Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1059 | Double-Trunk Mask Wiki | 0.27 |
| drug3214 | Surgical Mask Wiki | 0.19 |
| drug3542 | VibroLUNG Wiki | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1614 | Infectious Disease and Cardiology Clinical Consultations Wiki | 0.19 |
| drug1100 | ELMO PROJECT AT COVID-19: STUDY IN HUMANS Wiki | 0.19 |
| drug3162 | Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Wiki | 0.19 |
| drug1247 | FT516 Wiki | 0.19 |
| drug3124 | Standard Oxygen Delivery System Wiki | 0.19 |
| drug2164 | Nitric Oxide-Continuous and Sessions Wiki | 0.19 |
| drug1786 | Lifelight® Data Collect Blood Pressure Group Wiki | 0.19 |
| drug3263 | TXA127 Wiki | 0.19 |
| drug2994 | Self-prone position recommendation Wiki | 0.19 |
| drug3136 | Standard interface Wiki | 0.19 |
| drug2166 | Nitric Oxide-Sessions Wiki | 0.19 |
| drug181 | AirFLO2 Wiki | 0.19 |
| drug491 | Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment Wiki | 0.19 |
| drug3076 | Sodium Chloride 9mg/mL Wiki | 0.19 |
| drug2316 | Oxygen gas Wiki | 0.19 |
| drug779 | Closed-loop control of oxygen supplementation by O2matic Wiki | 0.19 |
| drug1627 | Inhaled nitric oxide (iNO) Wiki | 0.19 |
| drug1099 | ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY Wiki | 0.19 |
| drug3567 | Viruxal Oral and Nasal Spray Wiki | 0.19 |
| drug329 | Awake proning Wiki | 0.19 |
| drug3165 | Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki | 0.19 |
| drug2983 | Self measurement with pulse oximeter Wiki | 0.19 |
| drug2314 | Oxygen Hood Wiki | 0.19 |
| drug2442 | Pioglitazone Wiki | 0.19 |
| drug4051 | thoracic CT-scan Wiki | 0.19 |
| drug2607 | Progressive cycling exercise test to exhaustion Wiki | 0.19 |
| drug3164 | Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Wiki | 0.19 |
| drug1787 | Lifelight® Data Collect Oxygen Saturation Group Wiki | 0.19 |
| drug1882 | MK-5475 Wiki | 0.19 |
| drug3163 | Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Wiki | 0.19 |
| drug1526 | Hyperbaric Oxygen Wiki | 0.19 |
| drug1741 | L-ascorbic acid Wiki | 0.13 |
| drug2167 | Nitrogen gas Wiki | 0.13 |
| drug1717 | Ivermectin Pill Wiki | 0.13 |
| drug1053 | Dornase Alfa Inhalation Solution [Pulmozyme] Wiki | 0.13 |
| drug2925 | SOC Wiki | 0.13 |
| drug3046 | Silmitasertib Wiki | 0.13 |
| drug3505 | Usual care Wiki | 0.11 |
| drug1467 | Hydrocortisone Wiki | 0.11 |
| drug2621 | Prone positioning Wiki | 0.09 |
| drug1000 | Dexamethasone Wiki | 0.05 |
| drug2174 | No intervention Wiki | 0.04 |
| drug2448 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000860 | Hypoxia NIH | 1.00 |
| D059246 | Tachypnea NIH | 0.19 |
| D012770 | Shock, Cardiogenic NIH | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007022 | Hypotension NIH | 0.19 |
| 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 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030149 | Cardiogenic shock HPO | 0.19 |
| HP:0002615 | Hypotension HPO | 0.19 |
| HP:0002789 | Tachypnea HPO | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0010444 | Pulmonary insufficiency HPO | 0.07 |
| HP:0011947 | Respiratory tract infection HPO | 0.03 |
| HP:0002090 | Pneumonia HPO | 0.03 |
Navigate: Correlations HPO
There are 28 clinical trials
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.
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 hourDescription: 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 dayDescription: 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 dayDescription: 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 daysDescription: proportion of patients improving their arterial saturation within 1 hour of Prone Position
Measure: Evolution of Spo2 Time: 1 hourDescription: 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 dayDescription: proportion of patients intolerant to prone position (Prone Position <1h);
Measure: Intolerance to prone positioning Time: 1 dayDescription: proportion of patients who can maintain prone position for more than 3 h.
Measure: Tolerance to prone positioning Time: 1 dayProne 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.
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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: Discomfort with proning (4-point ordinal scale: very comfortable, somewhat comfortable, somewhat uncomfortable, very uncomfortable)
Measure: Discomfort with proning Time: up to 30 daysDescription: Total number of days hospitalized will be abstracted from the electronic medical record.
Measure: Length of hospital stay Time: up to 30 daysDescription: Invasive mechanical ventilation will be abstracted from the electronic medical record.
Measure: Invasive mechanical ventilation Time: up to 30 daysDescription: 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 daysDescription: ARDS diagnosis will be abstracted from the electronic medical record
Measure: Acute respiratory distress syndrome (ARDS) diagnosis Time: up to 30 daysDescription: Hospital mortality will be abstracted from the electronic medical record
Measure: Hospital mortality Time: up to 30 daysThis study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.
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 systemsDescription: 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 systemsDescription: 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 DTMDescription: 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 DTMDescription: 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 DTMDescription: Respiratory rate is measured during one minute by visual inspection.
Measure: Changes in respiratory rate Time: At baseline and 30 minutes after wearing both systemsThe 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.
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 daysDescription: The number of days a patient is hospitalized
Measure: Duration of hospitalization Time: up to 10 daysDescription: Early mortality from all causes will be estimated
Measure: The frequency of early mortality Time: up to 30 daysDescription: Late mortality from all causes will be estimated
Measure: The frequency of late mortality Time: up to 90 daysDescription: 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 daysWe aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19 and severe hypoxia.
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 randomisationDescription: Death from all causes
Measure: All-cause mortality at day 28 Time: Day 28 after randomisationDescription: 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 randomisationDescription: Death from all causes
Measure: All-cause mortality at day 90 Time: Day 90 after randomisationDescription: 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 randomisationDescription: 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 randomisationDescription: Death from all causes
Measure: All-cause mortality at 1 year after randomisation Time: 1 year after randomisationDescription: Assessed by EQ-5D-5L
Measure: Health-related quality of life at 1 year Time: 1 year after randomisationDescription: Assessed by EQ-VAS
Measure: Health-related quality of life at 1 year Time: 1 year after randomisationPrevious 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.
Description: Occurrence of adverse events during study drug infusion
Measure: Incidence of adverse events Time: Days 1-4Description: Occurrence of serious adverse events during study drug infusion
Measure: Incidence of serious adverse reactions Time: Days 1-4Description: Occurrence of adverse reactions during study drug infusion
Measure: Incidence of adverse reactions Time: Days 1-4Description: Documented days free off mechanical ventilation the first 28 days post enrollment
Measure: Ventilator-free days Time: Days 1-28Description: Documented days free of ICU admission the first 28 days post enrollment
Measure: ICU-free days Time: Days 1-28Description: Documented days free of hospital admission the first 28 days post enrollment
Measure: Hospital-free days Time: Days 1-28Description: Incidence of mortality at 28 days by all causes
Measure: All-cause mortality Time: Days 1-28Description: 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 1-4Description: The difference in serum CRP during HDIVC infusion reported in mg/dL
Measure: C-reactive protein (CRP) Time: Days 1-4Description: The difference in LDH during HDIVC infusion will be reported in IU/L
Measure: Lactate dehydrogenase (LDH) Time: Days 1-4Description: The difference in D-dimer during HDIVC infusion will be reported in ug/mL
Measure: D-dimer Time: Days 1-4Description: The difference in lymphocyte count during HDIVC infusion will be reported in 10e3/uL
Measure: Lymphocyte count Time: Days 1-4Description: 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 1-4Description: 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 1-4An 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).
Description: Analysing stabilisation of C-reactive protein
Measure: Measuring the change in inflammation Time: 7 daysDescription: How many patients that are still alive
Measure: Number of patients that are alive at 28 days Time: 28 daysDescription: How many days on oxygen
Measure: Amount of days that patient requires oxygen Time: 7 daysDescription: Calculating index with Fi02, mean airways pressure and Pa02 via https://www.mdcalc.com/oxygenation-index#use-cases
Measure: Average oxygenation index Time: 7 daysDescription: How many days as an inpatient
Measure: Days patient admitted to hospital Time: 7 daysDescription: How many patients require mechanical ventilation
Measure: Percentage of patients that need mechanical ventilation Time: 7 daysThis 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.
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 FT516In 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.
Description: age in years
Measure: Age Time: at baselineDescription: male/female
Measure: Gender Time: at baselineDescription: in kilograms
Measure: Weight Time: at baselineDescription: in meters
Measure: Height Time: at baselineDescription: weight and height combined to calculate BMI in kg/m^2
Measure: BMI Time: at baselineDescription: 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 baselineDescription: 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 baselineDescription: in dd-mm-yyyy or mm-dd-yyyy
Measure: Date of signs of COVID-19 infection Time: at baseline or date of occurenceDescription: in dd-mm-yyyy or mm-dd-yyyy
Measure: Date of positive swab Time: at baseline or date of occurenceDescription: in days
Measure: Pre-ECMO length of hospital stay Time: at or during ECMO-implantDescription: in days
Measure: Pre-ECMO length of ICU stay Time: at or during ECMO-implantDescription: in days
Measure: Pre-ECMO length of mechanical ventilation days Time: at or during ECMO-implantDescription: y/n, what kind
Measure: Use of antibiotics Time: up to 6 monthsDescription: y/n, what kind
Measure: Use of anti-viral treatment Time: up to 6 monthsDescription: y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
Measure: Use of second line treatment Time: up to 6 monthsDescription: respiratory or cardiac
Measure: Indications for ECMO-implant Time: at ECMO-implantDescription: veno-venous, veno-arterial or veno-venoarterial
Measure: Type of ECMO-implant Time: at ECMO-implantDescription: peripheral or central
Measure: Type of access Time: at ECMO-implantDescription: in dd-mm-yyyy or mm-dd-yyyy
Measure: Date of ECMO implant Time: at ECMO-implantDescription: 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 monthsDescription: 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 monthsDescription: y/n
Measure: ECMO configuration change Time: up to 6 monthsDescription: in dd-mm-yyyy or mm-dd-yyyy
Measure: Date of ECMO configuration change Time: up to 6 monthsDescription: veno-venous, veno-arterial, veno-venoarterial, other
Measure: New ECMO configuration Time: up to 6 monthsDescription: right ventricular failure, left ventricular failure, refractory hypoxemia
Measure: Indications for ECMO configuration change Time: up to 6 monthsDescription: 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 monthsDescription: 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 monthsDescription: amount of ECMO circuit changes (1, 2, 3 etc.)
Measure: Frequency of ECMO circuit change Time: up to 6 monthsDescription: Hemorrhagic, infection, other complications
Measure: ECMO complications Time: up to 6 monthsDescription: y/n
Measure: ECMO Weaning Time: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 monthsDescription: 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 monthsDescription: Ward, another ICU, rehabilitation center, home
Measure: Type of discharge Time: up to 6 monthsPatients 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.
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.
Description: As assessed per treating physician's discretion.
Measure: Incidence of treatment emergent adverse events Time: Up to 14 daysDescription: Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.
Measure: Incidence of adverse events Time: Up to 6 hoursDescription: Incidence of increase to > 5% total methemoglobin as assessed by pulse oximetry.
Measure: Incidence of methemoglobinemia Time: Up to 14 daysDescription: 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 daysDescription: The number of days until hypoxemia is resolved as per treating physician assessment
Measure: Time until resolution of hypoxemia Time: Up to 14 daysDescription: Incidence of death during hospitalization and after discharge up to 28 days
Measure: Incidence of mortality Time: Up to 28 daysDescription: Number of days of hospitalization
Measure: Duration of hospitalization Time: Up to 28 daysTo 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.
Description: Continuous pulse oximetry monitoring
Measure: Oxygen saturation Time: 3/6/2020 - 5/1/2020Description: Intubation/mechanical Ventilation at any point during hospitalization.
Measure: In-hospital Intubation/Mechanical Ventilation Status Time: 3/6/2020 - 5/1/2020Description: In-hospital Mortality status
Measure: In-hospital Mortality Time: 3/6/2020 - 5/1/2020Description: Duration of hospitalization
Measure: Length of Hospitalization Time: 3/6/2020 - 5/1/2020The 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.
Description: SpO2 was measured by peripheral pulse oximetry.
Measure: Change in SpO2 Time: Before proning and 1 hour after initiation of the prone positionDescription: 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 admissionThe 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.
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 21Description: 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 7Description: 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)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
Description: Regression of respiratory failure under the influence of vibroacoustic therapy
Measure: Recovery respiratory fail Time: 5-7 daysThe 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.
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 testsDescription: 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 testsDescription: 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 testsDescription: 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 testsDescription: 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 testsDescription: 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 testsPioglitazone 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.
Description: Number and type of adverse events
Measure: Adverse events outcomes without attribution Time: Baseline, until 30 days after last doseDescription: Number and type of adverse events
Measure: Adverse events attributable Time: Baseline, until 30 days after last doseDescription: Disease severity as measured by 7 point ordinal scale
Measure: Clinical improvement Time: Baseline, until 30 days after last doseDescription: Type of oxygen support treatment
Measure: Levels of treatment Time: Baseline, until 30 days after last doseDescription: Change from Baseline of d-Dimer
Measure: d-Dimer Time: Baseline, until 30 days after last doseDescription: Change from Baseline of CRP
Measure: C Reactive Protein Time: Baseline, until 30 days after last doseDescription: Change from Baseline of Ferritin
Measure: Ferritin Time: Baseline, until 30 days after last doseDescription: Change from Baseline of Lactate dehydrogenase
Measure: Lactate dehydrogenase Time: Baseline, until 30 days after last doseDescription: Change from Baseline of A1c
Measure: A1c Time: Baseline, until 30 days after last dosePreliminary 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).
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 hoursDescription: 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 hoursDescription: 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 hoursDescription: 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 hoursDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 hoursDescription: 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 hoursThe 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.
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.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 daysDescription: 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 daysDescription: Number of patients who died in that period since enrollment
Measure: 30-day mortality Time: 30 daysDescription: Number of patients with hypotension who were administered vasopressors in this period
Measure: Hypotension with vasopressor requirement Time: 30 daysDescription: Number of patients who died in that period since enrollment.
Measure: Mortality Time: 45 days / 60 days / 90 days and 180 daysDescription: 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 sessionWe 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.
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 randomisationDescription: 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 randomisationDescription: Death from all causes
Measure: All-cause mortality at day 28 Time: Day 28 after randomisationDescription: Death from all causes
Measure: All-cause mortality at day 90 Time: Day 90 after randomisationDescription: 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 randomisationDescription: 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 randomisationDescription: Death from all causes
Measure: All-cause mortality at day 180 Time: Day 180 after randomisationDescription: Assessed by EQ-5D-5L
Measure: Health-related quality of life at day 180 Time: Day 180 after randomisationDescription: Assessed by EQ-VAS
Measure: Health-related quality of life at day 180 Time: Day 180 after randomisationAutomated 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
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.
Description: time to exhaustion
Measure: Time to exhaustion during exercise Time: Up to 20 minutesDescription: Peak power output in Watts, determined on a cycle ergometer
Measure: Change from baseline in peak power output Time: Up to 20 minutesDescription: Blood oxygen saturation as determined by pulse oximetry
Measure: Change from baseline in blood oxygen saturation Time: Up to 20 minutesDescription: 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 minutesDescription: 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 minutesDescription: Heart rate (beats per minute)
Measure: Change from baseline in heart rate Time: Up to 20 minutesPatients 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.
Description: Time in SpO2 target of 92-96 %
Measure: Time in SpO2 target Time: 1 weekDescription: Time with SpO2 not more than 2 % outside target
Measure: Time with SpO2 not more than 2 % outside target Time: 1 weekDescription: Time with SpO2 more than 2 % outside target
Measure: Time with SpO2 more than 2 % outside target Time: 1 weekDescription: Time with SpO2 < 85 %
Measure: Time with SpO2 < 85 % Time: 1 weekAIM: 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.
Description: Train Lifelight® oxygen saturation algorithms with hypoxic individuals.
Measure: Primary Objective Time: 3 monthsDescription: Measure oxygen saturation using Lifelight® with accuracy closer to +/- 4%.
Measure: Secondary Objective 1 Time: 3 monthsDescription: Measure heart rate using Lifelight® with accuracy closer to RMSE of 3bpm.
Measure: Secondary Objective 2 Time: 3 monthsDescription: Measure respiratory rate using Lifelight® with tolerance accuracy closer to 100% of readings within 5 breaths per minute.
Measure: Secondary Objective 3 Time: 3 monthsDescription: Measure systolic and diastolic blood pressure using Lifelight® with accuracy closer to 5+/- 8mmHg.
Measure: Secondary Objective 4 Time: 3 monthsThis 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).
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 systemDescription: 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 systemDescription: 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 systemDescription: 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 systemDescription: 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 systemDescription: 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 systemThe 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.
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).
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 interventionDescription: 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 patientsDescription: 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 patientsDescription: 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)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. •
Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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.
Drug Reports MeSH Reports HPO Reports