COVIDNCT04437940
Evaluation of Vaginal Fluid for Covid-19 Positivity in Women With Positive Nasofarengeal Covid-19 Test
An observational study of COVID and Sars-CoV2, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk of transmission of Covid-19 by intercourse or vaginal delivery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- What is being tested?
- Vaginal fluid Covid-19 PCR test
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 30 Nov 2020
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who are older than18 years old, who are considered to be covid-19 clinically and radiologically positive or nasofarengeal Covid-19 PCR test is positive will be included. Patients previously treated for covid-19 will be excluded from the study.
Who may be able to join
- Women who are positive nasofarengeal Covid-19 PCR test result
- Women who are 18 years or older
- Women who had sexual intercourse before
Who cannot join
- who had medical treatment for Covid-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Vaginal Fluid for Covid-19 Positivity
Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk of transmission of Covid-19 by intercourse or vaginal delivery.
Read the detailed description
Vaginal Covid-19 will be tested by taking vaginal swabs from female patients whose clinical findings are compatible with Covid-19 in Acıbadem Maslak Hospital. In patients with positive vaginal Covid-19 test, vaginal Covid-19 will be re-evaluated for the assessment of viral clearance.
- Being tested
- Vaginal fluid Covid-19 PCR test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal fluid Covid-19 PCR testDiagnostic test
Vaginal fluid samples are tested for Covid-19
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 positive women | Women with nasofarangeal Covid-19 PCR test is positive Receives: Diagnostic Test: Vaginal fluid Covid-19 PCR test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal fluid Covid-19 PCR test result
Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive
Measured: 1 month
Secondary outcomes (1)
becoming negative from positive
The ratio of negative test results to previous positive results for vaginal fluid Covid-19 test
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start15 Jun 2020
- Primary completion10 Jul 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozguc Takmaz, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437940
- Sponsor's protocol ID
- Acibadem Maslak Ob&Gyn
- Status last verified
- Jan 2021
- First submitted
- 17 Jun 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data of the patients will be shared without personel informations
Publications
Cui P, Chen Z, Wang T, Dai J, Zhang J, Ding T, Jiang J, Liu J, Zhang C, Shan W, Wang S, Rong Y, Chang J, Miao X, Ma X, Wang S. Severe acute respiratory syndrome coronavirus 2 detection in the female lower genital tract. Am J Obstet Gynecol. 2020 Jul;223(1):131-134. doi: 10.1016/j.ajog.2020.04.038. Epub 2020 May 4. No abstract available.
PubMed 32376320Qiu L, Liu X, Xiao M, Xie J, Cao W, Liu Z, Morse A, Xie Y, Li T, Zhu L. SARS-CoV-2 Is Not Detectable in the Vaginal Fluid of Women With Severe COVID-19 Infection. Clin Infect Dis. 2020 Jul 28;71(15):813-817. doi: 10.1093/cid/ciaa375.
PubMed 32241022
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vaginal Fluid for Covid-19 Positivity
- ClinicalTrials.gov ID
- NCT04437940
- Acronym / sponsor ID
- Acibadem Maslak Ob&Gyn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 18 Jun 2020 (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.
Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk of transmission of Covid-19 by intercourse or vaginal delivery.
Detailed description
Vaginal Covid-19 will be tested by taking vaginal swabs from female patients whose clinical findings are compatible with Covid-19 in Acıbadem Maslak Hospital. In patients with positive vaginal Covid-19 test, vaginal Covid-19 will be re-evaluated for the assessment of viral clearance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 positive women | – | Diagnostic Test: Vaginal fluid Covid-19 PCR testWomen with nasofarangeal Covid-19 PCR test is positive |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are older than18 years old, who are considered to be covid-19 clinically and radiologically positive or nasofarengeal Covid-19 PCR test is positive will be included. Patients previously treated for covid-19 will be excluded from the study.
Key inclusion criteria (3 listed)
- Women who are positive nasofarengeal Covid-19 PCR test result
- Women who are 18 years or older
- Women who had sexual intercourse before
Key exclusion criteria (1 listed)
- who had medical treatment for Covid-19
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 |
|---|---|---|
| Vaginal fluid Covid-19 PCR testVaginal fluid samples are tested for Covid-19 | Diagnostic test | Covid-19 positive women |
Primary outcome
Vaginal fluid Covid-19 PCR test result
Time frame: 1 month
Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive
1 secondary outcome
becoming negative from positive
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 32376320Cui P, Chen Z, Wang T, Dai J, Zhang J, Ding T, Jiang J, Liu J, Zhang C, Shan W, Wang S, Rong Y, Chang J, Miao X, Ma X, Wang S. Severe acute respiratory syndrome coronavirus 2 detection in the female lower genital tract. Am J Obstet Gynecol. 2020 Jul;223(1):131-134. doi: 10.1016/j.ajog.2020.04.038. Epub 2020 May 4. No abstract available.
- Results publication: PubMed 32241022Qiu L, Liu X, Xiao M, Xie J, Cao W, Liu Z, Morse A, Xie Y, Li T, Zhu L. SARS-CoV-2 Is Not Detectable in the Vaginal Fluid of Women With Severe COVID-19 Infection. Clin Infect Dis. 2020 Jul 28;71(15):813-817. doi: 10.1093/cid/ciaa375.
- Individual participant dataSharing planned: Undecided. Data of the patients will be shared without personel informations
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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 COVID and Sars-CoV2, run by Acibadem University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vaginal fluid Covid-19 PCR test result (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437940, which also lists 2 linked publications.
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 12 Jan 2021.