COVID-19 Acute Respiratory Distress SyndromeNCT05318144
Melatonin Levels on COVID-19 Positive Pregnant Women
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Pregnancy Related, run by Nazan Yurtcu MD at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the prognostic value of serum melatonin as a biomarker for the determination of severe COVID-19 infection in pregnant women. Four study groups were formed, including pregnant women with a positive COVID-19 PCR test, severe symptoms, and inpatient treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Pregnancy Related, Pregnancy Complications
- How many people
- 228 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Feb 2022
- How long will I take part?
- 6 Months
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with COVID-19 and control groups
Who may be able to join
- pregnant women with a positive COVID-19 PCR test and severe symptoms and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints but had a PCR test due to the surveillance program and negative test results were included in the control group. Pregnant women who had contact with people with COVID-19 infection and had a PCR test due to the surveillance program and had positive results, but no complaints were included in the other study group. The PCR test of pregnant women who had complaints and needed inpatient treatment during the COVID-19 infection was confirmed, and the COVID-19 infection was graded according to WHO's criteria. Pregnant women with viral infection with symptoms compatible with infection and virus isolation in any culture samples collected at admission were included in the patient group with PCR positive mild-moderate and severe COVID-19 infection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Training and Research Hospital
Samsun, 58153
About this study
Official title: Prognostic Value of Serum Melatonin as a Biomarker for the Determination of Severe COVID-19 Infection in Pregnant Women
This study aimed to investigate the prognostic value of serum melatonin as a biomarker for the determination of severe COVID-19 infection in pregnant women.
Four study groups were formed, including pregnant women with a positive COVID-19 PCR test, severe symptoms, and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints, but had a PCR test due to the surveillance program and negative test results were included in the control group.
Read more
Methods and Main Outcome measure: Laboratory values of the cases at the time of diagnosis parameters were collected.
Melatonin levels decrease in pregnant women with COVID-19 symptoms, the severity of symptoms increases. In addition, patients with low melatonin levels have an increase in infection parameters and an increase in the hospital stay.
Read the detailed description
A total of 228 pregnant women included in this prospective controlled study between June 20021 and June 2022 at Gynecology and Obstetrics Department of Health Sciences University Samsun Training and Research Hospital.
- Keywords
- COVID-19, SARS-CoV-2, Melatonine, pregnancy, pregnancy outcomes
- Medical subject headings
- Pregnancy Complications, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| PCR (-) symptomatic | control group, pregnant women with negative COVID-19 Polymerase Chain Reaction (PCR) test | |
| PCR (+) asymptomatic | Pregnant women who have a positive COVID-19 PCR test and have had the infection without symptoms | |
| PCR (+) mild-moderate | Pregnant women with positive COVID-19 PCR test and mild to moderate symptoms and inpatient treatment | |
| PCR (+) severe COVID-19 | Pregnant women with positive COVID-19 PCR test and severe symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin level
Melatonin level of pregnant women with COVID-19
Measured: 6 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Jun 2021
- Primary completion1 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nazan Yurtcu MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazan Yurtcu MD, Cumhuriyet University
- Investigators
- Serkan Oral, Study chair, Halic University Faculty of Medicine, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318144
- Sponsor's protocol ID
- COVID-19 and pregnancy
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: June 2021- December 2021
Publications
Di Mascio D, Buca D, Berghella V, Khalil A, Rizzo G, Odibo A, Saccone G, Galindo A, Liberati M, D'Antonio F. Counseling in maternal-fetal medicine: SARS-CoV-2 infection in pregnancy. Ultrasound Obstet Gynecol. 2021 May;57(5):687-697. doi: 10.1002/uog.23628.
PubMed 33724545Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076Huntley BJF, Huntley ES, Di Mascio D, Chen T, Berghella V, Chauhan SP. Rates of Maternal and Perinatal Mortality and Vertical Transmission in Pregnancies Complicated by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Co-V-2) Infection: A Systematic Review. Obstet Gynecol. 2020 Aug;136(2):303-312. doi: 10.1097/AOG.0000000000004010.
PubMed 32516273Yurtcu N, Caliskan C, Celik S. Serum Melatonin as a Biomarker for Assessment of Late-term and Postterm Pregnancies in Women without Spontaneous Onset of Labor. Z Geburtshilfe Neonatol. 2021 Dec;225(6):499-505. doi: 10.1055/a-1479-3220. Epub 2021 May 31.
PubMed 34058776Head Zauche L, Wallace B, Smoots AN, Olson CK, Oduyebo T, Kim SY, Peterson EE, Ju J, Beauregard J, Wilcox AJ, Rose CE, Meaney-Delman D, Ellington SR. Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21. Res Sq [Preprint]. 2021 Aug 9:rs.3.rs-798175. doi: 10.21203/rs.3.rs-798175/v1.
PubMed 34401872Wastnedge EAN, Reynolds RM, van Boeckel SR, Stock SJ, Denison FC, Maybin JA, Critchley HOD. Pregnancy and COVID-19. Physiol Rev. 2021 Jan 1;101(1):303-318. doi: 10.1152/physrev.00024.2020. Epub 2020 Sep 24.
PubMed 32969772Wong SF, Chow KM, Leung TN, Ng WF, Ng TK, Shek CC, Ng PC, Lam PW, Ho LC, To WW, Lai ST, Yan WW, Tan PY. Pregnancy and perinatal outcomes of women with severe acute respiratory syndrome. Am J Obstet Gynecol. 2004 Jul;191(1):292-7. doi: 10.1016/j.ajog.2003.11.019.
PubMed 15295381Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, Vecchiet J, Nappi L, Scambia G, Berghella V, D'Antonio F. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 May;2(2):100107. doi: 10.1016/j.ajogmf.2020.100107. Epub 2020 Mar 25.
PubMed 32292902Voiculescu SE, Zygouropoulos N, Zahiu CD, Zagrean AM. Role of melatonin in embryo fetal development. J Med Life. 2014 Oct-Dec;7(4):488-92.
PubMed 25713608Uzun M, Gencer M, Turkon H, Oztopuz RO, Demir U, Ovali MA. Effects of Melatonin on Blood Pressure, Oxidative Stress and Placental Expressions of TNFalpha, IL-6, VEGF and sFlt-1 in RUPP Rat Model of Preeclampsia. Arch Med Res. 2017 Oct;48(7):592-598. doi: 10.1016/j.arcmed.2017.08.007. Epub 2018 Feb 1. No abstract available.
PubMed 29397206Anderson G, Maes M, Markus RP, Rodriguez M. Ebola virus: melatonin as a readily available treatment option. J Med Virol. 2015 Apr;87(4):537-43. doi: 10.1002/jmv.24130. Epub 2015 Jan 21.
PubMed 25611054Anderson G, Reiter RJ. Melatonin: Roles in influenza, Covid-19, and other viral infections. Rev Med Virol. 2020 May;30(3):e2109. doi: 10.1002/rmv.2109. Epub 2020 Apr 21.
PubMed 32314850Nehme PA, Amaral FG, Middleton B, Lowden A, Marqueze E, Franca-Junior I, Antunes JLF, Cipolla-Neto J, Skene DJ, Moreno CRC. Melatonin profiles during the third trimester of pregnancy and health status in the offspring among day and night workers: A case series. Neurobiol Sleep Circadian Rhythms. 2019 Apr 13;6:70-76. doi: 10.1016/j.nbscr.2019.04.001. eCollection 2019 Jan.
PubMed 31236522Farnoosh G, Akbariqomi M, Badri T, Bagheri M, Izadi M, Saeedi-Boroujeni A, Rezaie E, Ghaleh HEG, Aghamollaei H, Fasihi-Ramandi M, Hassanpour K, Alishiri G. Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical Trial. Arch Med Res. 2022 Jan;53(1):79-85. doi: 10.1016/j.arcmed.2021.06.006. Epub 2021 Jun 23.
PubMed 34229896Salles C. Correspondence COVID-19: Melatonin as a potential adjuvant treatment. Life Sci. 2020 Jul 15;253:117716. doi: 10.1016/j.lfs.2020.117716. Epub 2020 Apr 22. No abstract available.
PubMed 32334009
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Serum Melatonin as a Biomarker for the Determination of Severe COVID-19 Infection in Pregnant Women
- ClinicalTrials.gov ID
- NCT05318144
- Acronym / sponsor ID
- COVID-19 and pregnancy
- Keywords
- COVID-19, SARS-CoV-2, Melatonine, pregnancy, pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Nazan Yurtcu MDUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 8 Apr 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.
This study aimed to investigate the prognostic value of serum melatonin as a biomarker for the determination of severe COVID-19 infection in pregnant women.
Four study groups were formed, including pregnant women with a positive COVID-19 PCR test, severe symptoms, and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints, but had a PCR test due to the surveillance program and negative test results were included in the control group.
Methods and Main Outcome measure: Laboratory values of the cases at the time of diagnosis parameters were collected.
Melatonin levels decrease in pregnant women with COVID-19 symptoms, the severity of symptoms increases. In addition, patients with low melatonin levels have an increase in infection parameters and an increase in the hospital stay.
Detailed description
A total of 228 pregnant women included in this prospective controlled study between June 20021 and June 2022 at Gynecology and Obstetrics Department of Health Sciences University Samsun Training and Research Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PCR (-) symptomatic | – | –control group, pregnant women with negative COVID-19 Polymerase Chain Reaction (PCR) test |
| PCR (+) asymptomatic | – | –Pregnant women who have a positive COVID-19 PCR test and have had the infection without symptoms |
| PCR (+) mild-moderate | – | –Pregnant women with positive COVID-19 PCR test and mild to moderate symptoms and inpatient treatment |
| PCR (+) severe COVID-19 | – | –Pregnant women with positive COVID-19 PCR test and severe symptoms |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with COVID-19 and control groups
Key inclusion criteria (1 listed)
- pregnant women with a positive COVID-19 PCR test and severe symptoms and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints but had a PCR test due to the surveillance program and negative test results were included in the control group. Pregnant women who had contact with people with COVID-19 infection and had a PCR test due to the surveillance program and had positive results, but no complaints were included in the other study group. The PCR test of pregnant women who had complaints and needed inpatient treatment during the COVID-19 infection was confirmed, and the COVID-19 infection was graded according to WHO's criteria. Pregnant women with viral infection with symptoms compatible with infection and virus isolation in any culture samples collected at admission were included in the patient group with PCR positive mild-moderate and severe COVID-19 infection.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Other | PCR (+) asymptomatic, PCR (+) mild-moderate, PCR (+) severe COVID-19, PCR (-) symptomatic |
Primary outcome
Melatonin level
Time frame: 6 year
Melatonin level of pregnant women with COVID-19
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 8 Apr 2022.
- Background: PubMed 33724545Di Mascio D, Buca D, Berghella V, Khalil A, Rizzo G, Odibo A, Saccone G, Galindo A, Liberati M, D'Antonio F. Counseling in maternal-fetal medicine: SARS-CoV-2 infection in pregnancy. Ultrasound Obstet Gynecol. 2021 May;57(5):687-697. doi: 10.1002/uog.23628.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 32516273Huntley BJF, Huntley ES, Di Mascio D, Chen T, Berghella V, Chauhan SP. Rates of Maternal and Perinatal Mortality and Vertical Transmission in Pregnancies Complicated by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Co-V-2) Infection: A Systematic Review. Obstet Gynecol. 2020 Aug;136(2):303-312. doi: 10.1097/AOG.0000000000004010.
- Results publication: PubMed 34058776Yurtcu N, Caliskan C, Celik S. Serum Melatonin as a Biomarker for Assessment of Late-term and Postterm Pregnancies in Women without Spontaneous Onset of Labor. Z Geburtshilfe Neonatol. 2021 Dec;225(6):499-505. doi: 10.1055/a-1479-3220. Epub 2021 May 31.
- Results publication: PubMed 34401872Head Zauche L, Wallace B, Smoots AN, Olson CK, Oduyebo T, Kim SY, Peterson EE, Ju J, Beauregard J, Wilcox AJ, Rose CE, Meaney-Delman D, Ellington SR. Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21. Res Sq [Preprint]. 2021 Aug 9:rs.3.rs-798175. doi: 10.21203/rs.3.rs-798175/v1.
- Results publication: PubMed 32969772Wastnedge EAN, Reynolds RM, van Boeckel SR, Stock SJ, Denison FC, Maybin JA, Critchley HOD. Pregnancy and COVID-19. Physiol Rev. 2021 Jan 1;101(1):303-318. doi: 10.1152/physrev.00024.2020. Epub 2020 Sep 24.
- Results publication: PubMed 15295381Wong SF, Chow KM, Leung TN, Ng WF, Ng TK, Shek CC, Ng PC, Lam PW, Ho LC, To WW, Lai ST, Yan WW, Tan PY. Pregnancy and perinatal outcomes of women with severe acute respiratory syndrome. Am J Obstet Gynecol. 2004 Jul;191(1):292-7. doi: 10.1016/j.ajog.2003.11.019.
- Results publication: PubMed 32292902Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, Vecchiet J, Nappi L, Scambia G, Berghella V, D'Antonio F. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 May;2(2):100107. doi: 10.1016/j.ajogmf.2020.100107. Epub 2020 Mar 25.
- Results publication: PubMed 25713608Voiculescu SE, Zygouropoulos N, Zahiu CD, Zagrean AM. Role of melatonin in embryo fetal development. J Med Life. 2014 Oct-Dec;7(4):488-92.
- Results publication: PubMed 29397206Uzun M, Gencer M, Turkon H, Oztopuz RO, Demir U, Ovali MA. Effects of Melatonin on Blood Pressure, Oxidative Stress and Placental Expressions of TNFalpha, IL-6, VEGF and sFlt-1 in RUPP Rat Model of Preeclampsia. Arch Med Res. 2017 Oct;48(7):592-598. doi: 10.1016/j.arcmed.2017.08.007. Epub 2018 Feb 1. No abstract available.
- Results publication: PubMed 25611054Anderson G, Maes M, Markus RP, Rodriguez M. Ebola virus: melatonin as a readily available treatment option. J Med Virol. 2015 Apr;87(4):537-43. doi: 10.1002/jmv.24130. Epub 2015 Jan 21.
- Results publication: PubMed 32314850Anderson G, Reiter RJ. Melatonin: Roles in influenza, Covid-19, and other viral infections. Rev Med Virol. 2020 May;30(3):e2109. doi: 10.1002/rmv.2109. Epub 2020 Apr 21.
- Individual participant dataSharing planned: No. June 2021- December 2021
Related trials for COVID-19 Acute Respiratory Distress Syndrome
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingPhase 1/2
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome
Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
RecruitingPhase 1/2
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)
Systemic Inflammatory Response Syndrome
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.
Serkan Oral study chair
Halic University Faculty of Medicine, Department of Obstetrics and Gynecology
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-19 Acute Respiratory Distress Syndrome and Pregnancy Related, run by Nazan Yurtcu MD 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 1 inclusion and 0 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 8 Apr 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?
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?
Melatonin level (time frame: 6 year). 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 NCT05318144, which also lists 16 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 8 Apr 2022.