Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000013864
Ethics application status
Approved
Date submitted
30/12/2020
Date registered
12/01/2021
Date last updated
12/01/2021
Date data sharing statement initially provided
12/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Incidence of COVID-19 disease and the severity of SARS-CoV-2 infection and relationship with angiotensin II type 1 receptor (ATII-1R) concentration in healthcare professionals.
Scientific title
Evaluation of angiotensin II type 1 receptor (ATII-1R) concentration and correlation with incidence and severity of Coronavirus Disease 2019 (COVID-19) among physicians and nurses.
Secondary ID [1] 303085 0
None
Universal Trial Number (UTN)
U1111-1261-6241
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 320165 0
Respiratory function 320167 0
Condition category
Condition code
Infection 318105 318105 0 0
Other infectious diseases
Respiratory 318107 318107 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The cross-sectional observation study will be carried out on physicians and nurses (n=80) from the Wroclaw hospitals (Poland). The study has a voluntary charter and requires informed and written consent to participate.

Two study groups will be identified. The first group (n=40) will include health care providers (physicians and nurses), who have so far had a negative result test of the real-time polymerase chain reaction (rt-PCR) for SARS-CoV-2 (control group). The second group (n=40) will include physicians and nurses who have undergone a COVID-19 infection with a confirmed rt-PCR test for SARS-CoV-2.

On the day of the examination, 1 sample of blood (2.7 ml) will be taken to determine the ATII-1R concentration. After collection, blood samples will be left at room temperature to form a clot (about 30 minutes). They will then be centrifuged for 10 min with 3000 rpm. The resulting sera will be frozen and stored at -700C until the determination is performed.

Demographic data, BMI, blood group, ATII-1R concentration will be analyzed. Additionally, information on chronic diseases (diabetes, hypertension, nicotinism, kidney failure) and medications will be collected. The results will be analyzed statistically.

In the group of "recoveries", the symptoms of SARS-CoV-2 infection and the severity of COVID-19 will be additionally evaluated according to the illness categories described in Clinical Presentation of People with SARS-CoV-2 Infection based on the COVID-19 Treatment Guidelines developed by the National Institutes of Health (NIH):
1. Asymptomatic or Presymptomatic Infection: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test or an antigen test) but who have no symptoms that are consistent with COVID-19.
2. Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
3. Moderate Illness: Individuals who show lower respiratory disease evidence during clinical assessment or imaging and who have a saturation of oxygen (SpO2) equal to 94% on room air at sea level.
4. Severe Illness: Individuals who have SpO2 less than 94% on room air at sea level, a ratio of the arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) less than 300 mmHg, respiratory frequency more than 30 breaths per minute or lung infiltrates more than 50%.
5. Critical Illness: Individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction

The approximate duration of the cross-sectional assessment would be 60-90 minutes.
Intervention code [1] 319381 0
Diagnosis / Prognosis
Intervention code [2] 319382 0
Early Detection / Screening
Comparator / control treatment
Medical personnel (n=40) with negative rt-PCR test results for SARS-CoV-2
Control group
Active

Outcomes
Primary outcome [1] 326094 0
Determination of ATII-1R from blood serum of medical personnel (physicians and nurses) with laboratory tests
Timepoint [1] 326094 0
Baseline (once)
Secondary outcome [1] 390104 0
Assessment of COVID-19 incidence among medical personnel (physicians and nurses) with statistical tests. COVID-19 will be assessed using the nasopharyngeal swab.
Timepoint [1] 390104 0
Baseline (once)
Secondary outcome [2] 390105 0
Assessment of the severity of COVID-19 among medical personnel (physicians and nurses) with clinical categories using the COVID-19 Treatment Guidelines developed by the National Institutes of Health (NIH) based on medical records and documentation.
Timepoint [2] 390105 0
Baseline (once)

Eligibility
Key inclusion criteria
Study group:
1. Age > 18 years old and < 75 years old
2. Physicians and nurses working with COVID-19 patients
3. Personnel with positive rt-PCR test result for SARS-CoV-2
4. The lack of severe systemic diseases precluding participation in the study
5. The obtained informed and written consent to participate in the study.

Control group:
1. Age > 18 years old and < 75 years old
2. Physicians and nurses working with COVID-19 patients
3. Personnel with negative rt-PCR test result for SARS-CoV-2
4. The lack of serious systemic diseases precluding participation in the study
5. The obtained informed and written consent to participate in the study
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Continuously distributed data will be tested for normality using the Shapiro-Wilk and Kolmogorov-Smirnov tests. The critical significance level was assumed at p<0.05. The significance of the differences in the mean values between two groups (e.g., baseline level – 2h level) for the parameters of normal distribution and homogeneous variances will be checked with the t-Student test for the related variables. The significance of differences in average values (medians) between two groups for parameters with a distribution considerably deviating from the theoretical normal distribution or heterogeneous variances will be verified with the Wilcoxon test. The hypotheses about the absence of differences in mean values in more than two groups will be verified using variance analysis (ANOVA). The hypotheses about the absence of differences in average values (medians) in more than two groups were verified using the Kruskal-Wallis and Friedman tests. A receiver operating characteristic (ROC) curve analysis will be performed to calculate the area under the ROC curve. The best cut-off values will be calculated to maximize the sum of sensitivity and specificity. The positive predictive value (PPV), negative predictive value (NPV), and accuracy will also be calculated. The results will be considered statistically significant when the p-values were lower than 0.05. Analyses will be performed using Statistica v.10 (StatSoft, Inc, Tulsa, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 23351 0
Poland
State/province [1] 23351 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 307487 0
Hospital
Name [1] 307487 0
4th Military Hospital of Wroclaw, Department of Anesthesiology and Intensive Care
Country [1] 307487 0
Poland
Primary sponsor type
Individual
Name
Patrycja Lesnik, MD, PhD
Address
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country
Poland
Secondary sponsor category [1] 308166 0
Individual
Name [1] 308166 0
Jaroslaw Janc, MD, PhD
Address [1] 308166 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country [1] 308166 0
Poland
Other collaborator category [1] 281576 0
Individual
Name [1] 281576 0
Lidia Lysenko, MD, PhD
Address [1] 281576 0
Department of Anaesthesiology and Intensive Therapy, Wroclaw Medical University, Borowska 213, 50-529 Wroclaw, Poland
Country [1] 281576 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307562 0
Bioethics Committee of the Wroclaw Medical University
Ethics committee address [1] 307562 0
Ethics committee country [1] 307562 0
Poland
Date submitted for ethics approval [1] 307562 0
01/12/2020
Approval date [1] 307562 0
17/12/2020
Ethics approval number [1] 307562 0
KB–815/2020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107682 0
Dr Patrycja Lesnik, MD, PhD
Address 107682 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 107682 0
Poland
Phone 107682 0
+48 691 840 822
Fax 107682 0
Email 107682 0
[email protected]
Contact person for public queries
Name 107683 0
Patrycja Lesnik, MD, PhD
Address 107683 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 107683 0
Poland
Phone 107683 0
+48 691 840 822
Fax 107683 0
Email 107683 0
[email protected]
Contact person for scientific queries
Name 107684 0
Patrycja Lesnik, MD, PhD
Address 107684 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 107684 0
Poland
Phone 107684 0
+48 691 840 822
Fax 107684 0
Email 107684 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only to researchers who provide a methodologically relevant explanation

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Only to achieve the purposes of the approved request

When can requests for individual participant data be made (start and end dates)?
From:
Immediately the following publication on reasonable request (available for 5 years after publication)

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• The data can be obtained by emailing the principal investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10137Ethical approval    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes the Serum Concentration of Angiotensin II Type 1 Receptor Have an Effect on the Severity of COVID-19? A Prospective Preliminary Observational Study among Healthcare Professionals.2022https://dx.doi.org/10.3390/jcm11071769
N.B. These documents automatically identified may not have been verified by the study sponsor.