1.
ClinicalTrials.gov; 27/10/2023; TrialID: NCT06113432
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06113432
ABSTRACT
Condition:
Pneumonia, Bacterial;Respiratory Failure;COVID-19 PneumoniaIntervention:
Diagnostic Test: Arterial blood gases;Diagnostic Test: Respiratory rate (RR);Diagnostic Test: Pulseoximeter;Diagnostic Test: Assessment of accessory respiratory muscles work;Diagnostic Test: Esophageal pressure measurement;Diagnostic Test: Discomfort Visual Analog Scale (VAS);Diagnostic Test: Noninvasive blood pressure;Diagnostic Test: Heart ratePrimary outcome:
Inspiratory effort;Inspiratory delta transpulmonary pressure (stress);Expiratory delta transpulmonary pressureCriteria:
Inclusion Criteria:
- Patients with acute hypoxemic respiratory failure due to community-acquired pneumonia
or COVID-19
- The ratio of the partial pressure of oxygen in arterial blood to the inspiratory
fraction of oxygen (PaO2/FiO2) is less than 250 mm Hg while breathing atmospheric air
- Respiratory rate more than > 25 per minute.
- Written informed consent
Exclusion Criteria:
- Patients who achieve the following target parameters with only low-flow oxygen therapy
(flow up to 15 l/min): SpO2 > 93%, the patient does not have a subjective feeling of
fatigue, there is no visible work of the auxiliary respiratory muscles of the neck,
- Unstable hemodynamics (systolic blood pressure <90 mm Hg or mean arterial pressure <65
mm Hg) and/or lactic acidosis (lactate >5 mmol/l and/or clinically diagnosed shock)
and/or life-threatening arrhythmia,
- Metabolic acidosis (pH <7.30);
- Patients who were in the ICU for less than 24 hours for any reason
- Primary or secondary lung diseases (exacerbation of chronic obstructive pulmonary
disease (COPD), bronchial asthma, interstitial lung diseases, metastatic lung disease)
- Cardiogenic pulmonary edema,
- Chronic diseases in the stag e of decompensation with the development of
extrapulmonary organ dysfunction (liver cirrhosis, progression of cancer, CHF),
- Glasgow Coma Scale score <14 points,
- Swallowing disorders
- Hypercapnia (PaCO2>45 mmHg),
- The need for urgent tracheal intubation for any reason,
- Recent head surgery or anatomy that prevents the placement of a helmet or full face
mask on the patient,
- Pregnancy,
- Inability to cooperate with staff
2.
ClinicalTrials.gov; 07/04/2023; TrialID: NCT05808361
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05808361
ABSTRACT
Condition:
Rehabilitation;Pneumonia, Viral;COVID-19;Quality of LifeIntervention:
Other: exercises;Other: massagePrimary outcome:
Length of stay in hospitalCriteria:
Inclusion Criteria:
- patients with COVID-19 admitted to the hospital with mild or moderate COVID-19 (5-50%
of lung damage according to CT-scan)
Exclusion Criteria:
- less than 7 days in hospital by any reason,
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumour
progression, liver cirrhosis, congestive heart failure), admission to ICU, atonic
coma,
- patients in whom more than 30 days have passed since the onset of the disease and
before hospitalization,
- patients who received treatment in the intensive care unit, as well as patients who
died.
3.
ClinicalTrials.gov; 05/11/2022; TrialID: NCT05608603
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05608603
ABSTRACT
Condition:
COVID-19;Endothelial Function;Diastolic Dysfunction;Oxygen Consumption;Quality of Life;Exercise ToleranceIntervention:
Diagnostic Test: Portable cardiac monitor "CardioQvark";Diagnostic Test: Cardiorespiratory stress test;Diagnostic Test: Analysis of exhaled air using the Compact PTR-MS proton mass spectrometerPrimary outcome:
Changes in endothelin-1 in dynamics (compared with initial indicators);Changes in the diastolic function of the right and left ventricles (compared with initial indicators);Change in ejection fraction (compared with initial indicators);Changes in the volumes of the heart cavities (compared with initial indicators);Change in speed indicators on the heart valves (compared with initial indicators);Change in mean and diastolic pressure of the pulmonary artery (compared with initial indicators);Changes in the cardio-ankle vascular index and ankle-brachial index (compared with initial indicators);Changes in the spectrum of volatile organic compounds in exhaled air in patients after COVID-19 infection over time (compared with initial indicators);Change in oxygen pulse (VO2/HR) at the peak of the load;Changes in ventilation parameters (tidal volume (Vt), minute ventilation (VE), Vt/FVC index (ratio of tidal volume to forced vital capacity), respiratory reserve (BR)) over time;Changes in gas exchange parameters (end-expiratory partial pressure of exhaled carbon dioxide (PetCO2), ventilation equivalent for carbon dioxide (VE/VCO2), ventilation-perfusion ratio (Vd/Vt)) in dynamicsCriteria:
Inclusion Criteria:
1. Written informed consent to participate in the study;
2. Age 18 and over;
3. Male and female;
4. COVID-19 infection confirmed by laboratory tests (polymerase chain reaction testing,
enzyme-linked immunosorbent assay (positive result at least 1 time) with a CT degree
more that 25% of lung lession.
5. No more than 3 months after discharge from infectious department
Non-inclusion criteria:
1. Unable to sign informed consent;
2. Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive
psychosis);
3. Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism within the
last 3 months;
4. Oncology;
5. Diseases and conditions that can change the ECG picture and complicate the analysis of
the ECG (conduction disturbance, pacemaker);
6. Inability to use a heart monitor (congenital developmental anomalies, traumatic
amputation of the upper limbs, essential tremor, Parkinson's disease);
7. Severe comorbidities with life expectancy less than 1 year.
Exclusion Criteria:
1. Refusal to further participation in the study;
2. Acute infectious diseases, tuberculosis
3. Oncology arising in the process of the study
4. Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism arising in
the process of the study
5. Acute psychotic reactions arising in the process of the study;
6. Inability to use a heart monitor arising in the process of the study
4.
ClinicalTrials.gov; 30/04/2022; TrialID: NCT05379608
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05379608
ABSTRACT
Condition:
COVID-19;Chronic Heart Failure;Hypertension;Arrhythmia;Conduct Disorder;Chronic Coronary Syndrome;Endothelial Dysfunction;Diastolic Dysfunction;Oxygen Consumption;Quality of Life;Exercise ToleranceIntervention:
Procedure: Intermittent hypoxic-hyperoxic training;Procedure: Intermittent hypoxic-hyperoxic training/controlPrimary outcome:
Change in the levels of proinflammatory cytokines.;Change of the endothelial function;Changes in indicators of diastolic dysfunction.Criteria:
Inclusion Criteria:
1. Written informed consent to participate in the study;
2. Age 40 and over;
3. Male and female;
4. One or more cardiovascular pathologies in the anamnesis:
- a reliably confirmed diagnosis of hypertension, stage I-III (the diagnosis was
made in accordance with the National Clinical Guidelines - 2019);
- stable angina pectoris I-III functional class, confirmed by complaints, anamnesis
and physical examination and with the help of diagnostic tests (bicycle ergometry
or daily electrocardiography monitoring);
- confirmed diagnosis of arrhythmias and conduction disorders based on
electrocardiography data and 24-hour Holter monitoring (premature depolarization,
supraventricular tachycardia, atrial fibrillation, sick sinus syndrome,
atrioventricular block I-II, bundle branch blocks);
- chronic heart failure stage I-IIB, I-III functional class (New York Heart
Association Functional Classification), confirmed by the presence of clinical
signs and at least one of two criteria: myocardial dysfunction of left ventricle
or / and an increase in the level of the N-terminal fragment of brain natriuretic
peptide over 125 pg / ml;
- the presence of signs of systolic or diastolic dysfunction of the left ventricle
according to echocardiography.
5. COVID-19 infection confirmed by laboratory tests (polymerase chain reaction testing,
enzyme-linked immunosorbent assay (positive result at least 1 time) with a CT degree
of 3 or higher.
Non-inclusion criteria:
1. Acute infectious diseases, tuberculosis;
2. Chronic somatic diseases in the acute stage;
3. Congenital anomalies of the heart and large vessels;
4. Valvular heart defects (congenital and acquired);
5. Severe atherosclerosis of the lower extremities'vessels (chronic ischemia of the lower
extremities,stage 3-4);
6. Acute decompensated heart failure (II-IV class according to Killip classification);
7. Chronic heart failure IV functional class (New York Heart Association Functional
Classification classification);
8. Secondary arterial hypertension;
9. Acute coronary syndrome within 4 weeks before the start of the study;
10. Life-threatening rhythm and conduction disturbances;
11. Bronchial asthma with the development of respiratory failure II-III degree;
12. Acute cerebrovascular accident within the last 4 months;
13. Chronic kidney disease (glomerular filtration rate<30 ml / min / 1.73 m2 via CKD-EPI
(chronic kidney disease epidemiology collaboration) formula);
14. Pregnancy;
15. Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive
psychosis);
16. Oncology, diagnosed within a year or receiving a course of radiation / chemotherapy
for cancer at the present time;
17. Severe cognitive impairment (MOS) and clinically significant anxiety and / or
depression (HADS) interfering with observation;
18. Individual intolerance to oxygen deficiency.
Exclusion Criteria:
1. Refusal to further participation in the study;
2. Acute psychotic reactions arising in the process of the study;
3. Exacerbation of chronic diseases, requiring a change in patient management tactics and
preventing his or her further participation in the study.
5.
ClinicalTrials.gov; 15/06/2021; TrialID: NCT04933864
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04933864
ABSTRACT
Condition:
SARS-CoV-2Intervention:
Drug: Methylene Blue and Photodynamic TherapyPrimary outcome:
The percentage of participants with negative quantitative Polymerase Chain Reaction test on SARS-CoV-2 on day 2 after methylene blue administration and photodynamic therapyCriteria:
Inclusion Criteria:
- signed informed consent
- age: 18-90 years
- positive quantitative Polymerase Chain Reaction test on SARS-CoV-2 infection
- negative pregnancy test in women
- any severity of pneumonia (computer tomography scans)
Non-inclusion Criteria:
- documented refusal to participate in the study
- treatment with a serotonergic drug
- connection to artificial lung ventilation with or without sedation
- history of G-6-Phosphatase deficiency
- pregnancy and breastfeeding
- medical records of cirrhosis
- active chronic hepatitis
Exclusion Criteria:
- myocardial infarction, developed after the patient was included in the study, but
before the intervention
- bleeding, developed after the patient was included in the study, but before the
intervention
- connection to artificial lung ventilation developed after the patient was included in
the study, but before the intervention
6.
ClinicalTrials.gov; 07/04/2021; TrialID: NCT04854941
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04854941
ABSTRACT
Condition:
Coronavirus InfectionIntervention:
Other: ProbioticsPrimary outcome:
MortalityCriteria:
Inclusion Criteria:
- patients with COVID-19 infection confirmed by polymerase chain reaction of
nasopharyngeal and oropharyngeal swabs to the causative agent of this infection
- age from 18 to 75 years old from December 2020 to April 2021
Exclusion Criteria:
- the patient's decision to withdraw from the study
- refusing to take the probiotic for a reason not related to the development of side
effects.
Non-inclusion criteria:
- age over 75 years old or under 18 years old,
- taking probiotics for 3 months prior to admission
- history of intolerance to probiotics or their components
- refusal to participate and sign informed consent
- pregnancy or breastfeeding
- presence of cancer or psychoemotional disorders
- renal failure at the time of admission (glomerular filtration rate less than 50 ml /
min)
- hepatic failure at the time of admission (equivalent to cirrhosis class B or C on the
Child-Pugh scale)
7.
ClinicalTrials.gov; 10/02/2021; TrialID: NCT04750317
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04750317
ABSTRACT
Condition:
COVID-19Intervention:
Drug: TofacitinibPrimary outcome:
Death;Mechanical ventilationCriteria:
Inclusion Criteria:
1. SARS-CoV2 Infection diagnosed by PCR and/or typical lesions on CT-scan (4 or 5 on
CO-RADS scale) in combination with at least one of the following:
- oxygen saturation at rest =93% on ambient air,
- AND/OR C-reactive protein =50 mg/L,
- AND/OR fever (=38.0°C) that persisted for at least two days despite treatment
with nonsteroidal antiinflammatory drugs or paracetamol
2. Written Informed Consent
Exclusion Criteria:
1. Age <18 years
2. Coexistent infection other than COVID-19
3. Requirement for invasive mechanical ventilation
4. Estimated glomerular filtration rate calculated using CKD-EPI formula =30 ml/min/1.73
m2;
5. Elevated ALT and/or AST levels more than 3 times the upper limit of normal
6. Chronic use of glucocorticoids or immunosuppressive agents
7. Administration of interleukin-6 inhibitors and/or high-dose glucocorticoids (=250 mg
prednisone equivalent intravenously) for the treatment of COVID-19
8.
ClinicalTrials.gov; 09/02/2021; TrialID: NCT04752085
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04752085
ABSTRACT
Condition:
Covid19;SARS-CoV InfectionIntervention:
Diagnostic Test: Chitotriosidase activityPrimary outcome:
Need in biological therapy or/and respiratory supportCriteria:
Inclusion Criteria:
- Hospitalisation with COVID-19
Exclusion Criteria:
- History of hospitalisation with COVID-19 infection
- Discharge from the hospital before the end of the treatment course
- Transfer to another hospital
9.
ClinicalTrials.gov; 17/01/2021; TrialID: NCT04716179
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04716179
ABSTRACT
Condition:
Covid19;Fertility IssuesIntervention:
Diagnostic Test: Sperm test;Diagnostic Test: hormone levels (testosterone, FSH, LH, prolactin);Diagnostic Test: SARS-CoV-2 Ig G levels;Other: Testis pathology samplesPrimary outcome:
Semen quality analysis - motility;Semen quantity analysis;Semen quality analysis - shapeCriteria:
Inclusion Criteria:
- Clinical or imaging signs of COVID-19 infection
- Nasopharyngeal swab positive for SARS-CoV2 mRNA
Exclusion Criteria:
- Inability to collect semen for analysis
- Congenital anomalies of the testes
- Varicocele
- A history of fertility disorders
10.
ClinicalTrials.gov; 11/12/2020; TrialID: NCT04667923
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04667923
ABSTRACT
Condition:
Covid19;ARDSIntervention:
Diagnostic Test: Respiratory monitoring;Diagnostic Test: Respiratory muscles ultrasound;Diagnostic Test: Electro impedance tomography;Diagnostic Test: Capnography;Diagnostic Test: Arterial blood gas;Diagnostic Test: Quasistatic pressure-volume curvePrimary outcome:
Intubation rate;MortalityCriteria:
Inclusion Criteria:
- at least one of the following criteria: fatigue, Patrick scale 5 points, SpO2<92% on
standard oxygen therapy (<15 l/min) or continuous positive airway pressure
(CPAP)-therapy with oxygen flow<15 l/min
Exclusion Criteria:
- pregnancy
- age less than 18 or more than 80 years
- life-threatening heart rhythm abnormalities and/or systolic blood pressure < 80 mmHg
despite norepinephrine at a dose > 2 µg/kg/min
- primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumour
metastases in lungs
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumour
progression, liver cirrhosis, congestive heart failure)
- Glasgow cona score < 14
- inability to swallow
- upper airways obstruction
11.
JPRN; 18/11/2020; TrialID: JPRN-UMIN000042489
Clinical Trial Register
| ICTRP | ID: ictrp-JPRN-UMIN000042489
ABSTRACT
Condition:
CompletedPrimary outcome:
Dexamethasone therapy in SARS-CoV-2 patients significantly improved CT score and appear to decrease mortality rate.Criteria:
Inclusion criteria:Exclusion criteria: Dexamethasone intake for prior 6 month, anti-interleukin drugs admission
12.
ClinicalTrials.gov; 22/06/2020; TrialID: NCT04445961
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04445961
ABSTRACT
Condition:
SARS PneumoniaIntervention:
Diagnostic Test: Respiratory mechanics measurement;Diagnostic Test: Gas exchange measurementPrimary outcome:
Optimum positive end-expiratory pressure (PEEP) level;Optimum positive end-expiratory pressure (PEEP) level;Number of patients with recruitable lung;Number of patients with recruitable lungCriteria:
Inclusion Criteria:
- all patients with COVID-19 and acute respiratory failure on invasive and noninvasive
ventilation
Exclusion Criteria:
- Patients who reached the following goals at conventional oxygen therapy (oxygen flow <
15 l/min): peripheral capillary oxygen saturation(SpO2) > 93%, no visible work of
auxiliary respiratory muscles, no fatigue, stable hemodynamics (no need in any
catecholamines and/or life-threatening heart rhythm abnormalities),
- less than 24 ours in intensive care unit (ICU) by any reason,
- lung emphysema,
- primary lung diseases (chronic obstructive lung disease-COPD, interstitial lung
diseases, etc) or tumour metastases in lungs,
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumour
progression, liver cirrhosis, congestive heart failure),
- atonic coma.
13.
ClinicalTrials.gov; 11/05/2020; TrialID: NCT04386564
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04386564
ABSTRACT
Condition:
COVID-19;Kidney InjuryIntervention:
Diagnostic Test: mRNA in urine testPrimary outcome:
The effect of COVID-19 severity on the severity of renal failureCriteria:
Inclusion Criteria:
- Pneumonia confirmed by CT scans
Exclusion Criteria:
- a history of chronic renal failure;
- a history of kidney transplantation;
- intake of substances with a history of renal toxicity (no later than a month before
inclusion);
- patients with a single kidney;
- refusal of the patient to participate in the study;
- absence of SARS-CoV-2 virus smear from the nasopharynx in PCR.