Coronavirus Disease 2019COVID-19NCT04388631

Detection Rate of SARS-CoV-2 in Male Genitourinary System and Its Impact on Male Reproductive Health.

An observational study of Coronavirus Disease 2019, run by Tongji Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Coronavirus Disease 2019
What is being tested?: Coronavirus Disease 2019
How many people: 200 participants
Where: 1 siteChina
Study dates: 10 May 2020to 1 May 2021
How long will I take part?: 12 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 60 years
Men only
Healthy volunteers accepted
Adult

Study population: male patients discharged with COVID-19 who have no previous sexual function and fertility related disease.

Who may be able to join

Age≥ 18, ≤ 60 years old;
Have a fixed sex partner and regular sex life;
No previous infectious diseases, chronic diseases, tumor history, and male sexual function and fertility diseases;
Normal erectile function, IIEF-5 score> 21 points;
Have complete clinical information and contact information；
Understand and sign the informed consent form.

Who cannot join

Hypertension, diabetes, coronary heart disease, hyperlipidemia and other chronic diseases；
Past history of endocrine diseases such as hypopituitarism, hypogonadism, abnormal thyroid function, etc;
Past history of mumps virus infection;
Past history of bladder cancer, prostate cancer, brain spine injury, testicular injury, pelvic fracture, urethral injury and history of surgical treatment;
Severe cardiovascular and cerebrovascular diseases, severe lung diseases, severe hepatitis;
Past psychological or mental illness;
Contact information not available.

Trial locations and contacts

1 site in 1 country.

Tao Wang, M.D contact

027-83663640

tjhwt@126.com

China1 site, 1 recruiting

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Tao Wang, M.D, tjhwt@126.com
Jihong Liu
Recruiting

Other trials in China

About this study

Official title: Detection Rate of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Male Genitourinary System and Its Impact on Male Reproductive Health: an Observational Clinical Study.

This study will evaluate the changes in sexual function, reproductive function and mental health of male patients discharged from the hospital with COVID-19, and the impact of SARS-CoV-2 on male reproductive health and mental health compared with healthy people during the same period. In addition, men's semen examination reports before and after the new coronavirus pneumonia event will be collected and compared to assess the impact of the event on the quality of men's semen. Also, This study will test the SARS-CoV-2 nucleic acid of the urogenital system of male patients discharged with COVID-19 to provide evidence for the effect of the new coronavirus on the male reproductive system.

Read the detailed description

This study will test SARS-CoV-2 nucleic acids in urine, prostate fluid, and semen of participants with COVID-19 at the first follow-up. All participants will be followed up for 1 year. During follow-up, International Index of Erectile Function-5 (IIEF-5), Quality Evaluation Questionnaire (QEQ), symptom list chart-90 (SCL-90) questionnaire evaluation and sexual function related examinations (including nocturnal penile tumescence, color duplex ultrasonography, etc. ) and fertility-related examinations (including sex hormones, semen routine examinations, etc.) will be performed to assess the changes in male sexual function, reproductive function and mental health of male patients discharged with COVID-19, and the impact of SARS-CoV-2 on male reproductive and mental health. In addition, collect male semen examination reports from April to December in 2017-2020 to evaluate the impact of new coronavirus pneumonia incidents on male semen quality.

Conditions: Coronavirus Disease 2019
Being tested: Coronavirus Disease 2019
Keywords: Coronavirus Disease 2019, Male reproductive health, Mental health
Medical subject headings: COVID-19, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coronavirus Disease 2019Other
male patients who have developed COVID-19

Study groups in NCT04388631
Study group	Role	What they receive
Exposed group		Male patient discharged with COVID-19 Receives: Other: Coronavirus Disease 2019
Control group		Healthy male volunteers without COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

Sperm density
Sperm density will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Measured: 3 months
Sperm activity
Sperm activity will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Measured: 3 months
Erection hardness and duration
Erection hardness and duration will be evaluated during sleep by RigiscanHealth Organization (WHO) normal values based on the WHO 2010 reference limits.
Measured: 3 months
IIEF-5/QEQ questionnaire score
IIEF-5/QEQ questionnaire score will be obtained by filling out the questionnaire every visit.
Measured: 3 months
Detection rate of SARS-CoV-2 in male genitourinary system
Detection rate of SARS-CoV-2 in male genitourinary system will be evaluated by real time-polymerase chain reaction (RT-PCR).
Measured: 1 month

Secondary outcomes (4)

Semen volume
Sperm volume will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Measured: 3 months
Sperm survival rate
Sperm survival rate will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Measured: 3 months
Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level
The serum testosterone/LH/FSH levels will be tested in every visit.
Measured: 3 months
SCL-90 questionnaire score
SCL-90 questionnaire score will be obtained using SCL-90 questionnaire.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 20201 May 2021

First posted14 May 2020
Study start10 May 2020 (estimated)
Primary completion1 May 2021 (estimated)
Study completion1 May 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
More trials run by Tongji HospitalThe 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: 200 participants (estimated)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04388631
Sponsor's protocol ID: 2020-S073
Acronym: COVID-19
Status last verified: May 2020
First submitted: 12 May 2020
Last updated: 18 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data for all primary and secondary outcome measure will be available.

Publications

Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
PubMed 32142651
Douglas GC, O'Bryan MK, Hedger MP, Lee DK, Yarski MA, Smith AI, Lew RA. The novel angiotensin-converting enzyme (ACE) homolog, ACE2, is selectively expressed by adult Leydig cells of the testis. Endocrinology. 2004 Oct;145(10):4703-11. doi: 10.1210/en.2004-0443. Epub 2004 Jul 1.
PubMed 15231706
Xu J, Qi L, Chi X, Yang J, Wei X, Gong E, Peh S, Gu J. Orchitis: a complication of severe acute respiratory syndrome (SARS). Biol Reprod. 2006 Feb;74(2):410-6. doi: 10.1095/biolreprod.105.044776. Epub 2005 Oct 19.
PubMed 16237152
Fraga-Silva RA, Costa-Fraga FP, Montecucco F, Sturny M, Faye Y, Mach F, Pelli G, Shenoy V, da Silva RF, Raizada MK, Santos RA, Stergiopulos N. Diminazene protects corpus cavernosum against hypercholesterolemia-induced injury. J Sex Med. 2015 Feb;12(2):289-302. doi: 10.1111/jsm.12757. Epub 2014 Nov 20.
PubMed 25411084

Want to know more?

Tao Wang, M.D

027-83663640

tjhwt@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Detection Rate of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Male Genitourinary System and Its Impact on Male Reproductive Health: an Observational Clinical Study.
ClinicalTrials.gov ID: NCT04388631
Acronym / sponsor ID: COVID-19 / 2020-S073
Conditions: Coronavirus Disease 2019
Keywords: Coronavirus Disease 2019, Male reproductive health, Mental health
Study type: Observational
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: Tongji HospitalUniversity, hospital or other
Study start: 10 May 2020 (estimated)
Primary completion: 1 May 2021 (estimated)
Study completion: 1 May 2021 (estimated)
First posted: 14 May 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 2

Arm	Type	Receives
Exposed group	–	Other: Coronavirus Disease 2019Male patient discharged with COVID-19
Control group	–	–Healthy male volunteers without COVID-19

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult
Study population: male patients discharged with COVID-19 who have no previous sexual function and fertility related disease.

Key inclusion criteria (6 listed)

Age≥ 18, ≤ 60 years old;
Have a fixed sex partner and regular sex life;
No previous infectious diseases, chronic diseases, tumor history, and male sexual function and fertility diseases;
Normal erectile function, IIEF-5 score> 21 points;
Have complete clinical information and contact information；

Key exclusion criteria (7 listed)

Hypertension, diabetes, coronary heart disease, hyperlipidemia and other chronic diseases；
Past history of endocrine diseases such as hypopituitarism, hypogonadism, abnormal thyroid function, etc;
Past history of mumps virus infection;
Past history of bladder cancer, prostate cancer, brain spine injury, testicular injury, pelvic fracture, urethral injury and history of surgical treatment;
Severe cardiovascular and cerebrovascular diseases, severe lung diseases, severe hepatitis;

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
Coronavirus Disease 2019male patients who have developed COVID-19	Other	Exposed group

Primary outcome

Sperm density
Time frame: 3 months
Sperm density will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Sperm activity
Time frame: 3 months
Sperm activity will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Erection hardness and duration
Time frame: 3 months
Erection hardness and duration will be evaluated during sleep by RigiscanHealth Organization (WHO) normal values based on the WHO 2010 reference limits.
IIEF-5/QEQ questionnaire score
Time frame: 3 months
IIEF-5/QEQ questionnaire score will be obtained by filling out the questionnaire every visit.
Detection rate of SARS-CoV-2 in male genitourinary system
Time frame: 1 month
Detection rate of SARS-CoV-2 in male genitourinary system will be evaluated by real time-polymerase chain reaction (RT-PCR).

4 secondary outcomes

Semen volume
Time frame: 3 months
Sperm survival rate
Time frame: 3 months
Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level
Time frame: 3 months
SCL-90 questionnaire score
Time frame: 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
Background: PubMed 32142651Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
Background: PubMed 15231706Douglas GC, O'Bryan MK, Hedger MP, Lee DK, Yarski MA, Smith AI, Lew RA. The novel angiotensin-converting enzyme (ACE) homolog, ACE2, is selectively expressed by adult Leydig cells of the testis. Endocrinology. 2004 Oct;145(10):4703-11. doi: 10.1210/en.2004-0443. Epub 2004 Jul 1.
Background: PubMed 16237152Xu J, Qi L, Chi X, Yang J, Wei X, Gong E, Peh S, Gu J. Orchitis: a complication of severe acute respiratory syndrome (SARS). Biol Reprod. 2006 Feb;74(2):410-6. doi: 10.1095/biolreprod.105.044776. Epub 2005 Oct 19.
Background: PubMed 25411084Fraga-Silva RA, Costa-Fraga FP, Montecucco F, Sturny M, Faye Y, Mach F, Pelli G, Shenoy V, da Silva RF, Raizada MK, Santos RA, Stergiopulos N. Diminazene protects corpus cavernosum against hypercholesterolemia-induced injury. J Sex Med. 2015 Feb;12(2):289-302. doi: 10.1111/jsm.12757. Epub 2014 Nov 20.
Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measure will be available.

Related trials for Coronavirus Disease 2019

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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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.

Tao Wang, M.D contact

027-83663640

tjhwt@126.com

Jihong Liu, M.D principal investigator

Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

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 Coronavirus Disease 2019, run by Tongji Hospital at 1 site in China.

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 6 inclusion and 7 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 18 May 2020. 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 China. 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?

Contact Tao Wang, M.D (027-83663640, tjhwt@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sperm density (time frame: 3 months). The study lists 5 primary outcomes in all. 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 NCT04388631, which also lists 4 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 18 May 2020.