description: in dd-mm-yyyy or mm-dd-yyyy

Measure: Date of signs of COVID-19 infection

Time: at baseline or date of occurence

Description: in dd-mm-yyyy or mm-dd-yyyy

Measure: Date of positive swab

Time: at baseline or date of occurence

Description: in days

Measure: Pre-ECMO length of hospital stay

Time: at or during ECMO-implant

Description: in days

Measure: Pre-ECMO length of ICU stay

Time: at or during ECMO-implant

Description: in days

Measure: Pre-ECMO length of mechanical ventilation days

Time: at or during ECMO-implant

Description: y/n, what kind

Measure: Use of antibiotics

Time: up to 6 months

Description: y/n, what kind

Measure: Use of anti-viral treatment

Time: up to 6 months

Description: y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)

Measure: Use of second line treatment

Time: up to 6 months

Description: respiratory or cardiac

Measure: Indications for ECMO-implant

Time: at ECMO-implant

Description: veno-venous, veno-arterial or veno-venoarterial

Measure: Type of ECMO-implant

Time: at ECMO-implant

Description: peripheral or central

Measure: Type of access

Time: at ECMO-implant

Description: in dd-mm-yyyy or mm-dd-yyyy

Measure: Date of ECMO implant

Time: at ECMO-implant

Description: l/min

Measure: ECMO blood flow rate

Time: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

Description: l/min

Measure: ECMO gas flow rate

Time: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

Description: y/n

Measure: ECMO configuration change

Time: up to 6 months

Description: in dd-mm-yyyy or mm-dd-yyyy

Measure: Date of ECMO configuration change

Time: up to 6 months

Description: veno-venous, veno-arterial, veno-venoarterial, other

Measure: New ECMO configuration

Time: up to 6 months

Description: right ventricular failure, left ventricular failure, refractory hypoxemia

Measure: Indications for ECMO configuration change

Time: up to 6 months

Description: settings of ventilator

Measure: Ventilator setting on ECMO

Time: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

Description: heparin, bivalirudin, nothing

Measure: Anticoagulation during ECMO

Time: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

Description: amount of ECMO circuit changes (1, 2, 3 etc.)

Measure: Frequency of ECMO circuit change

Time: up to 6 months

Description: Hemorrhagic, infection, other complications

Measure: ECMO complications

Time: up to 6 months

Description: y/n

Measure: ECMO Weaning

Time: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

Description: y/n, date

Measure: ICU discharge

Time: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months

Measure: Main cause of death

Time: 6 months

Description: Ward, another ICU, rehabilitation center, home

Measure: Type of discharge

Time: up to 6 months

Measure: Alive/deceased

Time: 6 months
10 Main Features and Ventilatory Management of Patients With ARDS Caused by COVID-19

Patients with the acute respiratory distress syndrome (ARDS) have markedly varied clinical presentations. Main characteristics of mechanically ventilated ARDS caused by COVID-19, and adherence to lung-protective ventilation strategies are not well known.

NCT04368975
Conditions
  1. Acute Respiratory Failure With Hypoxia
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Measure: Discontinuation from mechanical ventilation

Time: 28 days
11 Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen

This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.

NCT04398290
Conditions
  1. COVID-19
  2. Hypoxemia
  3. Hypoxemic Respiratory Failure
Interventions
  1. Drug: Inhaled nitric oxide (iNO)
  2. Drug: Nitrogen gas
  3. Drug: Oxygen gas
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: As assessed per treating physician's discretion.

Measure: Incidence of treatment emergent adverse events

Time: Up to 14 days

Description: Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.

Measure: Incidence of adverse events

Time: Up to 6 hours

Description: Incidence of increase to > 5% total methemoglobin as assessed by pulse oximetry.

Measure: Incidence of methemoglobinemia

Time: Up to 14 days

Secondary Outcomes

Description: Worsening respiratory status as defined by any one of the following: Implementation of High Flow Nasal Cannula (HFNC), non-rebreather mask, non-invasive ventilation, intubation and mechanical ventilation or need for intubation (in the event the patient is not intubated due to do not intubate (DNI) or do not resuscitate (DNR) status).

Measure: Number of participants with progression of respiratory failure

Time: Up to 14 days

Description: The number of days until hypoxemia is resolved as per treating physician assessment

Measure: Time until resolution of hypoxemia

Time: Up to 14 days

Description: Incidence of death during hospitalization and after discharge up to 28 days

Measure: Incidence of mortality

Time: Up to 28 days

Description: Number of days of hospitalization

Measure: Duration of hospitalization

Time: Up to 28 days
12 The Use of Oxygen Hoods as Compared to Conventional High-flow Oxygen Delivery Systems, the Effects on Oxygenation, Mechanical Ventilation and Mortality Rates in Hypoxic Patients With COVID-19. A Prospective Controlled Cohort Study.

To determine whether the use of oxygen hoods as compared to conventional high-flow oxygen delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates in hypoxic patients with COVID-19.

NCT04407260
Conditions
  1. COVID -19
  2. Respiratory Failure
  3. Hypoxia
Interventions
  1. Device: Oxygen Hood
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Continuous pulse oximetry monitoring

Measure: Oxygen saturation

Time: 3/6/2020 - 5/1/2020

Description: Intubation/mechanical Ventilation at any point during hospitalization.

Measure: In-hospital Intubation/Mechanical Ventilation Status

Time: 3/6/2020 - 5/1/2020

Description: In-hospital Mortality status

Measure: In-hospital Mortality

Time: 3/6/2020 - 5/1/2020

Description: Duration of hospitalization

Measure: Length of Hospitalization

Time: 3/6/2020 - 5/1/2020
13 Awake Proning in Patients With COVID-19-Induced Acute Hypoxemic Respiratory Failure

The purpose of this study is to retrospectively review clinical data to determine whether awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe hypoxemic respiratory failure.

NCT04408222
Conditions
  1. Oxygen Deficiency
  2. Coronavirus Infection
Interventions
  1. Other: Awake proning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: SpO2 was measured by peripheral pulse oximetry.

Measure: Change in SpO2

Time: Before proning and 1 hour after initiation of the prone position

Secondary Outcomes

Description: The mean risk difference in intubation rates for patients with SpO2 ≥95% vs. <95% 1 hour after initiation of the prone position was assessed.

Measure: Mean Risk Difference in Intubation Rates

Time: Duration of hospitalization or up to 1 month from admission
14 A Study to Assess the Safety, Tolerability, and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia

The purpose of this study is to evaluate safety, tolerability, and pharmacodynamics of MK-5475 after administration of multiple doses to participants with COVID-19 pneumonia. The primary hypothesis is that MK-5475 when administered to participants with COVID-19 pneumonia and hypoxemia improves arterial oxygenation as measured by the ratio of blood oxygen saturation to fraction of inspired oxygen (SpO2/FiO2 ratio) compared to placebo.

NCT04425733
Conditions
  1. Coronavirus Disease 2019 (COVID-19)
  2. Pneumonia
  3. Hypoxemia
Interventions
  1. Drug: MK-5475
  2. Drug: Placebo
MeSH:Pneumonia Hypoxia
HPO:Hypoxemia Pneumonia

Primary Outcomes

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

Measure: Number of Participants Who Experience an Adverse Event (AE)

Time: Up to ~Day 21

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study drug due to an AE will be reported.

Measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)

Time: Up to ~Day 7

Description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours post-dose on Day 1 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 1 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 1.

Measure: Change From Baseline to Day 1 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)

Time: Baseline, Day 1 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)

Description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 2 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 2 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 2.

Measure: Change From Baseline to Day 2 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)

Time: Baseline, Day 2 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)

Description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 3 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 3 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 3.

Measure: Change From Baseline to Day 3 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)

Time: Baseline, Day 3 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)

Description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 4 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 4 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 4.

Measure: Change From Baseline to Day 4 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)

Time: Baseline, Day 4 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)

Description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 5 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 5 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 5.

Measure: Change From Baseline to Day 5 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)

Time: Baseline, Day 5 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)

Description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 6 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 6 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 6.

Measure: Change From Baseline to Day 6 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)

Time: Baseline, Day 6 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)

Description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 7 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 7 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 7.

Measure: Change From Baseline to Day 7 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)

Time: Baseline, Day 7 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)
15 Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure

NCT04435353
Conditions
  1. Respiratory Distress Syndrome
  2. Hypoxemia
Interventions
  1. Device: VibroLUNG
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Regression of respiratory failure under the influence of vibroacoustic therapy

Measure: Recovery respiratory fail

Time: 5-7 days
16 Elmo Respiratory Support Project for Patients With Hypoxemic Respiratory Insufficiency in Covid-19: Proof Of Concept and Usability

The number of COVID-19 cases has been growing exponentially, so that the industrialized economies are facing a significant shortage in the number of ventilators available to meet the demands imposed by the disease. Noninvasive ventilatory support can be valuable for certain patients, avoiding tracheal intubation and its complications. However, non-invasive techniques have a high potential to generate aerosols during their implementation, especially when masks are used in which it is virtually impossible to completely prevent air leakage and the dispersion of aerosols with viral particles. In this context, a helmet-like interface system with complete sealing and respiratory isolation of the patient's head can allow the application of ventilatory support without intubation and with safety and comfort for healthcare professionals and patients. This type of device is not accessible in Brazil, nor is it available for immediate import, requiring the development of a national product. Meanwhile, a task force under the coordination of the School of Public Health (ESP) and Fundação Cearense de Apoio à Pesquisa (FUNCAP), with support from SENAI / FIEC and the Federal Universities of Ceará (UFC) and the University of Fortaleza (UNIFOR) advanced in the development of a prototype and accessory system capable of providing airway pressurization through a helmet-type interface, which was called the Elmo System.

NCT04470258
Conditions
  1. COVID-19
  2. Respiratory Failure With Hypoxia
Interventions
  1. Other: ELMO PROJECT AT COVID-19: STUDY IN HUMANS
  2. Device: ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Usability test with the description of the identified problems of the main basic skills necessary for the correct handling of the non-invasive respiratory device (ELMO), through realistic simulations, severity scale and usability.

Measure: Usability tests of the Elmo system using Euristic usability principles

Time: One week after all tests

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through peripheral oxygen saturation (%) before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests

Secondary Outcomes

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through respiratory rate (irpm) before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through heart rate before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through blood pressure before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests

Description: To evaluate the effectiveness of the Elmo system in the supportive treatment of patients with hypoxemic respiratory failure caused by COVID-19 through CO2 measurement at the end of exhalation (mmHg) before, during and after the application of Elmo.

Measure: Evaluation of the effectiveness of the ELMO system using physiological parameters

Time: One week after all tests
17 GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study

Pioglitazone is an approved anti-hyperglycemic medication and is thought to have anti-inflammatory properties. This study seeks to gather safety and tolerability data related to pioglitazone when given to patients who require hospital admission for confirmed positive COVID-19 infections with elevated blood sugar levels as compared to patients who did not receive pioglitazone during their hospitalization for COVID-19.

NCT04473274
Conditions
  1. Coronavirus Infection
  2. Diabetes
Interventions
  1. Drug: Pioglitazone
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Number and type of adverse events

Measure: Adverse events outcomes without attribution

Time: Baseline, until 30 days after last dose

Description: Number and type of adverse events

Measure: Adverse events attributable

Time: Baseline, until 30 days after last dose

Secondary Outcomes

Description: Disease severity as measured by 7 point ordinal scale

Measure: Clinical improvement

Time: Baseline, until 30 days after last dose

Description: Type of oxygen support treatment

Measure: Levels of treatment

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of d-Dimer

Measure: d-Dimer

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of CRP

Measure: C Reactive Protein

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of Ferritin

Measure: Ferritin

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of Lactate dehydrogenase

Measure: Lactate dehydrogenase

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of A1c

Measure: A1c

Time: Baseline, until 30 days after last dose
18 A Safety Study on the Use of Intermittent Versus Continuous Inhalation of NO in Spontaneous Breathing COVID-19 Patients

Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).

NCT04476992
Conditions
  1. Hypoxemia
  2. Pneumonia, Viral
  3. Coronavirus Infection
Interventions
  1. Drug: Nitric Oxide-Sessions
  2. Drug: Nitric Oxide-Continuous and Sessions
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Hypoxia
HPO:Hypoxemia Pneumonia

Primary Outcomes

Description: The primary outcome will be evaluated with the difference in Methemoglobin levels between the groups at 48 hours after randomization.

Measure: Change in Methemoglobin level at 48 hours

Time: 48 hours

Secondary Outcomes

Description: The primary outcome will be evaluated with the difference in Methemoglobineamia between the groups at 96 hours after randomization.

Measure: Change in Methemoglobin level at 96 hours

Time: 96 hours

Description: The secondary outcome, "Improve the oxygenation at 48 hours," will be evaluated with the measure of the difference in oxygenation among the groups at 48 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.

Measure: Improvement in oxygenation between the groups at 48 hours or at discharge if before 48 hours

Time: 48 hours

Description: The secondary outcome, "Improve the oxygenation at 96 hours," will be evaluated with the measure of the difference in oxygenation between the groups at 96 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.

Measure: Improvement in oxygenation between the groups at 96 hours or at discharge if before 96 hours

Time: 96 hours

Description: The secondary outcome "difference in the rate of negative RT-PCR for SARS CoV-2" will be evaluated as the rate of negativization of the RT-PCR for SARS-CoV-2 at 5 days after randomization, at discharge and at 28 days after randomization.

Measure: Rate of positive RT-PCR for SARS-CoV-2 between groups in 5 days, discharge, and 28 days

Time: 28 days

Description: The secondary outcome "different time to clinical recovery" will be evaluated as the time between the randomization and the clinical indication to interrupt the administration of oxygen for 24 hours.

Measure: Time to clinical recovery among groups, defined as time to interruption of oxygen administration for 24 hours or discharge

Time: 28 days

Description: The secondary outcome "Different reduction in inflammatory markers" will be evaluated as improvement in the inflammatory markers (IL-6; Ferritin; White Blood Cells; Leucocyte count; CRP; D-Dimer) observed in blood samples collected at day 1, 2, 3, 4, and 7 compared to the Baseline value.

Measure: Reduction in the inflammatory markers among groups

Time: 7 days

Description: The secondary outcome "rate of AKI between groups" will be evaluated as the presence of a comparable rate of AKI during the hospital stay. The AKI will be defined according to the KDIGO classification.

Measure: Rate of Acute Kidney Disease (AKI) between groups during hospitalization

Time: 28 days

Description: The secondary outcome "Difference in Katz score between groups" will be evaluated as the difference in Katz Activities of Daily Living between Baseline and day 28. This questionnaire will coincide with the 28-day phone call to assess health status and survival.

Measure: Difference in Katz score between groups

Time: 28 days

Other Outcomes

Description: 1. The exploratory outcome "Effect of nitric oxide on heart function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in heart ultrasound at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in heart ultrasound during the administration of NO comparing pre-treatment, during treatment, and post-treatment.

Measure: Effect of NO gas treatment on cardiovascular hemodynamics assessed using cardiac ultrasound in COVID-19 hypoxemic patients

Time: 96 hours

Description: 2. The secondary outcome "Effect of NO gas on lung function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in spirometry at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in spirometry during the administration of NO comparing pre-treatment, during treatment, and post-treatment.

Measure: Effect of NO gas treatment on lung function evaluated with serial spirometry in COVID-19 hypoxemic patients

Time: 96 hours
19 Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia

The severity of COVID-19 is related to the level of hypoxemia, respiratory failure, how long it lasts and how refractory it is at increasing concentrations of inspired oxygen. The inability to perform hematosis due to edema that occurs from acute inflammation could be attenuated by the administration of hyperbaric oxygen (HBO). Recently, it has been reported benefits in this matter in patients with SARS-CoV-2 hypoxemic pneumonia in China; where the administration of repeated HBO sessions decreased the need for mechanical ventilation (MV) in patients admitted to the Intensive Care Unit due to COVID-19. Hyperbaric oxygen is capable of increasing drastically the amount of dissolved oxygen in the blood and maintain an adequate supply oxygen to the tissues. In addition to this, it can influence immune processes, both humoral and cellular, allowing to reduce the intensity of the response inflammatory and stimulate antioxidant defenses. HBO is considered safe and it has very few adverse events, it is a procedure approved by our authorities regulatory for several years. In the current context of the pandemic by COVID-19 and worldwide reports of mortality associated with severe cases of respiratory failure, it is essential to propose therapeutical strategies to limit or decrease respiratory compromise of severe stages by COVID-19. That is why, it is proposed to carry out this research to assess whether HBO treatment can improve the evolution of patients with COVID-19 severe hypoxemia.

NCT04477954
Conditions
  1. Covid19
Interventions
  1. Combination Product: Hyperbaric Oxygen
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Time to normalize the oxygen requirement: Allowing a pulse oximetry value in ambient air greater than or equal 93% and/or arterial blood gas with PaO2 value greater than 60 mmHg in ambient air.

Measure: Time to normalize the oxygen requirement (oxygen dependence)

Time: 15-30 days.

Secondary Outcomes

Description: Number of patients who required IMV after being enrolled

Measure: Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS)

Time: 30 days

Description: Number of patients who required IMV and / or had a diagnosis of ARDS after being enrolled.

Measure: Development of Acute Respiratory Distress Syndrome (ARDS)

Time: 30 days

Description: Number of patients who died in that period since enrollment

Measure: 30-day mortality

Time: 30 days

Description: Number of patients with hypotension who were administered vasopressors in this period

Measure: Hypotension with vasopressor requirement

Time: 30 days

Description: Number of patients who died in that period since enrollment.

Measure: Mortality

Time: 45 days / 60 days / 90 days and 180 days

Other Outcomes

Description: Number of adverse events reported related to the device (Revitalair 430 hyperbaric chamber): otalgias, ear obstruction, barotrauma, significant and constant changes in blood pressure, heart rate and others

Measure: Adverse events

Time: 4 hours finished session
20 Higher vs. Lower Doses of Dexamethasone in Patients With COVID-19 and Severe Hypoxia

We aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia.

NCT04509973
Conditions
  1. Covid19
  2. Hypoxia
Interventions
  1. Drug: Dexamethasone
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28

Measure: Days alive without life support at day 28

Time: Day 28 after randomisation

Secondary Outcomes

Description: Serious adverse reactions defined as new episodes of septic shock, invasive fungal infection, clinically important gastrointestinal bleeding or anaphylactic reaction

Measure: Number of participants with one or more serious adverse reactions

Time: Day 28 after randomisation

Description: Death from all causes

Measure: All-cause mortality at day 28

Time: Day 28 after randomisation

Description: Death from all causes

Measure: All-cause mortality at day 90

Time: Day 90 after randomisation

Description: Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 90

Measure: Days alive without life support at day 90

Time: Day 90 after randomisation

Description: Number of days alive and out of hospital not limited to the index admission

Measure: Days alive and out of hospital at day 90

Time: Day 90 after randomisation

Description: Death from all causes

Measure: All-cause mortality at day 180

Time: Day 180 after randomisation

Description: Assessed by EQ-5D-5L

Measure: Health-related quality of life at day 180

Time: Day 180 after randomisation

Description: Assessed by EQ-VAS

Measure: Health-related quality of life at day 180

Time: Day 180 after randomisation
21 Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic

Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example. This study aim at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation : 1. SARS-CoV-2 infections 2. Postoperative hypoxemic acute respiratory failure

NCT04534400
Conditions
  1. SARS-CoV-2 Infection
  2. Respiratory Failure With Hypoxia
Interventions
  1. Radiation: thoracic CT-scan
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Measure: Correlation between altered pulmonary volume and ordinal severity scale

Time: 2 days after CT scan

Secondary Outcomes

Measure: Correlation between altered pulmonary volume and ordinal severity scale

Time: 7 days after CT scan
22 The Effects of Wearing a Face Mask During COVID-19 on Blood and Muscle Oxygenation While Performing Exercise

There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. This study will assess the effect of wearing two different face masks (disposable and cloth) on blood and muscle oxygenation during cycling exercise.

NCT04557605
Conditions
  1. Hypoxemia
Interventions
  1. Other: Progressive cycling exercise test to exhaustion
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: time to exhaustion

Measure: Time to exhaustion during exercise

Time: Up to 20 minutes

Description: Peak power output in Watts, determined on a cycle ergometer

Measure: Change from baseline in peak power output

Time: Up to 20 minutes

Secondary Outcomes

Description: Blood oxygen saturation as determined by pulse oximetry

Measure: Change from baseline in blood oxygen saturation

Time: Up to 20 minutes

Description: Tissue oxygenation index (oxygenated hemoglobin/total hemoglobin) as measured by near infra-red spectroscopy

Measure: Change from baseline in quadriceps tissue oxygenation index

Time: Up to 20 minutes

Description: Rating of perceived exertion on a scale of 1-10 (Modified Borg Scale), a higher score indicates a greater perceived exertion

Measure: Change from baseline in rating of perceived exertion

Time: Up to 20 minutes

Description: Heart rate (beats per minute)

Measure: Change from baseline in heart rate

Time: Up to 20 minutes
23 Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

NCT04565106
Conditions
  1. Covid19
  2. Hypoxemic Respiratory Failure
  3. Hypoxemia
Interventions
  1. Device: Closed-loop control of oxygen supplementation by O2matic
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Time in SpO2 target of 92-96 %

Measure: Time in SpO2 target

Time: 1 week

Secondary Outcomes

Description: Time with SpO2 not more than 2 % outside target

Measure: Time with SpO2 not more than 2 % outside target

Time: 1 week

Description: Time with SpO2 more than 2 % outside target

Measure: Time with SpO2 more than 2 % outside target

Time: 1 week

Description: Time with SpO2 < 85 %

Measure: Time with SpO2 < 85 %

Time: 1 week
24 The Measurement of VItal SIgns by Lifelight® Data Collect Software in comparisON to the Standard of Care in Acutely Unwell Patients - The VISION-Acute Study

AIM: We propose an innovative approach using Lifelight® smart technology that will enable the continued provision of high level patient care at the same time as reducing pressure on nursing and equipment resources. METHOD : Lifelight® is a computer program ("app") which can be used on smart devices that contain a camera. It is able to measure all of the vital signs by measuring very small changes in skin colour that occur each time the heart beats. This means that it does not need to touch the patient. We believe this could be an effective way of measuring vital signs, especially during the COVID-19 pandemic when prevention of cross-contamination between patients is essential. Patients are also likely to be reassured by a contactless approach. During this study, we will recruit two groups of people who are hospitalised with an acute illness. The first group will be people expected to have abnormal blood oxygen levels such as those with acute respiratory problems including those with COVID-19. The second group will be people expected to have abnormal blood pressure. These Lifelight vital signs will be compared to measurements from standard clinical equipment. The exact number of participants recruited will depend on how quickly the app "learns" and how many of the vital signs collected are outside of the normal range. For the first group of participants, we will use a camera to collect data about the changes in their face and use this to teach the app how to measure blood oxygen level and also to check how well the app measures blood oxygen level, heart rate and respiratory rate. For the second group of participants, we will use a camera to collect data about the changes in their face to check how well the app measures blood pressure and respiratory rate. All of the data will be kept secure and participants will not be able to be identified.

NCT04589923
Conditions
  1. Hypertension
  2. Hypoxia
  3. Hypotension
Interventions
  1. Device: Lifelight® Data Collect Blood Pressure Group
  2. Device: Lifelight® Data Collect Oxygen Saturation Group
MeSH:Hypotension Hypoxia
HPO:Hypotension Hypoxemia

Primary Outcomes

Description: Train Lifelight® oxygen saturation algorithms with hypoxic individuals.

Measure: Primary Objective

Time: 3 months

Secondary Outcomes

Description: Measure oxygen saturation using Lifelight® with accuracy closer to +/- 4%.

Measure: Secondary Objective 1

Time: 3 months

Description: Measure heart rate using Lifelight® with accuracy closer to RMSE of 3bpm.

Measure: Secondary Objective 2

Time: 3 months

Description: Measure respiratory rate using Lifelight® with tolerance accuracy closer to 100% of readings within 5 breaths per minute.

Measure: Secondary Objective 3

Time: 3 months

Description: Measure systolic and diastolic blood pressure using Lifelight® with accuracy closer to 5+/- 8mmHg.

Measure: Secondary Objective 4

Time: 3 months
25 The Effects of Two Systems Above Low-flow Nasal Cannula on Arterial Oxygen Tension in Patients With COVID-19 : Surgical Face Mask Versus Double-trunk Mask

This study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).

NCT04629989
Conditions
  1. Covid19
  2. Hypoxemia
Interventions
  1. Other: Standard Oxygen Delivery System
  2. Other: Double-Trunk Mask
  3. Other: Surgical Mask
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system

Measure: Changes in PaO2

Time: At baseline and 30 minutes after wearing the randomized oxygen delivery system

Secondary Outcomes

Description: Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.

Measure: Change in PaCO2

Time: At baseline and 30 minutes after wearing the randomized oxygen delivery system

Description: Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.

Measure: Change in pH

Time: At baseline and 30 minutes after wearing the randomized oxygen delivery system

Description: Respiratory rate is measured during one minute by visual inspection.

Measure: Change in respiratory rate

Time: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system

Description: Dyspnea is rated with a visual analogic scale (0 to 100mm).

Measure: Change in dyspnea

Time: At baseline and 60 minutes after wearing the randomized oxygen delivery system

Description: The O2 output will be adjusted to recover the baseline SpO2 reading. The O2 output will be read from the position of the ball inside the flowmeter.

Measure: Change in O2 output

Time: At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
26 Silent Hypoxia and Awake Proning in COVID-19 Patients: Home Monitoring and Self-Reporting

The Investigators want to examine patients infected with SARS-CoV-2 for the phenomenon "Silent Hypoxia", which is clinically significant hypoxia without corresponding degree of dyspnea. The patient population is infected individuals without any serious symptoms and is at home. The participants will be equipped with a pulse oximeter and a PEF-measurement device. Four times daily the participants will register saturation, degree of dyspnea and PEF. If the participants experience desaturation or increasing dyspnea, physiotherapy is to be performed, and if that doesn't relieve symptoms or increase oxygen saturation, the hospital should be contacted for admission. The first part of this study is a feasibility study, and if found feasible, the investigators will expand the study to more participants.

NCT04647747
Conditions
  1. Covid19
  2. Hypoxemia
Interventions
  1. Other: Self measurement with pulse oximeter
MeSH:Hypoxia
HPO:Hypoxemia

Primary Outcomes

Measure: Number of patients who manage to perform daily measurements of SpO2

Time: January 30, 2021

Measure: Incidence rate of silent hypoxia in non-hospitalized COVID-19

Time: January 30, 2021

Measure: Association between silent hypoxia and other subjective and objective measurements of disease severity

Time: January 30, 2021

Secondary Outcomes

Measure: Effect of a self-managed physiotherapy program on alleviating hypoxia

Time: January 30, 2021

Measure: Rate of persistent silent hypoxia episode per patients

Time: January 30, 2021

Measure: Rate of silent hypoxia episode per patients

Time: January 30, 2021

Measure: Rate of hospital admission and ICU admission

Time: January 30, 2021

Measure: Incidence of thromboembolic event in outpatients diagnosed with COVID-19

Time: January 30, 2021
27 AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19

The study is an unblinded, randomized, controlled trial for use of the AirFlO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR >20 breaths/min) and/or hypoxia (Oxygen saturation <94% on room air or requiring supplemental oxygen at baseline).

NCT04649775
Conditions
  1. Corona Virus Infection
  2. Respiratory Rate
  3. Hypoxia
  4. Covid19
Interventions
  1. Device: AirFLO2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Tachypnea Hypoxia
HPO:Hypoxemia Tachypnea

Primary Outcomes

Description: Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio inspired oxygen- P:F ratio (PaO2:FiO2), a higher value indicates better oxygenation. Range 20 to 500.

Measure: Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio

Time: change from baseline compared to one to six hours after initial device intervention

Secondary Outcomes

Description: Improved symptoms related to dyspnea as measured by the change in the Modified Medical Research Council (MMRC).. Range 0 to 4 with lower values being better.

Measure: Subject dyspnea symptoms

Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)

Description: Improved symptoms related to cough as measured by the change in Leicester Cough Questionnaire (LCQ) questionnaire, score range 3-21, a higher score indicates better quality of life.

Measure: Subject cough symptoms

Time: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients

Description: Improve subjective symptoms related to cough as measured by the change in St George Respiratory Questionnaire (SGRC) questionnaire, score range 0-100, a higher score indicates worse quality of life.

Measure: Subject respiratory symptoms

Time: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients

Description: Reduce risk of respiratory deterioration as measured by change from baseline to end of hospitalization (discharge or patient death) to high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or invasive ventilation

Measure: Reduced risk progression of respiratory deterioration

Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)

Description: Reduced intensive care unit (ICU) transfer risk, as measured by a change from baseline to end of hospitalization of ICU admission.

Measure: Reduced risk of ICU transfer

Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)

Description: Reduce risk for intubation requirement as measured by incidence of intubation occurring between baseline and end of hospitalization (discharge or death)

Measure: Reduced risk for intubation

Time: baseline to end of hospitalization, (discharge from hospital, or death, 1 - 30 days range)

Description: Reduced hospitalization length of stay as measured by length of hospitalization after the baseline timepoint.

Measure: Reduced hospitalization length of stay

Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)

Description: Increased patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death)

Measure: Increased patient survival to discharge

Time: baseline to end of hospitalization, (discharge from hospital- 1 - 30 days expected range)
28 Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment: Expanded Access Protocol for Patients With COVID-19 Associated ARDS Who Do Not Qualify for Phase II Randomized Control Trial

Infusion Treatment Using Bone Marrow Mesenchymal Stem Cell (bmMSC) Derived Extracellular Vesicle Product, ExoFlo™, for COVID-19 Associated ARDS (EXIT COVID-19), is currently being studied in Protocol DB-EF-PhaseII-001 in patients with COVID-19 associated moderate to severe Acute Respiratory Distress Syndrome (ARDS). This expanded access protocol is an open-label study intended to provide ExoFlo to critically ill patients who do not qualify for the Phase II randomized controlled trial because they: - Do not meet phase II eligibility criteria at current phase II sites. - Do meet phase II eligibility criteria but cannot access phase II sites. - Do not meet phase II eligibility criteria & cannot access phase II sites. •

NCT04657458
Conditions
  1. Covid19
  2. ARDS
  3. Hypoxia
  4. Cytokine Storm
Interventions
  1. Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment
MeSH:Hypoxia
HPO:Hypoxemia

29 Monitoring of COVID-19 Using Urine POC Kit

Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and in infected patients, it produces symptoms which range from completely asymptomatic to those expressing severe illness. Early recognition of those developing severe manifestations allows for rapid and appropriate intervention, including admission to intensive care unit and intensive care therapy, such as mechanical ventilation. A current problem is that only limited data exist predicting the clinical course of COVID-19. This study will determine whether non-invasive urinalysis is useful in assessing and predicting the severity or clinical course of patients with COVID-19.

NCT04681040
Conditions
  1. Covid19
  2. Urine
  3. Biomarker
  4. Acute Respiratory Failure With Hypoxia
MeSH:Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Urine L-FABP will be measured to detect the risk in COVID-19 confirmed cases focusing to no symptom, mild case, and moderate case. Urine beta2 microglobulin will be measured to detect the risk in COVID-19 confirmed cases. Urine L-FABP and beta2 microgloburin will be combined to examine the improvement on risk classification. The risk to develop hypoxic condition, adopted from NEJM 382:1787, 2020 (PMID: 32187464), will be pre-determined by single or dual urine biomarkers using definite cut-off values.

Measure: Risk Stratification of COVID-19 Participants Using Urine Biomarkers

Time: 10 days after starting the initial examination.

Description: The treatment efficacy of a certain specific treatment (ex. dexamethasone, tocilizumab, remdesivir, ivermectin, favipiravir, Hydroxychloroquine, etc) to COVID-19 will be predicted through the initial urine L-FABP level in mild to moderate cases.

Measure: Prediction of COVID-19 Treatment by Urine L-FABP

Time: 14 days after starting the initial intervention.

Secondary Outcomes

Description: Applicability of urine L-FABP and beta2 microgloburin will be measured. Single urine biomarker (L-FABP or beta2 microgloburin) or those combination will be evaluated for predictions such as; i) increase of O2 & respiratory supports, ii) increase of hospital days, iii) worsening level of chest X-ray & CT, and iv) survival rate and SOFA in ICU. At 14 and/or 30 days after the inclusion these clinical parameters will be evaluated based on the cut off value of single urine biomarker (L-FABP or beta2 microgloburin) and those aggregates.

Measure: Increase of O2 support, hospital days, worsening of chest X-ray and CT, and survival rate, at 14 and/or 30 days.

Time: 30 days after starting the initial examination.

Description: Urine L-FABP and beta2 microgloburin will be measured. Single urine biomarker (L-FABP or beta2 microgloburin) or those combination will be compared with d-Dimer and IL-6 for the risk evaluation of COVID-19 in te scope of Outcome 3.

Measure: Comparison of Risk Stratification with Other Biomarkers

Time: 7 days and 10 days after starting the initial examination.
30 Safety and Efficacy Evaluation of a Low-cost CPAP Device for Hypoxemic COVID-19 Patients: A Pilot Study

The aim of this study is to evaluate the preliminary safety and performance of a low-cost locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for hypoxemic COVID-19 patients. The device administers Continuous Positive Airway Pressure (CPAP) therapy using the jet-mixing or Venturi effect to increase the volume flow rate of oxygenated air from a pressurized cylinder by entraining the atmospheric air. To provide CPAP therapy, this high flow of oxygenated air is delivered to the patient via a low-cost non-vented mask with a tight seal with a High-Efficiency Particulate Air (HEPA) filter connected to the exhalation limb. The tight seal and HEPA filter ensures a minimal risk of aerosol generation and thus the device can be used without a negative pressure room. The system consists of the developed Venturi-based flow-generator, a standard 22mm breathing tube, a standard Y-connector, a non-vented CPAP mask (e.g., snorkel mask, helmet), a HEPA filter, and a Positive End Expiratory Pressure (PEEP) valve. The bench-top testing of the device is done in the laboratories of BUET and was verified that the device performs within the CPAP guidelines provided by the Medicines and Healthcare products Regulatory Agency (MHRA), UK. This study aims to assess the safety of and efficacy of the device in three different steps: (1) design validation, (2) clinical feasibility and (3) pilot clinical trial for safety and efficacy evaluation. Only if the device successfully passes the parts 1 and 2, the investigators will proceed to the final clinical trial in step 3. In this final step, the investigators aim to conduct a randomized controlled trial (RCT) evaluating for non-inferiority of the CPAP intervention compared to standard HFNO treatment. The number of ventilator-free days will be used as the primary outcome for efficacy, while patient recovery, death, or need of intubation and other adverse events will be used as secondary outcomes.

NCT04681859
Conditions
  1. Covid19
  2. Hypoxemia
Interventions
  1. Device: High Flow Nasal Oxygen (HFNO) treatment
  2. Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet
MeSH:Hyp Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: The total number of days the patient was able to avoid being placed under a mechanical ventilator.

Measure: Number of ventilator-free days

Time: 10 days

Secondary Outcomes

Description: The event that the patient has recovered and released from the hospital within 30 days.

Measure: Recovery of the patient

Time: 30 days

Description: The event that the patient dies or requires to be placed under a mechanical ventilator.

Measure: Death or need of intubation

Time: 10 days

Description: Oxygen toxicity or other adverse event rating according to the CTCAE scale (1-5)

Measure: Oxygen toxicity or other adverse events

Time: 10 days

HPO Nodes


Reports

Data processed on January 01, 2021.

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.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook