Corona Virus InfectionNCT05242172
THE RELATIONSHIP OF CRP/ALBUMIN RATIO LEVEL AND PROGNOSIS IN PREGNANT COVID-19 PATIENTS
An observational study of Corona Virus Infection and Pregnancy; Infection, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Corona Virus Infection, Pregnancy; Infection
- What is being tested?
- CRP/Albumin ratio
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: hospitalised Covid PCR test positive pregnant patient
Who may be able to join
- Covid PCR test positive patients
- Pregnant
Who cannot join
- Covid PCR test negative
- Missed data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adıyaman Training and Research Hospital
Adıyaman, 02200
About this study
The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. With this study it is aimed to investigate the effect of CRP/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe Covid-19 infection.
Read the detailed description
Pregnant women are more susceptible to viral infections affecting the respiratory tract than non-pregnant women. Similar to non-pregnant patients, Covid-19 infection occurs with non-specific symptoms in pregnant patients. A computed tomography (CT) scan of lungs and several laboratory parameters are used to predict the prognosis of this infection, which starts with non-specific findings. Although it has been demonstrated that low-dose lung CT can be used safely in pregnant women, both clinicians and pregnant women tend to avoid tomography imaging due to its teratogenic effects
The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. It is an indicator of both the inflammatory state and the nutritional state, simultaneously. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. With this study it is aimed to investigate the effect of CRP/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe Covid-19 infection.
- Conditions
- Corona Virus Infection, Pregnancy; Infection
- Being tested
- CRP/Albumin ratio
- Medical subject headings
- Coronavirus Infections, Pregnancy Complications, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP/Albumin ratioDiagnostic test
it is aimed to investigate prognosis and severity of covid-19 infection with using CRP/Albumin ratio in pregnant patient
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP/Albumin ratio
Measured: First day of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start15 Jan 2022
- Primary completion15 Feb 2022
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242172
- Sponsor's protocol ID
- 14/12/2021-2021/10-19
- Status last verified
- Jan 2022
- First submitted
- 15 Feb 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE RELATIONSHIP OF CRP/ALBUMIN RATIO LEVEL AND PROGNOSIS IN PREGNANT COVID-19 PATIENTS
- ClinicalTrials.gov ID
- NCT05242172
- Acronym / sponsor ID
- 14/12/2021-2021/10-19
- Conditions
- Corona Virus Infection, Pregnancy; Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. With this study it is aimed to investigate the effect of CRP/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe Covid-19 infection.
Detailed description
Pregnant women are more susceptible to viral infections affecting the respiratory tract than non-pregnant women. Similar to non-pregnant patients, Covid-19 infection occurs with non-specific symptoms in pregnant patients. A computed tomography (CT) scan of lungs and several laboratory parameters are used to predict the prognosis of this infection, which starts with non-specific findings. Although it has been demonstrated that low-dose lung CT can be used safely in pregnant women, both clinicians and pregnant women tend to avoid tomography imaging due to its teratogenic effects
The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. It is an indicator of both the inflammatory state and the nutritional state, simultaneously. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. With this study it is aimed to investigate the effect of CRP/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe Covid-19 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- hospitalised Covid PCR test positive pregnant patient
Key inclusion criteria (2 listed)
- Covid PCR test positive patients
- Pregnant
Key exclusion criteria (2 listed)
- Covid PCR test negative
- Missed data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRP/Albumin ratioit is aimed to investigate prognosis and severity of covid-19 infection with using CRP/Albumin ratio in pregnant patient | Diagnostic test | – |
Primary outcome
CRP/Albumin ratio
Time frame: First day of hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and Pregnancy; Infection, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP/Albumin ratio (time frame: First day of hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.