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LOng COvid COmorbidities: Andrological, Reproductive, Sexual Dysfunctions in Patients Recovered From COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05379556
Recruitment Status : Recruiting
First Posted : May 18, 2022
Last Update Posted : May 26, 2022
Sponsor:
Collaborator:
Azienda Sanitaria Locale Napoli 2 Nord
Information provided by (Responsible Party):
Prof. Rosario Pivonello, Federico II University

Brief Summary:
Considering the compelling amount of studies focused on patients in the active phase of COVID-19 disease and the scarcity of studies focused on patient cured from disease aimed at evaluating the sequelae of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, the purpose of the study is to investigate, in patients recovered from COVID-19 disease: 1) whether SARS-CoV-2 infection has induced in male patients, a primary (testicular) and / or secondary (pituitary) damage to the hypothalamic-pituitary-testicular hormonal axis, structural and / or functional damage to the testis and penis, sexual dysfunction or fertility disorders; 2) the prevalence in male and female patients of chemosensory symptoms (olfactory dysfunction) and assess whether there is a correlation between the prevalence, severity, duration and eventual persistence of olfactory dysfunction and the severity of COVID-19 disease. Patients will be evaluated at baseline (at discharge from infectious and/or pneumology unit) and after 3- 12 months. A better definition of the prevalence and type of sequelae after recovery from COVID-19 disease could significantly improve the therapeutic management and long-term follow-up of these patients, with a relevant impact in terms of health resources and public health.

Condition or disease Intervention/treatment
Long Covid-19 Diagnostic Test: Assessment of andrological profile of LO-COCO-ANDRO male patients Diagnostic Test: Assessment of reproductive function of LO-COCO-ANDRO male patients Diagnostic Test: Assessment of sexual function of LO-COCO-ANDRO male patients Diagnostic Test: Assessment of olfactory function of LO-COCO-ANDRO male and female patients

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: LOng COvid COmorbidities: Evaluation of Andrological, Reproductive and Sexual Functions in Patients Recovered From COVID-19
Actual Study Start Date : January 27, 2022
Estimated Primary Completion Date : January 27, 2024
Estimated Study Completion Date : January 27, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Assessment of andrological profile of LO-COCO-ANDRO male patients
    Assessment of serum prolactin (PRL), luteininzing hormone (LH), follicle stimulating hormone (FSH), 17β-estradiol, testosterone. Physical examination with measurement of body weight, height, body mass index, waist and hip circumference. Andrological physical examination with evaluation of testis volume with Prader orchidometer, testicular consistency and lesions, varicocele. Scrotal ultrasound performed in longitudinal, transverse and oblique scans using a high frequency linear probe with grayscale and color-doppler; transrectal prostate ultrasound performed with transverse, longitudinal and oblique scans using an "end fire" probe; basal penile ultrasound will be performed in longitudinal and transverse scans using a high frequency linear probe with grayscale and color-doppler; dynamic penile ultrasound performed as described for basal penile ultrasound after intra-cavernous infiltration of 10 mcg of prostaglandin-E1 (PGE1).
  • Diagnostic Test: Assessment of reproductive function of LO-COCO-ANDRO male patients
    Semen samples will be collected on site by masturbation directly into a sterile plastic container after 3-5 days of sexual abstinence. The sample will be analyzed according to World Health Organization (WHO) 2010 guidelines. Semen samples will be stored for biochemical and molecular evaluations.
  • Diagnostic Test: Assessment of sexual function of LO-COCO-ANDRO male patients
    Validated questionnaires to assess the prevalence of male sexual disorders, namely erectile dysfunction with International Index of Erectile function 15 (IIEF-15), premature ejaculation with premature ejaculation diagnostic tool (PEDT), hypoactive sexual desire disorder with andrological structured interview on erectile dysfunction (ANDRO-SIEDY). Patients will be also interviewed to evaluate lifestyle habits.
  • Diagnostic Test: Assessment of olfactory function of LO-COCO-ANDRO male and female patients

    Brief interview to collect patient's anamnesis relative to olfactory function, with particular reference to hypo / anosmia and hypo/ageusia onset timeline, duration and regression.

    Interview for the self-assessment of chemosensory skills and for the evaluation of quality of life in relation to olfactory dysfunction.

    Sniffin 'Sticks test for the evaluation of odor threshold (T), odor discrimination (D) and odor identification (I) (TDI score).



Primary Outcome Measures :
  1. Identification of the most frequent phenotypes of Long-COVID syndrome among COVID-19 patients recently hospitalized and dismissed [ Time Frame: Change from baseline at 3-12 months ]
    This pilot study will allow identifying the frequency and type of andrological, reproductive, sexual and olfactory disorders that contribute to the long covid syndrome.


Secondary Outcome Measures :
  1. Number of patients with andrological dysfunctions [ Time Frame: Change from baseline at 3-12 months ]
    Prevalence of andrological dysfunctions (hypogonadism, morpho-structural alterations of the testis including testicular hypotrophy, testicular and / or epididymal inhomogeneity, testicular calcifications / microlithiasis, testicular solid lesions, hydrocele, varicocele, altered testicular and / or epididymal vascularization, prostate-vesicular morpho-structural alterations, morpho-structural and hemodynamic alterations of the penis including nodules, alterations of the albuginea tunic, presence of fibrotic or calcified plaques, morphological and haemodynamic alterations of the cavernous arteries, anastomosis between the cavernous arteries and the dorsal artery, collateral circulation, occlusions).

  2. Number of patients with reproductive dysfunctions [ Time Frame: Change from baseline at 3-12 months ]
    Prevalence of male reproductive dysfunctions: alterations of seminal parameters (oligo-, astheno-, teratozoospermia, azoospermia, necrozoospermia, leukocytospermia, hypo / hyperposia).

  3. Number of patients with sexual dysfunctions [ Time Frame: Change from baseline at 3-12 months ]
    Prevalence of male sexual dysfunctions (erectile dysfunction, premature ejaculation, hypoactive sexual desire disorder).

  4. Number of patients with olfactory dysfunctions [ Time Frame: Change from baseline at 3-12 months ]
    Prevalence of olfactory dysfunctions (hypo/anosmia and hypo/ageusia) in male and female patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients of both sexes recovered from SARS-CoV-2 infection
Criteria

Inclusion Criteria:

  • Patients of both sexes recovered from SARS-CoV-2 infection (two negative nasopharyngeal swabs, negative IgM and positive anti SARS-CoV-2 IgG);
  • Aged over 18 years of age;
  • Ability to understand protocol procedures

Exclusion Criteria:

  • Any psychological/psychiatric/other medical conditions compromising the understanding of the nature and purpose of the study, and of its possible consequences
  • Uncooperative attitude of the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05379556


Contacts
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Contact: Rosario Pivonello, Prof. 3317328474 rosario.pivonello@unina.it

Locations
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Italy
Federico II University of Naples Recruiting
Naples, Italy, 80131
Contact: Rosario Pivonello, Prof.    3317328474    rosario.pivonello@unina.it   
Sponsors and Collaborators
Federico II University
Azienda Sanitaria Locale Napoli 2 Nord
Investigators
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Principal Investigator: Rosario Pivonello, Prof. Federico II University
Publications:

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Responsible Party: Prof. Rosario Pivonello, Clinical Professor, Federico II University
ClinicalTrials.gov Identifier: NCT05379556    
Other Study ID Numbers: LO-COCO-ANDRO
First Posted: May 18, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Rosario Pivonello, Federico II University:
Long Covid-19
Andrological complications
Reproductive complications
Sexual complications
Olfactory complications
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases