Retrospective Evaluation of Clinical, Virological and Serological Data in Patients With Mild Acute Upper Respiratory Tract Infections

NCT05134766 | Completed DMC

• 1 other identifier: CMA-R2107
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective analysis with subgroup evaluation Primary objectives of the data analysis study: 1 Retrospective analysis of the symptoms and quality of life data of patients with mild, acute (\<96 hours) upper respiratory symptoms based on the results of standard health assessment questionnaires used at the institution, over a period of 10-15 days after the SARS CoV-2 PCR test. Secondary objectives 1 Retrospective assessment of the upper respiratory tract symptoms and quality of life and serological parameters of the contact persons with confirmed close exposure to SARS CoV-2 PCR positive patients (based on the results of the standard health assessment questionnaires used at the institution in the period of 10-15 days after the SARS CoV-2 PCR test) The retrospective analysis also includes an assessment of the pharmacological and supplementary therapies used in patients presenting with mild, acute (\<96 hours) upper respiratory symptoms and SARS CoV-2 positive contacts, as well as the incidence of SARS CoV-2 virus infection in contacts confirmed by PCR test (based on values measured within 48 hours and 10-15 days later), and an analysis of patients' serological data.

Conditions

Acute Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Change in conditions and symptoms

  Assessment of change in condition, change in symptoms based on standard completed online symptom diaries, based on retrospective analysis of the symptoms and quality of life data results of standard health assessment questionnaires used at the institution.

  baseline and every other day over a period of up to 15 days after the SARS CoV-2 PCR test competed.

Secondary Outcomes (1)

• Results of repeated PCR and serological tests

  baseline (d0-d2) and follow-up 10-15 days later

Other Outcomes (1)

• Pharmaco-therapies and supplementary therapies

  baseline (d0-d2) and a control 10-15 days later

Study Arms (6)

PCR positive

Those with a condition of the first SARS-CoV-2 PCR test result was positive. Based on data recorded in the period between 01 January 2021 to 30 June 2021

Other: Observation only

PCR negative

Those with a condition of the first SARS-CoV-2 PCR test result was negative. Based on data recorded in the period between 01 January 2021 to 30 June 2021

Other: Observation only

IgA/IgG positive

Those with a condition of the first IgA or IgG test result was at least once positive.

Other: Observation only

IgA/IgG negative

Those with a condition of the first IgA and IgG test results were both negative

Other: Observation only

Prevention only

Those with a condition of the first SARS-CoV-2 PCR test result was negative AND IgG /IGA negative.

Other: Observation only

W/Symptoms

Those that reported at least one positive symptom. Based on data recorded in the period between 01 January 2021 to 30 June 2021

Other: Observation only

Interventions

Observation only OTHER

Based on type of SOC applied and the type of CAM products by subject's own decison

IgA/IgG negative; IgA/IgG positive; PCR negative; PCR positive; Prevention only; W/Symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The objective of the research is retrospective data analysis based on the institution's own data, with their anonymous post-processing and analysis by subgroups, with special regard to the self-reported health assessment data on acute upper respiratory symptoms of the participating patients, their follow-up, and the results of relevant standard laboratory tests performed in the study period in the population determined on the basis of the selection criteria.

You may qualify if:

• Groups of patients who volunteer at the institution to have laboratory testing or laboratory sampling who
• present with symptoms of mild respiratory infection and have these symptoms for no more than 96 hours
• are at least 18 years old
• have requested and have had standard laboratory tests, blood sampling or SARS-CoV sampling provided by the institution in accordance with the institution's procedures,
• entered evaluable responses at least three times on the standard online health questionnaires provided by the institution,
• participated in at least 2 SARS CoV-2 sampling tests,
• and for whom no such clinical condition or other reason was identified during the data review and assessment by the principal investigator that could affect the integrity of the data

You may not qualify if:

• Subjects will be excluded from the analysis who:
• Have symptoms suggestive of moderate to severe condition:
• breathing rate: \> 21/min AND/OR
• extra oxygen demand (e.g. peripheral oxygen saturation measured on site \<96%)
• AND/OR clinical or radiological signs of pneumonia, or other conditions considered severe by the specialist, clinician or requiring hospitalization
• or were also hospitalized in connection with the COVID-19 disease
• Have infection-specific or COVID-19 disease-specific symptoms for more than 96 hours when first presenting, or
• Have a history of chronic ethyl consumption or smoking \>20 cigarettes per day, or suspected COPD

Sponsors & Collaborators

• Complex Medical Centre Deli Klinika: lead
• Herb-Pharma Sk, s.r.o.: collaborator
• Medix Clinical & Academic Research Consulting: collaborator

Study Sites (1)

Complex Medical Centre Deli Klinika

Budapest, 1012, Hungary

Location

Related Publications (8)

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  PMID: 34138966 BACKGROUND

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• Di Pierro F, Derosa G, Maffioli P, Bertuccioli A, Togni S, Riva A, Allegrini P, Khan A, Khan S, Khan BA, Altaf N, Zahid M, Ujjan ID, Nigar R, Khushk MI, Phulpoto M, Lail A, Devrajani BR, Ahmed S. Possible Therapeutic Effects of Adjuvant Quercetin Supplementation Against Early-Stage COVID-19 Infection: A Prospective, Randomized, Controlled, and Open-Label Study. Int J Gen Med. 2021 Jun 8;14:2359-2366. doi: 10.2147/IJGM.S318720. eCollection 2021.

  PMID: 34135619 BACKGROUND

• El-Anwar MW, Elzayat S, Fouad YA. ENT manifestation in COVID-19 patients. Auris Nasus Larynx. 2020 Aug;47(4):559-564. doi: 10.1016/j.anl.2020.06.003. Epub 2020 Jun 15.

  PMID: 32586739 BACKGROUND

• Rosas-Salazar C, Kimura KS, Shilts MH, Strickland BA, Freeman MH, Wessinger BC, Gupta V, Brown HM, Rajagopala SV, Turner JH, Das SR. SARS-CoV-2 infection and viral load are associated with the upper respiratory tract microbiome. J Allergy Clin Immunol. 2021 Apr;147(4):1226-1233.e2. doi: 10.1016/j.jaci.2021.02.001. Epub 2021 Feb 9.

  PMID: 33577896 BACKGROUND

• Ra SH, Lim JS, Kim GU, Kim MJ, Jung J, Kim SH. Upper respiratory viral load in asymptomatic individuals and mildly symptomatic patients with SARS-CoV-2 infection. Thorax. 2021 Jan;76(1):61-63. doi: 10.1136/thoraxjnl-2020-215042. Epub 2020 Sep 22.

  PMID: 32963115 BACKGROUND

• Costa R, Bueno F, Albert E, Torres I, Carbonell-Sahuquillo S, Barres-Fernandez A, Sanchez D, Padron C, Colomina J, Lazaro Carreno MI, Breton-Martinez JR, Martinez-Costa C, Navarro D. Upper respiratory tract SARS-CoV-2 RNA loads in symptomatic and asymptomatic children and adults. Clin Microbiol Infect. 2021 Dec;27(12):1858.e1-1858.e7. doi: 10.1016/j.cmi.2021.08.001. Epub 2021 Aug 9.

  PMID: 34384874 BACKGROUND

• Valle C, Martin B, Touret F, Shannon A, Canard B, Guillemot JC, Coutard B, Decroly E. Drugs against SARS-CoV-2: What do we know about their mode of action? Rev Med Virol. 2020 Nov;30(6):1-10. doi: 10.1002/rmv.2143. Epub 2020 Aug 11.

  PMID: 32779326 BACKGROUND

Study Officials

• Botond Lakatos, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 26, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)