SARS Cov-2 in Conjunctival Secretion in COVID-19 Patients

Sars-CoV2 Clinical Trial

Official title:

SARS Cov-2 in Conjunctival Secretions in an Italian Lombardia Cohort of Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402853
• Other study ID #: 72/2020
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: May 20, 2020

Study information

• Verified date: December 2020
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions.

Description:

Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory syndrome started in China and rapidly spread all over the world and in particular in northern Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as the high population density with more possibilities of interpersonal contact, high prevalence of respiratory pathologies, in particular in elderly people, due to pollution, high number of contacts with Chinese population for travelling and business reasons, and at last the non-windy temperate climate conditions, that increases the persistence of virus in the environment.

At now, more than eighty thousand citizens from Lombardia Region have been officially affected by the disease with a high death toll, also considering that actual numbers are certainly much underestimated.

The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and to correlate virus presence to concomitant systemic clinical conditions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 20, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized COVID 19 patients

Exclusion Criteria:

• Patients with respiratory support that interferes with tears sampling

Related Conditions & MeSH terms

• Sars-CoV2
• Tear

Intervention

Diagnostic Test:
• Tears swab
rtPCR on tears swabs samples

Locations

Country	Name	City	State
Italy	ASST Sette Laghi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARS-CoV-2 in patients confirmed with COVID-19. Acta Ophthalmol. 2020 Apr 26. doi: 10.1111/aos.14445. [Epub ahead of print] — View Citation

Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virus presence in COVID 19 patients tears	prevalence of SARS CoV 2 virus on tears	1 day
Secondary	Concordance to Naso-Pharingeal Swab	Evaluation of concordance with Naso-Pharingeal testing	1 day

External Links

•   tears and infection