1.
ClinicalTrials.gov; 07/08/2023; TrialID: NCT05990517
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05990517
ABSTRACT
Condition:
Diabetes After Total PancreatectomyIntervention:
Biological: YD01-2022Primary outcome:
C-peptide changeCriteria:
Inclusion Criteria:
1. Voluntarily sign an informed consent form and comply with the trial treatment plan and
visit schedule.
2. Age =18 years and =60 years on the day of signing the informed consent form, regardless
of gender.
3. Diagnosed with chronic pancreatitis and indication for total pancreatectomy. 4.
Post-total pancreatectomy, experiencing elevated blood glucose levels and meeting the
diagnostic criteria for diabetes (World Health Organization, 2019 edition).
5. Post-mixed meal stimulation, C-peptide level <0.3 ng/mL at 120 minutes. 6. Sexually
active males who are not surgically sterilized or have partners of childbearing potential
agree to use effective contraception during the entire trial period and for at least 6
months after the study ends; sexually active females of childbearing potential agree to use
effective contraception during the entire study period and for at least 6 months after the
study ends.
1. History of diabetes or preoperative diagnosis of hyperglycemia, meeting the diagnostic
criteria for diabetes.
2. Previous pancreatic or islet transplantation.
3. Uncontrolled hypertension, such as systolic blood pressure (SBP) >160 mmHg and/or
diastolic blood pressure (DBP) >100 mmHg despite stable dose (at least 4 weeks) of
antihypertensive medication.
4. Known hemoglobin-related diseases, anemia (moderate to severe), or other known
hemoglobinopathies that interfere with HbA1c measurement (such as sickle cell
disease).
5. Impaired liver or kidney function at screening (reference range from the study
center's laboratory): aspartate aminotransferase (AST) >3 times the upper limit of
normal (ULN), alanine aminotransferase (ALT) >3 times ULN, total bilirubin level (TBL)
>2 times ULN (excluding Gilbert's syndrome). Creatinine clearance rate <45 mL/min
(calculated by the Cockcroft-Gault formula).
6. Significant albuminuria (urinary albumin excretion rate >300 mg/g) or history thereof.
7. Uncontrolled thyroid disease or adrenal insufficiency.
8. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with
peripheral blood hepatitis B virus (HBV) DNA =104 copies or =2000 IU/mL (HBsAg
positive with HBV DNA <2000 IU/mL (<104/mL) must receive antiviral treatment
throughout the study; HBcAb positive with HBV DNA <2000 IU/mL (<104/mL) require
regular monitoring of HBV DNA quantification throughout the study); Hepatitis C virus
(HCV) antibody positive with peripheral blood HCV RNA =103 IU/mL; Human
immunodeficiency virus (HIV) antibody positive; Active syphilis infection (cured cases
may be included); Cytomegalovirus (CMV) DNA positive; Positive nucleic acid test for
novel coronavirus (COVID-19).
9. Severe heart disease or a history of cardiovascular disease within 6 months before
screening, including stroke, decompensated heart failure (NYHA class III or IV),
myocardial infarction, unstable angina, or coronary artery bypass grafting.
10. Previous history of coagulation disorders or requiring long-term anticoagulant therapy
(e.g., warfarin) (low-dose aspirin therapy is allowed) or patients with INR >1.5.
11. Substance abusers with a history of drug abuse/dependence or drug use within 1 year
before screening.
12. Received live virus vaccines within the past 6 months or planned to receive live virus
vaccines during the trial or within 1 month after treatment. Live vaccines include,
but are not limited to, measles, mumps, rubella, varicella, yellow fever, rabies,
Bacillus Calmette-Guérin, typhoid vaccine, COVID-19 vaccine, etc.
13. Previous history of pancreatic cancer, intraductal papillary mucinous neoplasm of the
pancreas, end-stage lung disease, or liver cirrhosis.
14. Other abnormal laboratory test results deemed clinically significant by the
investigator.
15. Patients with severe mental illness.
16. Participated in a drug or medical device clinical trial within the past 3 months and
received investigational drugs or medical devices; or within 5 half-lives of another
drug before screening (if the half-life exceeds 3 months).
17. Currently receiving long-term (continuous for =14 days) systemic pharmacological doses
of glucocorticoids or other medications that may affect the participant's
consciousness.
18. Treatment (local, intra-articular, intraocular, or inhalation preparations) for any
other factors or diseases not mentioned above, deemed unsuitable for participation in
this clinical study by the investigator.
2.
ClinicalTrials.gov; 07/08/2023; TrialID: NCT05990530
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05990530
ABSTRACT
Condition:
Brittle Type 1 DiabetesIntervention:
Biological: YD02-2022Primary outcome:
Residual ß-Cell function (RBCF)Criteria:
Inclusion Criteria:
1. Voluntarily sign an informed consent form and agree to comply with the trial treatment
plan and visit schedule.
2. Age =18 years and =60 years on the day of signing the informed consent form,
regardless of gender.
3. Body mass index (BMI) =18.0 kg/m2 and =35.0 kg/m2.
4. Diagnosed with T1DM based on the World Health Organization's diabetes classification
(2019).
5. HbA1c =7.0% and =15.0% at screening.
6. Dependence on insulin injection therapy for =5 years, receiving a stable insulin
treatment plan for =3 months, and injecting insulin three or more times per day or
using an insulin pump.
7. Postprandial mixed meal stimulated C-peptide level <0.3 ng/mL.
8. Experienced impaired awareness of hypoglycemia or significant glycemic instability
during screening and in the past 6 months. Hypoglycemic episodes are associated with
impaired awareness of hypoglycemia, extreme glycemic instability, or severe fear and
maladaptive behavior.
9. Sexually active males who are not surgically sterilized or have partners of
childbearing potential agree to use effective contraception during the entire trial
period and for at least 6 months after the study ends; sexually active females of
childbearing potential agree to use effective contraception during the entire study
period and for at least 6 months after the study ends.
Exclusion Criteria:
1. Types of diabetes other than T1DM.
2. Body mass index (BMI) >35 kg/m2 or weight <50 kg.
3. Excessive insulin sensitivity and/or insulin resistance (insulin requirement >1.0
IU/kg/day or <15 U/day).
4. Previous pancreatic or islet transplantation. Severe trauma, severe infection, or
surgery that may affect glycemic control within one month before screening.
5. History of hypertension with systolic blood pressure (SBP) >160 mmHg and/or diastolic
blood pressure (DBP) >100 mmHg after stable dose (at least 4 weeks) of
antihypertensive medication.
6. Blood transfusion or severe bleeding within the past 3 months, known
hemoglobin-related diseases, anemia (moderate to severe), or other known
hemoglobinopathies that interfere with HbA1c measurement (such as sickle cell
disease).
7. Impaired liver or kidney function at screening: aspartate aminotransferase (AST) =3
times the upper limit of normal (ULN), alanine aminotransferase (ALT) =3 times ULN,
total bilirubin level (TBL) =2 times ULN (excluding Gilbert's syndrome), creatinine
clearance rate <45 mL/min (calculated by the Cockcroft-Gault formula).
8. Significant albuminuria (urinary albumin excretion rate >300 mg/g) or history thereof.
9. Uncontrolled or untreated thyroid disease or adrenal insufficiency.
10. Severe diabetic kidney disease or renal insufficiency, proliferative retinopathy,
diabetic foot ulcers, diabetes-related amputation, and/or severe peripheral neuropathy
at screening.
11. Active hepatitis B, hepatitis C, acquired immunodeficiency syndrome, syphilis, or
tuberculosis. Even without clinical evidence of active infection, participants with
laboratory evidence of active infection are also excluded.
12. Severe heart disease or a history of cardiovascular disease within 6 months before
screening, including stroke, decompensated heart failure (NYHA class III or IV),
myocardial infarction, unstable angina, or coronary artery bypass grafting.
13. Previous history of coagulation disorders or requiring long-term anticoagulant therapy
(e.g., warfarin) (low-dose aspirin therapy is allowed) or patients with INR >1.5.
14. Substance abusers with a history of drug abuse/dependence or drug use within 1 year
before screening.
15. Received live vaccines within 14 days before screening or planned to receive live
vaccines during the trial or within 1 month after treatment. Live vaccines include,
but are not limited to, measles, mumps, rubella, varicella, yellow fever, rabies,
Bacillus Calmette-Guérin, typhoid vaccine, COVID-19 vaccine, etc.
16. Patients with a history of acute or chronic pancreatitis, symptomatic gallbladder
disease, pancreatic injury, or other high-risk factors for pancreatitis, or patients
with blood amylase >1.2 times ULN at screening.
17. Other abnormal laboratory test results deemed clinically significant by the
investigator.
18. Patients with severe mental illness.
19. Participated in a drug or medical device clinical trial within the past 3 months and
received investigational drugs or medical devices; or within 5 half-lives of another
drug before screening (if the half-life exceeds 3 months).
20. Currently receiving long-term (continuous for =14 days) systemic pharmacological doses
of glucocorticoids or other medications that may affect the participant's
consciousness.
21. Treatment (local, intra-articular, intraocular, or inhalation preparations) for any
other factors or diseases not mentioned above, deemed unsuitable for participation in
this clinical study by the investigator.
3.
ChiCTR; 2023-05-24; TrialID: ChiCTR2300071753
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300071753
ABSTRACT
Condition:
COVID-19Intervention:
Nirmatrelvir/Ritonavir group:None;Primary outcome:
Plasma concentrations of Nirmatrelvir;Plasma concentrations of Ritonavir;Criteria:
Inclusion criteria: 1. Patients taking Nirmatrelvir/Ritonavir tablets due to COVID-19 infection;2. Age 0-18, gender unlimited;
3. The subjects and their guardians are willing to comply with the procedures and operations specified in the study protocol;
4. The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study.
Exclusion criteria: 1. The subject is known to be allergic to the ingredients contained in any study drug;
2. Subjects taking CYP3A inducers, inhibitors, and other drugs known to affect Nirmatrelvir or Ritonavir concentrations (e.g., carbamazepine, St. John's wort, clarithromycin, itraconazole, ketoconazole, voriconazole, posaconazole, verapamil, phenytoin, rifampicin, oxazepine, phenobarbital);
3. The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.
4.
ChiCTR; 2023-04-14; TrialID: ChiCTR2300070525
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300070525
ABSTRACT
Condition:
COVID-19Intervention:
survival group:none;non-survival group:none;Primary outcome:
28-day mortality;Criteria:
Inclusion criteria: Diagnostic criteria: adult patients (>18 years old) with COVID-19 infection and pneumonia.Inclusion criteria: Clinical data, including age, gender, past history, clinical related blood test indicators including KL-6, completion of chest HRCT examination 48 hours before hospitalization or within 24 hours after hospitalization.
Exclusion criteria: Exclusion criteria: COVID-19 infection without pneumonia, previous interstitial lung disease underlying diseases, and incomplete clinical data.
5.
ChiCTR; 2023-03-24; TrialID: ChiCTR2300069721
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300069721
ABSTRACT
Condition:
Kidney transplantIntervention:
Test group:Tocilizumab;Control group:Normal saline;Primary outcome:
Scr;DGF;Criteria:
Inclusion criteria: 1. Subjects have given written consent to participate in the study2. Renal transplantation in our hospital with regular follow-up
3. Patient sex not restricted, age = 18 years
4. Subjects previously known to have covid-19 must meet the following criteria: be asymptomatic for at least 1 month prior to initiation of screening
5. Donor kidneys receiving DCD, DBD, DBCD donations
Exclusion criteria: 1) Multiple organ transplant recipients
2) Active viral infections such as BK virus (BKV) cytomegalovirus (CMV), EBV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
3) Severe infection is occurring or has a history of infection requiring hospitalization
4) Active TB or latent TB
5) Liver function tests were abnormal: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.0 × the upper limit of normal, bilirubin > 1.5 × the upper limit of normal
6) Neutropenia (< 2 x109 / L) or thrombocytopenia (< 100 x109 / L)
7) History of diverticulitis, inflammatory bowel disease or gastrointestinal perforation
8) Serious medical or psychiatric disorders that, according to the investigator, could interfere with participation in the study
9) Current or recent (within the last 3 months) participation in another clinical drug trial
10) Living kidney transplant recipients
11) Other conditions that the investigator considered unsuitable for enrollment
6.
ChiCTR; 2023-01-16; TrialID: ChiCTR2300067655
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300067655
ABSTRACT
Condition:
COVID-19 patientsIntervention:
Intervention group:F61 injection;Control group:N/A;Primary outcome:
Proportion of subjects who became critically severe within 14 days after first follow-up;Criteria:
Inclusion criteria: To be included in the study, subjects must meet all of the following conditions: (1) age >= 18, male or female;(2) The test result of SARS-CoV-2 RT-qPCR is positive; (3) Classified as severe type according to the tenth trial edition of the Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol issued by the National Health Commission of the People's Republic of China (NHC); (4) Subject (including partner) has no pregnancy planning within 6 months after signing informed consent to study drug administration; (5) The subject is able to communicate well with the investigator, understand and comply with the requirements of the study, and understand and sign the ICF.
Exclusion criteria: Exclusion criteria: Subjects will not be included in this study if they meet any of the following conditions: Disease: (1) The severity of the disease was divided into mild, moderate and critically severe patients; (2) Suspected or confirmed severe, active bacterial, fungal, viral or other infections (other than COVID-19) that investigators believe may pose a risk when taking interventions; (3) One of the following conditions occurred during the screening period :1)ALT or AST> 3xULN; 2)eGFR <60 mL/min; (4) known allergy to the test drug and its components; Prior/concomitant therapy (5) Participated in other drug clinical trials within 3 months before screening; (6) Other factors considered inappropriate to be included in this study. Other exclusion criteria (7) Pregnant and lactating women
7.
ChiCTR; 2023-01-06; TrialID: ChiCTR2300067426
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300067426
ABSTRACT
Condition:
COVID-19 patientsIntervention:
Intervention group:recombinant human anti COVID-19 monoclonal antibody injection (F61 injection);Control group:F61 placebo;Primary outcome:
Proportion of subjects who became severe or above within 8 days of randomization;Criteria:
Inclusion criteria: To be included in the study, subjects must meet all of the following conditions:(1) age = 18, male or female;
(2) The test result of SARS-CoV-2 nucleic acid is positive;
(3) According to the ninth trial edition of the Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol issued by the National Health Commission of the People's Republic of China (NHC), the clinical classification of patients was moderate type;
(4) There is at least one severe risk factor:1. Age = 60; 2. Patients with underlying diseases: cardiovascular and cerebrovascular diseases, chronic lung diseases, diabetes, chronic liver and kidney diseases, tumors and other; 3. Immune dysfunction (AIDS, long-term use of corticosteroids or other immunosuppressive drugs resulting in reduced immune function); 4.Obesity (body mass index =30); 5. heavy smokers; 6. Not vaccinated against COVID-19; 7. Stay in a nursing home or nursing institution for a long time.
(5) COVID-19 symptoms, such as fever, cough, sore throat, nasal congestion, headache, muscle pain, dyspnea, nausea, chills, vomiting, diarrhea, etc;
(6) Subject (including partner) has no pregnancy planning within 6 months after signing informed consent to study drug administration;
(7) The subject is able to communicate well with the investigator, understand and comply with the requirements of the study, and understand and sign the ICF.
Exclusion criteria: Exclusion criteria: Subjects will not be included in this study if they meet any of the following conditions:
Disease:
(1) The severity of the disease was divided into mild, severe and critical patients;
(2) Suspected or confirmed severe, active bacterial, fungal, viral or other infections (other than COVID-19) that investigators believe may pose a risk when taking interventions;
(3) One of the following conditions occurred during the screening period :1)ALT or AST> 3xULN; 2)eGFR <60 mL/min;
(4) known allergy to the test drug and its components;
Prior/concomitant therapy
(5) Patients who received SARS-CoV-2-specific immunoglobulin (including monoclonal antibody) treatment 3 months before screening;
(6) Patients with a history of receiving convalescent COVID-19 plasma therapy 3 months before administration;
Previous/current clinical research experience
(7) Participated in other drug clinical trials within 3 months before screening;
(8) Other factors considered inappropriate to be included in this study.
Other exclusion criteria
(9) Pregnant and lactating women
8.
ChiCTR; 2022-12-19; TrialID: ChiCTR2200066811
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200066811
ABSTRACT
Condition:
Corona Virus Disease 2019 (COVID-19)Intervention:
Investigational drug group:JT001(VV116);Control drug group:Paxlovid;Primary outcome:
SARS-CoV-2 rebound rate assessed by quantative RT-PCR within 60 days after randomization allocation;Criteria:
Inclusion criteria: 1. Participants of 18 years of age or older, at the time of signing of informed consent;2. Participants who have a positive SARS-CoV-2 test result within 5 days before the randomization allocation;
3. All participants need to meet one or more than one of the following high risks for progression to severe COVID-19, including:
(1) Aged >= 60 years ;
(2) BMI > 25 kg/m2;
(3) With diabetes;
(4) With hypertension;
(5) With cardiovascular diseases;
(6) With chronic lung diseases;
(7) With chronic kidney diseases;
(8) With cancer;
(9) With immunosuppressive disease or immunosuppressive treatment.
4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria: 1. Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization;
2. Participants who have SpO2 <= 93% on room air at sea level or PaO2/FiO2 <=300, or respiratory rate >=30 per minute;
3. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation;
4. Participants who have eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion);
5. Participants who have one of the following:
1) ALT or AST>1.5 ULN;
2) eGFR <60 mL/min within the last 30 days;
6. Participants who have known allergies to any of the components used in the formulation of the interventions;
7. Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant;
8. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment);
9. Participants who have received convalescent COVID-19 plasma treatment;
10. Participants use of contraindicated drugs in the Package Insert of nirmatrelvir tablet/ritonavir tablets (co-packaged);
11. Participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed;
12. Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study;
13. Female who is pregnant or breast-feeding or plan to be pregnant within this study period;
14. Male whose wife or partner plan to be pregnant within the study period.
9.
ChiCTR; 2022-10-02; TrialID: ChiCTR2200064302
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200064302
ABSTRACT
Condition:
cognitive impairment, sleep disorder, Parkinson's diseaseIntervention:
Case series:None;Primary outcome:
MMSE;Anxiety and Depression Scales;Non-motor Symptom Screening Scale;RBD scale;Sleep quality index;Criteria:
Inclusion criteria: 1.COVID group1)Hospitalized patients with confirmed COVID-19;
2)Chinese citizens, over 60 years old and under 85 years old, no gender restrictions;
3)The patient has good general health, stable physical conditions, and can be completed independently assessed using all scales;
4)The patient fully knowledges of this study, has good compliance, writes informed consent, and consents to have long-term follow-up evaluations.
2. Normal control group
1)Chinese citizens, over 60 years old and under 85 years old, no gender restrictions;
2)The patient has good general health, stable physical conditions, and can be completed independently assessed using all scales;
4)The patient fully knowledges of this study, has good compliance, writes informed consent, and consents to have long-term follow-up evaluations.
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from this study:
1)have dementia or other cognitive impairments;
2)have pulmonary embolism, osteoarthritis, or other causes of inability to move freely;
3)have severe underlying diseases or tumor history which affect follow-ups;
4)Those who cannot understand the procedures or methods of this clinical study, refuse to participate, or refuse to sign the informed consent forms.
10.
ChiCTR; 2022-07-05; TrialID: ChiCTR2200061874
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200061874
ABSTRACT
Condition:
COVID-19Intervention:
/:/;Primary outcome:
Epidemiological and clinical characteristics of patients with new crown re-positive;Criteria:
Inclusion criteria: 1. Sign the informed consent in writing before participating, aged 18-80 years, regardless of gender;2. Previously infected with the new coronavirus and recovered (turned negative)
3. The CT value of the new coronavirus nucleic acid is lower than 35 again (nucleic acid positive)
4. ECOG activity status score is 0-2 points;
5. Must agree and be able to comply with the research plan.
Exclusion criteria: 1. There are untreated tumors with multiple systemic metastases;
2. Those who have undergone major surgical operations within 28 days before participating in the study;
3. Uncontrolled active bleeding or bleeding tendency;
4. Pregnant or lactating women;
5. New York Heart Association class III or IV congestive heart failure;
6. There are uncontrolled concurrent diseases, and these factors will affect the subject's compliance with the relevant requirements of this study.
11.
ChiCTR; 2022-06-08; TrialID: ChiCTR2200060700
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200060700
ABSTRACT
Condition:
COVID 19Intervention:
Intervention group:Paxlovid combined with routine treatment;Control group:Routine treatment;Primary outcome:
Nucleic acid shedding time;Criteria:
Inclusion criteria: 1.Patients with confirmed COVID-19 and not receiving systematic treatment2.Patients with paxlovid treatment indications in accordance with the diagnosis and treatment scheme for novel coronavirus (trial version 9)
3.Age >= 60
4.All patients who did not have drug contraindications and agreed to paxlovid treatment were included in the trial group
5.All patients who used drugs prohibited to be combined with paxlovid, such as amiodarone, carbamazepine, diazepam and phenobarbital, were included in the control group
6.Voluntary or authorized agent to sign informed consent
Exclusion criteria: 1.Recently, the patients with new coronal infection became negative and then became positive again;
2.Patients with second or more infections.
12.
ChiCTR; 2022-06-03; TrialID: ChiCTR2200060495
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200060495
ABSTRACT
Condition:
Novel Coronavirus Pneumonia (COVID-19)Intervention:
Gold Standard:2019-nCoV nucleic acid detection (Fluorometric real-time PCR);Index test:2019-nCoV Nucleic Acid Rapid Detection Kit (Isothermal Amplification-Colloidal Gold Method);Primary outcome:
Sensitivity;Specificity;Criteria:
Inclusion criteria: 1. Positive group:(1) Subjects who have recently (within 24 hours is recommended) tested positive for novel coronavirus nucleic acid and signed informed consent.
(2) Ct value can be detected by fluorescence PCR.
(3) Aged 18-80 years.
2. Negative group:
(1) Subjects who have been clinically confirmed to exclude novel coronavirus infection and signed informed consent.
(2) Aged 18-80 years.
Exclusion criteria: 1. For subjects who have recently tested positive or negative for the novel coronavirus by fluorescent PCR, the results of the secondary fluorescent PCR test are inconsistent with them, and the results of the repeated fluorescent PCR test are still inconsistent.
2. Pregnant subjects.
13.
ClinicalTrials.gov; 29/05/2022; TrialID: NCT05398705
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05398705
14.
ChiCTR; 2022-05-26; TrialID: ChiCTR2200060296
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200060296
ABSTRACT
Condition:
COVID-19Intervention:
/:/;Primary outcome:
epidemiological and clinical characteristics of asymptomatic and mild COVID-19 patients;Criteria:
Inclusion criteria: 1. The patient is infected with the new coronavirus and confirmed by rtPCR.Exclusion criteria: 1. Fuyang patients;
2. Patients with missing nucleic acid results or other baseline data.
15.
ChiCTR; 2022-05-19; TrialID: ChiCTR2200060113
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200060113
ABSTRACT
Condition:
Novel Coronavirus Pneumonia (COVID-19)Intervention:
Experimental group:Use experimental medical instruments and oxygen-hydrogen atomizing machine (Shanghai Asclepius Meditec Co., Ltd.) + basic treatment (researchers give corresponding symptomatic support treatment according to patients' conditions);Control group:Conventional oxygen supply equipment in the hospital (wall oxygen or cylinder oxygen) + basic treatment;Primary outcome:
Time to negative viral nucleic acid detection from the start of the study treatment;Criteria:
Inclusion criteria: 1. No gender limit, patients aged between 18 and 80 years (inclusive);2. Diagnosed as general type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 9);
3. Patients who are willing to participate and provided written informed consent form.
Exclusion criteria: 1. Subjects in the treatment or active stage of malignant tumor;
2. Subjects with known intolerance to inhalation therapy;
3. Subjects with known mental abnormality or cognitive impairment that prevents informed consent;
4. Subjects with immune dysfunction, long-term use of corticosteroids or other immunosuppressants;
5. Subjects with severe heart, liver and kidney dysfunction or serious primary diseases of the system; Acute exacerbation of chronic obstructive pulmonary disease; Acute attack of bronchial asthma;
6. Non-expectorant antioxidant drugs, including large doses of vitamin C and vitamin E;
7. Subjects participating in clinical trials of other drugs or devices;
8. Pregnant or lactating subjects;
9. Other conditions assessed by the investigator as unsuitable for participation in the study.
16.
ChiCTR; 2022-05-11; TrialID: ChiCTR2200059778
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200059778
ABSTRACT
Condition:
COVID-19Intervention:
Gold Standard:Shanghai Expert Consensus on Comprehensive Treatment of COVID-19;Index test:Predictive models of disease outcome;Primary outcome:
Diagnostic performance;Sensitivity;Specificity;Criteria:
Inclusion criteria: 1. Renal dialysis patients diagnosed with COVID-19;2. All patients with renal dialysis meet the diagnostic criteria of light, common and severe in novel coronavirus in the Expert Consensus of Comprehensive Treatment of Coronavirus in Shanghai in 2019;
3. At least 18 years old;
4. Voluntary participation in the clinical study.
Exclusion criteria: 1. Combined with other serious underlying lung diseases (such as chronic obstructive pulmonary disease, lung tumors, tuberculosis, etc.);
2. Pregnant or lactating patients;
3. Critically ill patients whose survival period is less than 7 days or with insufficient follow-up data;
4. There are many artifacts in the inspection image quality, and the blood sample collection results are abnormal caused by human factors.
17.
ChiCTR; 2022-05-10; TrialID: ChiCTR2200059727
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200059727
ABSTRACT
Condition:
COVID-19Intervention:
Group 1 :Zijin Prescription;Group 2:Conventional treatment;Primary outcome:
COVID-19 nucleic acid;Criteria:
Inclusion criteria: 1. Age and gender are not limited;2. Meet the diagnostic criteria for new coronary pneumonia;
3. Voluntarily accept TCM syndrome differentiation treatment;
4. Informed consent to this research.
Exclusion criteria: 1. Severe and critical patients with new coronary pneumonia;
2. Any other chronic respiratory disease, respiratory bacterial infection such as suppurative tonsillitis, acute tracheo-bronchitis, sinusitis, otitis media and other respiratory diseases that affect the assessment;
3. Accompanied by severe pulmonary interstitial disease, bronchiectasis, primary immunodeficiency disease, congenital respiratory malformation, congenital heart disease, abnormal lung development and other basic diseases;
4. Accompanied by severe liver disease [aspartate aminotransferase (AST), alanine aminotransferase (ALT) exceeds 5 times the upper limit of normal value], or has severe renal insufficiency or is receiving continuous kidney disease substitution therapy, hemodialysis, peritoneal dialysis patients;
5. There are malignant tumors with multiple metastases that cannot be resected, hematological diseases, dyscrasias, active bleeding, severe malnutrition, AIDS (HIV), or severe neurological or mental diseases.
18.
ChiCTR; 2022-05-10; TrialID: ChiCTR2200059725
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200059725
ABSTRACT
Condition:
obstetric anesthesiaIntervention:
Group 1 :;Group 2:;Group 3:;Primary outcome:
postpartum vital signs;postpartum blood loss;Apgar score;Criteria:
Inclusion criteria: 1. Pregnant women infected with the new coronavirus, suspected of being infected with the new coronavirus and normal during the new crown period;2. The patient is 20-50 years old;
3. To be sane;
4. Can communicate normally.
Exclusion criteria: 1. Pregnant women who refuse to participate;
2. Pregnant women with mental diseases;
3. Pregnant women who cannot communicate normally.
19.
ChiCTR; 2022-05-03; TrialID: ChiCTR2200059550
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200059550
ABSTRACT
Condition:
Novel Coronavirus Pneumonia (COVID-19)Intervention:
Experimental group:Low Intensity Pulsed Ultrasound Irradiation;Control group:Pseudostimulus;Autocontrol group:Low Intensity Pulsed Ultrasound Irradiation;Primary outcome:
computer tomography scanning;Criteria:
Inclusion criteria: 1. Patients with novel coronavirus infection, with clinical manifestations of coughing and expectoration, and CT in line with the diagnostic criteria for new coronary pneumonia;2. Be able to cooperate with various inspections during clinical research;
3. Aged 30-80 years, participate voluntarily;
4. The patient or the patient's family agrees and signs the informed consent.
Exclusion criteria: 1. Patients with bronchiectasis and malignant lung tumors;
2. Pregnant and lactating patients;
3. Those who have chest skin damage and cannot wear the LIPUS treatment device;
4. Patients who cannot communicate with researchers or staff;
5. Participate in other clinical investigators at the same time.
20.
ChiCTR; 2022-03-19; TrialID: ChiCTR2200057834
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2200057834
ABSTRACT
Condition:
Novel coronavirus Pneumonia (COVID-19)Primary outcome:
Coronavirus nucleic acid;Criteria:
Inclusion criteria: 1. Aged 18 to 65 years;2. Asymptomatic and mild cases in accordance with the COVID-19 diagnosis and treatment protocol version 9;
3. Subjects who understand and are willing to sign the informed consent and cooperate with the study.
Exclusion criteria: 1. Co-infected with HIV;
2. Co-infected with influenza A and B virus.