Assessment of Sexual Dysfunction Among COVID-19 Recovered Patients

COVID-19 Clinical Trial

Official title:

Assessment of Sexual Dysfunction Among COVID-19 Recovered Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05148819
• Other study ID #: PCSD
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: April 2023

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: Reham A Ibrahim, MBBS
• Phone: 1006033730
• Email: rehamabdalla[@]live.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Covid-19 pandemic has affected hundreds of millions globally(https ://coronavirus.jhu.edu/map.html), and hundreds of thousands in Egypt(https://www.care.gov.eg/EgyptCare/Index.aspx).

However, the long-term consequences of the disease are still largely unknown. Data from 2002-2004 epidemics of SARS suggest that cardiovascular sequelae, such as microangiopathy, cardiomyopathy and impaired endothelial function, are to be expected also in COVID-19 patients.(Vittori et al, 2020) Hyperinflammation and immunosuppression are prominently featured in COVID-19, causing a cytokine storm leading to development of micro-thrombosisand disseminated intravascular coagulation (DIC). (Jose et al, 2020).

These findings can be extremely relevant for male and female sexual health: indeed, based on these premises, there is quite enough evidence to hypothesize that consequences of COVID-19 can extend to sexual and reproductive health. (Sansone et al, 2020)

A self-administered questionnaire will be disseminated using online electronic social network (Facebook, What's App) including:

Sociodemographic age& gender. Sexual dysfunction will be assessed using International Index of Erectile Function-5 (IIEF-5) for males, and Arabic Female Sexual Function Index (ArFSFI) for females will be applied.

Covid-19 related factors.

Description:

The pandemic of coronavirus disease (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents a first-time challenge for healthcare. Despite of social distancing and isolation measures, the number of affected patients is growing daily. (Isidori et al, 2020) As of November 14th , 2021, more than 253.2 million COVID-19 cases have been confirmed worldwide, with more than 5 million deaths& more than 229.3 million subjects have recovered from COVID-19 worldwide. (https ://coronaviru s.jhu.edu/map.html)

While in Egypt more than 343 thousand COVID-19 cases with more than 19 thousand deaths have been confirmed& more than 282 thousand recoveries. (https://www.care.gov.eg/EgyptCare/Index.aspx)

However, the long-term consequences of the disease are still largely unknown. Data from 2002-2004 epidemics of SARS suggest that cardiovascular sequelae, such as microangiopathy, cardiomyopathy and impaired endothelial function, are to be expected also in COVID-19 patients. (Vittori et al, 2020)

Hyperinflammation and immunosuppression are prominently featured in COVID-19, causing a cytokine storm leading to development of micro-thrombosisand disseminated intravascular coagulation (DIC). (Jose et al, 2020)

This cytokine storm is strongly associated with the development of interstitial pneumonia (IP), however, although lungs are the primarily targeted organs, the cardiovascular system is globally affected.(Sun X et al, 2020)

Evidence in this regard supports the notion that the exaggerated production of early response proinflammatory cytokines, increases the risk of vascular hyperpermeability,possibly progressing to multiple organ failure and,ultimately, death.(Sansone et al, 2020)

Additionally, both venous and arterial thromboembolic complications as deep venous thrombosis (DVT) and stroke, including endothelial inflammation, have been reported. (Lodigiani et al, 2020)

Indeed, a growing body of evidence seems to support the theory that the endothelium is targeted by the SARS-CoV-2; (Sardu et al, 2020) most importantly, the endothelium expresses the protein angiotensin-converting enzyme 2 (ACE2),through which the virus can access host cells. (Zhang et al, 2020)

Endothelial dysfunctions, therefore, a pivotal determinant of COVID-19symptoms. (Jung et al, 2020)

These findings can be extremely relevant for male and female sexual health: indeed, based on these premises, there is quite enough evidence to hypothesize that consequences of COVID-19 can extend to sexual and reproductive health. (Sansone et al, 2020)

There is very limited literature on the incidence of sexual dysfunctions, particularly in women.(McCabe et al, 2016)

Studies on the incidence of sexual dysfunction in women are scarce and there is a deficiency of data available on this topic. In a recent study from the United Kingdom, Burri and Spector found that 5.8% of women reported symptoms that constituted a diagnosis of Female Sexual Dysfunction(FSD) and15.5% reported lifelong FSD.

There are few epidemiologic surveys addressing the incidence,as opposed to prevalence, of sexual disorders in men and there are large differences among existing studies. These differences can be explained by variations in study design, populations studied, and definitions of sexual dysfunctions. Because of these variations, itis impossible to specify the incidence of sexual dysfunctions inmen. Most research has been conducted on Erectile Dysfunction(ED). The most important common theme of the studies is that the incidence of sexual dysfunctions increases with age. (McCabe et al, 2016)

A self-administered questionnaire will be disseminated using online electronic social network (Facebook, What's App) including:

1. Sociodemographic age& gender.

2. Sexual dysfunction will be assessed using International Index of Erectile Function-5 (IIEF-5) for males, and Arabic Female Sexual Function Index (ArFSFI) for females will be applied.

3. Covid-19 related factors:

1. Duration of infection

2. Fever

3. Duration since recovery (in months)

4. Diagnosis done by (PCR, rapid test, other)

5. Complications (respiratory, vascular, cardiac, other)

6. Quarantine (ICU, hospital, home, other)

7. Positive family of positive COVID-19

8. Spouse's sexual function

9. Anticoagulants and antiplatelets

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 384
• Est. completion date: April 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 1. Age:

1. Men: 18-60 years

2. Women: 18- 50 years

2. Marital Status: Married

Exclusion Criteria:

Chronic Diseases:

Patients with known history of any chronic disease

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Isidori AM, Pofi R, Hasenmajer V, Lenzi A, Pivonello R. Use of glucocorticoids in patients with adrenal insufficiency and COVID-19 infection. Lancet Diabetes Endocrinol. 2020 Jun;8(6):472-473. doi: 10.1016/S2213-8587(20)30149-2. Epub 2020 Apr 23. — View Citation

Jose RJ, Manuel A. COVID-19 cytokine storm: the interplay between inflammation and coagulation. Lancet Respir Med. 2020 Jun;8(6):e46-e47. doi: 10.1016/S2213-2600(20)30216-2. Epub 2020 Apr 27. — View Citation

Lodigiani C, Iapichino G, Carenzo L, Cecconi M, Ferrazzi P, Sebastian T, Kucher N, Studt JD, Sacco C, Bertuzzi A, Sandri MT, Barco S; Humanitas COVID-19 Task Force. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020 Jul;191:9-14. doi: 10.1016/j.thromres.2020.04.024. Epub 2020 Apr 23. — View Citation

Sansone A, Mollaioli D, Ciocca G, Limoncin E, Colonnello E, Vena W, Jannini EA. Addressing male sexual and reproductive health in the wake of COVID-19 outbreak. J Endocrinol Invest. 2021 Feb;44(2):223-231. doi: 10.1007/s40618-020-01350-1. Epub 2020 Jul 13. Review. — View Citation

Sun X, Wang T, Cai D, Hu Z, Chen J, Liao H, Zhi L, Wei H, Zhang Z, Qiu Y, Wang J, Wang A. Cytokine storm intervention in the early stages of COVID-19 pneumonia. Cytokine Growth Factor Rev. 2020 Jun;53:38-42. doi: 10.1016/j.cytogfr.2020.04.002. Epub 2020 Apr 25. Review. — View Citation

Vittori A, Lerman J, Cascella M, Gomez-Morad AD, Marchetti G, Marinangeli F, Picardo SG. COVID-19 Pandemic Acute Respiratory Distress Syndrome Survivors: Pain After the Storm? Anesth Analg. 2020 Jul;131(1):117-119. doi: 10.1213/ANE.0000000000004914. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the prevalence of sexual dysfunction among covid-19 survivors.		December 2022
Secondary	To evaluate and compare the duration since recovery and sexual dysfunction. 3- To evaluate and compare the duration since recovery and sexual dysfunction. 3- To evaluate and compare the duration since recovery and sexual d		December 2022