1.
ClinicalTrials.gov; 30/11/2023; TrialID: NCT06162533
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06162533
ABSTRACT
Condition:
COVID-19Intervention:
Biological: Vaccination against SARS-CoV-2Primary outcome:
COVID-19 deathCriteria:
Inclusion Criteria:
- Residency in Austria.
Exclusion Criteria:
- None.
2.
ClinicalTrials.gov; 09/10/2023; TrialID: NCT06105346
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06105346
ABSTRACT
Condition:
Conscripts;Military Induction Board;ENT Disease;Rhinosinusitis Chronic;Rhinosinusitis;HPV Infection;HPV Vaccine;Long COVID;ENT SurgeryPrimary outcome:
Prevalence of rhinosinusitis;Prevalence of human papilloma virus vaccination;Prevalence of hearing impairment;Prevalence of long-COVID diseaseCriteria:
Inclusion Criteria:
- participation of the military induction board of conscripts
- consent for participation obtained by the conscripts
- completed questionnaire (with at least 50% completeness of each subcategory)
- participation of medical examination
Exclusion Criteria:
- no consent for participation in the study by the conscripts
- incomplete questionnaire (with less than 50% completeness of each subcategory)
- no participation of medical examination.
3.
ClinicalTrials.gov; 28/08/2023; TrialID: NCT06035926
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06035926
ABSTRACT
Condition:
Symptoms Recoding SARS-CoV-2 After VaccinationIntervention:
Other: questionnairePrimary outcome:
Occurrence of symptoms after the respective vaccinationCriteria:
Inclusion Criteria:
- Employees with appropriate indication (>4 months after the second vaccination)
according to the recommendations of the national vaccination committee.
- Signed vaccination information sheet.
Exclusion Criteria:
- no booster vaccination.
4.
ClinicalTrials.gov; 14/12/2022; TrialID: NCT05652634
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05652634
ABSTRACT
Condition:
Long COVID;Acute COVID-19Primary outcome:
Symptom persistence beyond four weeks from the onset of acute symptoms of COVID-19 (subacute/ongoing symptomatic COVID-19).Criteria:
Inclusion Criteria:
- Adults (>18 years); qPCR-test positive for SARS-CoV-2 infection; symptom(s) of acute
COVID-19; inclusion within defined timeframe of one week after testing; data
collection online, by phone and at study visits feasible
Exclusion Criteria:
- Insufficient knowledge of German language; lengths of hair at rear vertex less than 2
cm; pregnancy or postpartum less than 3 months; refusal to give informed consent
5.
ClinicalTrials.gov; 01/12/2021; TrialID: NCT05142540
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05142540
ABSTRACT
Condition:
Anti-SARS-CoV-2 Antibody ResponseIntervention:
Procedure: blood and saliva samples will be takenPrimary outcome:
Immunoglobulin (Ig)A concentrations to anti-SARS (severe acute respiratory syndrome)-CoV-2 spike protein in saliva.;IgG concentrations to anti-SARS-CoV-2 spike protein in saliva.;IgM concentrations to anti-SARS-CoV-2 spike protein in saliva.Criteria:
Inclusion Criteria:
1. Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine
and decided to receive a booster vaccination as recommended by national guidelines. -
Exclusion Criteria:
1. Presence of diseases or therapies that are likely to interfere with the immune
response to booster vaccination.
2. Any contraindications to the vaccine planned to receive as listed in the product
characteristics.
3. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
4. Having already received a third (booster) vaccination with any COVID-19 vaccine.
5. Women who are pregnant or breastfeeding.
6. Persons who are not willing to sign the informed consents (biobank informed consent
and study specific informed consent) -
6.
EU Clinical Trials Register; 16/11/2021; TrialID: EUCTR2021-006172-16-AT
Clinical Trial Register
| ICTRP | ID: ictrp-EUCTR2021-006172-16-AT
ABSTRACT
Condition:
Covid (Coronavirus disease)- 19 immunisationMedDRA version: 23.1 Level: PT Classification code 10084457 Term: COVID-19 immunisation System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Intervention:
Trade Name: Comirnaty concentrate for dispersion for injection
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: COVID-19 mRNA Vaccine
Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Trade Name: Spikevax dispersion for injection
COVID-19 mRNA Vaccine (nucleoside modified)
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: COVID-19 mRNA Vaccine
Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Primary outcome:
Main Objective: Quantitative and functional comparison of the salivary anti-SARS-CoV-2 antibody response before and after 3rd booster vaccination. ;Secondary Objective: To answer the following research questions:1. Is there a difference in concentration and persistence of salivary antibodies between the various primary vaccines before and after the 3rd booster vaccination?
2. Is there any difference in the neutralizing capacity of salivary antibodies between the various primary vaccines before and after the 3rd booster vaccination towards the various SARS-CoV-2 variants?
3. Do saliva and serum antibody levels correlate? Is saliva a possible surrogate sample to monitor the antibody response to COVID vaccines?
4. How does the neutralizing capacity of saliva and serum antibodies compare?
5. Are different salivary antibody profiles in terms of quantity and subclasses associated with previous exposure to other respiratory pathogens including endemic coronaviruses?
6. Is a difference in the T cell response associated with different antibody profiles in saliva and serum?;Primary end point(s): IgA, IgG and IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum before the third booster vaccination and 3-8 weeks and 6 months after the third booster vaccination, measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays. ;Timepoint(s) of evaluation of this end point: Before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination
Criteria:
Inclusion criteria:Participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet the following inclusion criteria:
1. Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine and decided to receive a booster vaccination as recommended by national guidelines.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Exclusion criteria:
1. Presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination.
2. Any contraindications to the vaccine planned to receive as listed in the product characteristics.
3. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
4. Having already received a third (booster) vaccination with any COVID-19 vaccine.
5. Women who are pregnant or breastfeeding.
6. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent)
7.
ClinicalTrials.gov; 21/07/2021; TrialID: NCT04972708
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04972708
ABSTRACT
Condition:
Bipolar Disorder;Covid19;StressIntervention:
Genetic: Cross-sectional genetics studyPrimary outcome:
PRS of stress or depression;PRS of COVID-19 infectionCriteria:
Inclusion Criteria:
- Inclusion criteria are written consent after previous written and verbal information,
diagnosis of BD according to DSM-IV and age between 18 and 75 years.
Exclusion Criteria:
Exclusion criteria include
- acute suicidality
- lack of consent
- severe active drug dependence (i.e., alcohol, benzodiazepines, morphine)
- other currently active severe mental / cerebral organic disease (e.g. epilepsy, brain
tumor),
- severe skull-brain trauma / brain surgery in the past,
- known florid tumor disease,
- congenital / infantile mental retardation,
- dementia (from MMSE 20),
- severe florid autoimmune diseases or current immunosuppression (e.g., lupus
erythematosus, HIV, multiple sclerosis),
- cardiac, renal and pulmonary disorders or PTSD or anxiety
- Healthy controls do not have a history of mental disorder and do not have first- or
second-degree relatives with psychiatric disorders.
8.
EU Clinical Trials Register; 19/07/2021; TrialID: EUCTR2021-002984-23-AT
Clinical Trial Register
| ICTRP | ID: ictrp-EUCTR2021-002984-23-AT
ABSTRACT
Condition:
Chronic peritoneal dialysis patients;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Intervention:
Trade Name: Covid-19 Vaccine Moderna
Product Name: COVID-19 Vaccine Moderna
Pharmaceutical Form: Injection
INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified)
CAS Number: PR1
Current Sponsor code: 005791
Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Primary outcome:
Main Objective: The present study aims to determine the serological immune response to the new SARS-CoV-2 vaccine (COVID-19 vaccine Moderna) in patients on chronic PD, as assessed by Roche Elecsys Anti-SARS-CoV2 S (Roche, )which detects antibodies against the SARS-CoV-2 virus (including neutralizing antibodies). Based on this study, conclusions can be drawn on whether the immune response is sufficient or alternative dosing regimens of vaccines might need further exploration.;Secondary Objective: Exploratory analysis: associations between baseline (immune) parameters, age strata (18- 59 and >=60 years of age), frailty score, HBV responder-status (non-responder: HBV titer <10 IE/L, low-responder: HBV titer 10-99 IE/L, responder: anti-HBs titer >100IE/L) with the serological response to the SARS-CoV-2 vaccination.;Primary end point(s): The anti-SARS-CoV2 level (estimated as geometric mean concentration, GMC) in patients on chronic dialysis (peritoneal dialysis) after the vaccination with COVID- 19 vaccine Moderna ;Timepoint(s) of evaluation of this end point: 4 weeks after first vaccination dose and 4 weeks after second vaccination doseCriteria:
Inclusion criteria:18 to 90 years of age
End stage kidney disease patient undergoing peritoneal dialysis
Patient was scheduled to receive an approved SARS-CoV2 vaccine as part of their routinely performed care
Provided written informed consent for the “Bio-Bank”
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion criteria:
No informed consent of the “Bio-Bank” was obtained
9.
ClinicalTrials.gov; 21/04/2021; TrialID: NCT04858607
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04858607
ABSTRACT
Condition:
Covid19;ImmunosuppressionIntervention:
Diagnostic Test: Blood sample;Diagnostic Test: Saliva samplePrimary outcome:
The levels of anti-SARS-CoV-2 spike protein humoral immune response.Criteria:
Inclusion Criteria:
1. Noninfectious immunocompetent participants (i.e., healthy participants) as determined
by medical history and clinical judgement.
or
2. Patients with primary immunodeficiencies or
3. Patients with B-cell depleting therapy due to autoimmune disease or
4. Patients with benign and malignant hematological diseases receiving specific
Treatments with known immunosuppressive effects including cytotoxic agents, systemic
corticosteroids, monoclonal antibodies and targeted therapies.
or
5. Patients with active hematological diseases and secondary immunoglobulin deficiency
(e.g. chronic lymphatic leukemia, MM) currently not receiving specific treatment.
or
6. Patients >3 months but <12 months after autologous HSCT (hematopoietic stem cell
transplantation).
or
7. Patients >3 months but <12 months after allogeneic HSCT. or
8. Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive
therapy.
or
9. Patients with chronic GvHD (graft-versus-host disease) and persistent
immunodeficiency.
Exclusion Criteria:
Healthy participants
1. Presence of diseases or therapies that are likely to interfere with the immune
response to vaccination.
2. Presence of a disease requiring change in therapy during 4 weeks before enrollment.
3. Any contraindications to the vaccine planned to receive as listed in the product
characteristics.
4. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
5. Women who are pregnant or breastfeeding.
6. Previous vaccination with any coronavirus vaccine.
7. Persons who are not willing to sign the informed consents (biobank informed consent
and study specific informed consent).
Immunodeficient participants
1. Patients with hematological diseases within three months from B-cell-depleting
immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells
(Chimeric Antigen Receptor).
2. Patients with hematological malignancies in remission and >12 months after end of
specific therapy.
3. Patients within three months from HSCT.
4. Any contraindications to the vaccine planned to receive as listed in the product
characteristics.
5. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
6. Women who are pregnant or breastfeeding.
7. Previous vaccination with any coronavirus vaccine (exception: if serum prior to
vaccination is available from the biobank).
8. Patients who are not willing to sign the informed consents (biobank informed consent
and study specific informed consent).
10.
EU Clinical Trials Register; 13/04/2021; TrialID: EUCTR2021-001391-42-AT
Clinical Trial Register
| ICTRP | ID: ictrp-EUCTR2021-001391-42-AT
ABSTRACT
Condition:
For assessing the immune cell function after COVID-19 vaccine, peripheral blood mononuclear cells (PBMC) will be separated after blood sampling and measurements as follows will be done: • FACS analysis • DNA and RNA analysis of immune related molecules. • Assays of T-cell function, B-cell function and macrophage/monocyte function;Therapeutic area: Body processes [G] - Immune system processes [G12]Intervention:
Trade Name: Spermidine (spermidineLIFE®, food supplement)
Product Name: SpermidineLIFE (dietary supplement)
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Spermidine
Other descriptive name: Spermidine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Oral suspension in sachet
Route of administration of the placebo: Oral use
Primary outcome:
Main Objective: The primary objective of this feasibility study is to determine the effects of daily Spermidine supplements on the immune response to the Covid-19 vaccine in older people. We will examine if Spermidine improves the age-related impaired immune response to the Covid-19 vaccine and determine the molecular and immunological signature driving immunity.;Secondary Objective: Our secondary objective is to determine the acceptability of daily Spermidine supplements to participants. We will also use data collected to perform a power calculation for future larger studies.;Primary end point(s): FACS analysis in peripheral blood mononuclear cells (PBMC) for deep immune phenotyping (focusing on T- and B-cell subtypes);Timepoint(s) of evaluation of this end point: At baseline, 2 weeks and 4 weeks after first COVID-19 vaccination, further 2 weeks and 26 weeks after 2nd vaccinationCriteria:
Inclusion criteria:1. Capacity to provide written informed consent
2. Age =65 and <90 years at consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Exclusion criteria:
1. Incapacity to provide written informed consent
2. Active signs or symptoms of acute infection at the time of screening
3. Ongoing or previous SARS-CoV-2 vaccination
4. Positive SARS-CoV-2 PCR in the past or during the study period.
5. Glucocorticoid, immunosuppressive or other immune modifying therapy, current or within 3 months prior to first study visit
6. Medical history of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
7. Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation, current or within 3 months prior to first study intervention
8. Medical conditions that can suppress the immune system
9. Any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct.
10. History of liver insufficiency or laboratory evidence of liver dysfunction with aspartate transaminase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal
11. Previous allergy to vaccinations or their constituent parts
12. History of malignancies other than skin
13. Hypersensitivity to Spermidine or to any of its excipients
14. Gluten intolerance
15. Contraindication to vaccination
16. Use of any other investigational drug in the previous 30 days and/or intent on using any investigational drug for the duration of the trial
17. Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
11.
EU Clinical Trials Register; 08/04/2021; TrialID: EUCTR2021-001103-32-AT
Clinical Trial Register
| ICTRP | ID: ictrp-EUCTR2021-001103-32-AT
ABSTRACT
Condition:
Cirrhotic chronic liver disease;Therapeutic area: Body processes [G] - Immune system processes [G12]Intervention:
Trade Name: Comirnaty
Pharmaceutical Form: Concentrate for suspension for injection
INN or Proposed INN: Comirnaty
Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Trade Name: Covid-19 Vaccine Moderna
Pharmaceutical Form: Injection
INN or Proposed INN: Covid-19 Vaccine Moderna
Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Vaxzevria Injection Suspension
Pharmaceutical Form: Injection
INN or Proposed INN: Vaxzevria
Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
Concentration unit: Munit million units
Concentration type: not less then
Concentration number: 250-
Primary outcome:
Main Objective: To assess the immune response to Covid-19 vaccination with a licensed vaccine in chronic liver disease;Secondary Objective: To compare the efficacy of Covid-19 vaccination in patients with chronic liver disease versus healthy individuals;Primary end point(s): plasma concentration of neutralizing SARS-CoV-2 antibodies;Timepoint(s) of evaluation of this end point: baseline, 2 weeks after first vaccination, 2 weeks after second vaccination, month 6, month 12Criteria:
Inclusion criteria:chronic liver disease of any etiology
age above 18 years
signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Exclusion criteria:
allergy to any excipient of the vaccine
pregnancy
expected survival <3 months
12.
EU Clinical Trials Register; 26/03/2021; TrialID: EUCTR2021-001040-10-AT
Clinical Trial Register
| ICTRP | ID: ictrp-EUCTR2021-001040-10-AT
ABSTRACT
Condition:
Active immunisation to prevent COVID-19 in immunocompromised individuals.MedDRA version: 23.1 Level: PT Classification code 10084457 Term: COVID-19 immunisation System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Health Care [N] - Population Characteristics [N01]
Intervention:
Trade Name: Comirnaty concentrate for dispersion for injection
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: COVID-19 mRNA Vaccine
Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Trade Name: Spikevax dispersion for injection
COVID-19 mRNA Vaccine (nucleoside modified)
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: COVID-19 mRNA Vaccine
Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Vaxzevria suspension for injection
COVID-19 Vaccine (ChAdOx1-S [recombinant])
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: COVID-19 Vaccine
Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
Concentration unit: U unit(s)
Concentration type: not less then
Concentration number: 2.5E8-
Primary outcome:
Timepoint(s) of evaluation of this end point: Day 21-28 after the second vaccination.;Main Objective: Characterization of the anti-SARS-CoV-2 humoral immune response after vaccination with a focus on the anti-spike protein response: an analysis in immunocompromised patients compared to healthy controls.;Primary end point(s): The seroconversion leading to anti-SARS-CoV-2 spike protein humoral immune response at day 21-28 after the second vaccination measured by SARS-CoV-2 antigen-binding Ig assay, comparing immunocompromised patients to healthy controls. ;Secondary Objective: Compare T cell response of healthy & immunodeficient subjectDiffernce in seroconversion or T cell response between different vaccines
Impact of immune system´s aging to humoral & cellular immune response
Impact of the various forms of immunosuppression on the vaccine-induced response
Impact of previous SARS-CoV-2 infection and
Role of previous asymptomatic SARS-CoV-2 infection on the vaccine induced response
Compare immune response of the various vaccines & participants
Difference in the induction of secretory IgA and serum IgA in comparison to the serum IgG and IgM response
Influence of previous infections caused by endemic CoV on the vaccine response
Difference in the induction of neutralizing antibodies in subsets of immunocompromised & in COVID-19 recovered individuals compared to COVID-19 naïve controls
Difference in the neutralizing capacity of antibodies after vaccination towards the emerging SARS-CoV-2 variants
Humoral & cellular effect of a booster vaccination
Criteria:
Inclusion criteria:In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet one of the following inclusion criteria:
1. Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
or
2. Patients with primary immunodeficiencies
or
3. Patients with B-cell depleting therapy due autoimmune disease
or
4. Patients with benign and malignant hematological diseases receiving specific treatments with known immunosuppressive effects including cytotoxic agents, systemic corticosteroids, monoclonal antibodies and targeted therapies.
or
5. Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. CLL, MM) currently not receiving specific treatment.
or
6. Patients >3 months but <12 months after autologous HSCT.
or
7. Patients >3 months but <12 months after allogeneic HSCT.
or
8. Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive therapy.
or
9. Patients with chronic GvHD and persistent immunodeficiency.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 195
Exclusion criteria:
Subjects meeting any of the following criteria cannot be enrolled into the trial:
Healthy participants
1. Presence of diseases or therapies that are likely to interfere with the immune response to vaccination.
2. Presence of a disease requiring change in therapy during 4 weeks before enrollment.
3. Any contraindications to the vaccine planned to receive as listed in the product characteristics.
4. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
5. Women who are pregnant or breastfeeding.
6. Previous vaccination with any coronavirus vaccine.
7. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
Immunodeficient participants
1. Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells).
2. Patients with hematological malignancies in remission and >12 months after end of specific therapy.
3. Patients within three months from HSCT.
4. Any contraindications to the vaccine planned to receive as listed in the product characteristics.
5. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
6. Women who are pregnant or breastfeeding.
7. Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank).
8. Patients who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
13.
EU Clinical Trials Register; 22/03/2021; TrialID: EUCTR2021-001459-15-AT
Clinical Trial Register
| ICTRP | ID: ictrp-EUCTR2021-001459-15-AT
ABSTRACT
Condition:
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Intervention:
Trade Name: COVID-19 Vaccine AstraZeneca
Product Name: COVID-19 Vaccine AstraZeneca
Product Code: EMEA/H/C/005675
Pharmaceutical Form: Injection
INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant])
Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
Concentration unit: million IU million international units
Concentration type: not less then
Concentration number: 250-
Trade Name: Comirnaty
Product Name: Comirnaty
Product Code: EMEA/H/C/005735
Pharmaceutical Form: Injection
INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified)
Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Trade Name: COVID-19 vaccine Moderna
Product Name: COVID-19 Vaccine Moderna
Product Code: EMEA/H/C/005791
Pharmaceutical Form: Injection
INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified)
Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: COVID-19 Vaccine Janssen
Product Name: COVID-19 Vaccine Janssen
Product Code: EMEA/H/C/005737
Pharmaceutical Form: Injection
INN or Proposed INN: COVID-19 vaccine (Ad26.COV2-S [recombinant])
Other descriptive name: COVID-19 Vaccine Janssen (Ad26.COV2.S)
Concentration unit: million IU million international units
Concentration type: not less then
Concentration number: 89200-
Primary outcome:
Main Objective: The primary objective is to investigate the short and mid-term humoral immune response to COVID-19 vaccines as assessed by anti-spike protein antibodies in people with diabetes as compared to healthy controls.;Secondary Objective: Secondary objective-to investigate the difference in the short and mid-term humoral immune response to COVID-19 vaccines in people with type 1 and type 2 diabetes, either with good or unsatisfactory glycaemic control.
-to investigate glycaemic excursions and required changes to antihyperglycaemic doses or treatment regimens following COVID-19 vaccination in people with diabetes.
-to investigate changes to the coagulatory system in people with diabetes as compared to healthy controls following COVID-19 vaccination.
-to investigate the safety profile of COVID-19 vaccines in people with diabetes.
;Primary end point(s): Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls.;Timepoint(s) of evaluation of this end point: Baseline and Visit 3 (2-3 weeks after second vaccination)
Criteria:
Inclusion criteria:Inclusion criteria for Diabetes Mellitus Cohort
-Age between 18 and 80 years, both inclusive
-Planned COVID-19 vaccination
Cohort I (Diabetes mellitus Type 1, well controlled)
Glycated haemoglobin levels HbA1c =7.5 %
Cohort II (Diabetes mellitus Type 1, uncontrolled)
Glycated haemoglobin levels HbA1c >7.5 %
Cohort III (Diabetes mellitus Type 2, well controlled)
Glycated haemoglobin levels HbA1c =7.5 %
Cohort IV (Diabetes mellitus Type 2, uncontrolled)
Glycated haemoglobin levels HbA1c >7.5 %
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion criteria:
Exlcusion criteria for Diabetes Mellitus Cohort
-Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
-Pregnancy or intention of becoming pregnant; breastfeeding
-Immunosuppressive therapy
-Acute or chronic inflammatory disorder
-Alcohol abuse (more than 15 drinks / week)
-Any contraindication to the vaccine planned to receive as listed in the product characteristics
-Previous COVID-19 vaccine or episode of COVID-19
14.
ClinicalTrials.gov; 15/03/2021; TrialID: NCT04813718
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04813718
ABSTRACT
Condition:
Covid19Intervention:
Dietary Supplement: Omni-Biotic Pro Vi 5;Dietary Supplement: PlaceboPrimary outcome:
Microbiome composition;Intestinal barrier;sCD14;endotoxin;TNFalpha;Interleukin 1b;Interleukin 6;Interleukin 6 receptor;interleukin 8;interleukin 10;interleukin 17;interleukin 23;neutrophil function burst function;neutrophil function phagocytosis;neutrophil NET formation;neutrophil surface receptor expression;monocyte burst;monocyte phagocytosis;monocyte function surface receptor expression;T cell immunophenotyping;B cells immunophenotyping;Spirometry;Lung volume;Gas diffusionCriteria:
Inclusion Criteria:
- 18 years or older
- Covid-19 infection with severe disease defined within the last 12 months (defined as
one or more of the following: hospitalization, need for oxygen supply, need for
intensive care treatment, need for specific treatment of Covid disease, antibiotic
treatment)
- Subjective presence of residual symptoms of Covid disease OR no residual symptoms of
Covid disease (Controls)
- Informed consent
Exclusion Criteria:
- Continuous probiotic treatment in the last 4 weeks before inclusion
- Pre-existing lung diseases
15.
ClinicalTrials.gov; 12/01/2021; TrialID: NCT04709302
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04709302
ABSTRACT
Condition:
Covid19;Hiv;ARTIntervention:
Biological: COVID-19;Biological: HIV;Drug: ARTPrimary outcome:
Number of patients developing Acute Respiratory Distress Syndrome;Number of ICU admissions;Number of DeathsCriteria:
Inclusion criteria:
- PLHIV without antiretroviral therapy but with COVID-19 infection
- PLHIV with antiretroviral therapy and COVID-19 infection
- HIV-negative patients, sex- and age matched, infected with COVID-19;
- older than 18 years
Exclusion criteria:
- Those with known co-infections such as hepatitis B and C
- with a viral load of HIV RNA >1000 copies/ml under ART or with advanced symptoms of
AIDS
- negative for SARS-CoV-2 RNA
16.
ClinicalTrials.gov; 04/06/2020; TrialID: NCT04420676
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04420676
ABSTRACT
Condition:
COVIDIntervention:
Dietary Supplement: Omnibiotic AAD;Dietary Supplement: PlaceboPrimary outcome:
Stool calprotectinCriteria:
Inclusion criteria
- 18 years or older
- Covid-19 infection diagnosed by a positive SARS-Cov-2 PCR (Polymerase chain reaction)
result from a nasopharyngeal swab
- Informed (tele)consent Exclusion criteria
- Pre-existing diarrhoea (including but not restricted to chronic inflammatory bowel
disease, chronic diarrhea of other causes, acute diarrheal illness -4 to -1 week
before inclusion)
- Antibiotic therapy -4 to -1 week before inclusion
- Probiotic treatment -4 to -1 week before inclusion
- Technical difficulties to perform telemedicine study visits
17.
ClinicalTrials.gov; 04/06/2020; TrialID: NCT04420637
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04420637
ABSTRACT
Condition:
COVIDPrimary outcome:
liver diseaseCriteria:
Covid-19 infection treated within the KAGES (Steirische Krankenanstalten GesmBH = Styrian
public hospitals)
18.
ClinicalTrials.gov; 14/05/2020; TrialID: NCT04410835
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04410835
ABSTRACT
Condition:
Corona Virus Infection;Psychiatric Disorder;Psychological DistressIntervention:
Diagnostic Test: Online SurveyPrimary outcome:
Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index);Depressive symptoms;Sleep disorders and Sleep QualityCriteria:
Inclusion Criteria:
- Minimum age 18 years
- voluntary participation
Exclusion Criteria:
- Subject refuses to participate
19.
ClinicalTrials.gov; 21/04/2020; TrialID: NCT04359121
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04359121
ABSTRACT
Condition:
COVID19Intervention:
Other: Questionnaires for specific phobiaPrimary outcome:
Development of phobiasCriteria:
Inclusion Criteria:
- Person gives written consent
- Persons between 18-90 years of age (men and women)
- No positive COVID infection known at time of first examination
Exclusion Criteria:
- Dementia, Delirium (not able to give consent)
- Not fulfilling the inclusion criteria
- COVID infection known at first examination point
20.
ClinicalTrials.gov; 10/04/2020; TrialID: NCT04349982
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04349982
ABSTRACT
Condition:
Risk Factor, Cardiovascular;Covid19;Critical Illness;Course IllnessIntervention:
Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)Primary outcome:
ICU CV risk and Biomarker (e.g. Troponin)Criteria:
Inclusion Criteria:
- Admission on an isolation unit - intensive care unit of the LKH Univ. Klinikum Graz
- Detection of a SARS - CoV-2 infection by PCR (tracheal or pharyngeal secretion) or CT
examination (with subsequent PCR detection)
- male and female sex
- subordinated declaration of consent if possible if applicable
- respiratory insufficiency with indication for non-invasive or invasive ventilation
Exclusion Criteria:
- if the inclusion criteria are not met