Optimization of Patients Long-term Management After the Coronavirus Infection COVID-19

NCT04871789 | Unknown DMC

• 1 other identifier: COVID_2020_01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

200 participants should be included in the study. There will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 months ago and 50 people who were in close contact with patients with confirmed coronavirus infection 3 months ago, but not sick and without antibodies to SARS-CoV-2. The study consists of two visits. At the first visit, after signing the consent to participate in the study, a screening examination will be performed to assess the criteria for inclusion and exclusion in the study. At the second visit, patients who meet the inclusion criteria and do not have exclusion criteria will undergo clinical and instrumental examination, and biological samples will be collected for laboratory testing. The aim of the study is to determine the most significant clinical and laboratory markers of the severity of the outcomes in the period of convalescence of the new coronavirus infection COVID-19. Clinical and laboratory indicators, the number and severity of signs of postcovid syndrome as well as pathological changes in lung tissue according to CT data in the group with covid pneumonia and indicators of immune status, hemostasis, endothelial dysfunction, inflammation, metabolism will be assessed.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• The presense of postcovid syndrome

  Clinical and laboratory indicators The number and severity of signs of postcovid syndrome

  through study completion, an average of 3 months

Secondary Outcomes (1)

• Pathological changes in lung tissue according to CT data

  through study completion, an average of 3 months

Study Arms (3)

Patients with severe COVID-19 pneumonia

Diagnostic Test: Laboratory and instrumental examination

Patients who had an asymptomatic COVID-19 3 months ago

Diagnostic Test: Laboratory and instrumental examination

People who had close contact with patients with confirmed COVID-19 3 months ago but did not get sick

Diagnostic Test: Laboratory and instrumental examination

Interventions

Laboratory and instrumental examination DIAGNOSTIC_TEST

All patients will undergo a comprehensive examination to identify the consequences of COVID-19

Patients who had an asymptomatic COVID-19 3 months ago; Patients with severe COVID-19 pneumonia; People who had close contact with patients with confirmed COVID-19 3 months ago but did not get sick

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men and women aged 18 and over with asymptomatic or severe course of the novel coronavirus infection COVID-19, or who have been in close contact with patients with confirmed coronavirus infection, but who are not sick and do not have antibodies to SARS-CoV-2

You may qualify if:

• For all groups:
• Informed consent signed by the patient.
• Men and women aged 18 and over.
• Group COVID-19 (asymptomatic):
• Confirmed diagnosis of COVID-19 (positive SARS-CoV-2 RNA PCR test or history of IgM and / or IgG antibodies to SARS-CoV-2)
• Absence of any clinical symptoms associated with coronavirus infection.
• Group Healthy:
• Contact with patients with symptomatic new coronavirus infection COVID-19 in the absence of personal protective equipment for at least 3 days.
• Absence of any clinical symptoms associated with coronavirus infection
• Group COVID symptomatic:
• Confirmed diagnosis of previous COVID-19 (positive SARS-CoV-2 RNA PCR test or presence of IgM antibodies to SARS-CoV-2) in history.
• A severe course of COVID-19, characterized by one or more of the following symptoms:
• Respiratory rate ≥ 30 in 1 min
• Blood oxygen saturation (SpO2) ≤ 93%
• The ratio of the partial tension of oxygen in arterial blood to the fraction of oxygen during inspiration (PaO2 / FiO2) \<300

You may not qualify if:

• Pregnancy
• Covid-19 vaccination
• Any serious medical illness before coronavirus infection, as well as a permanent form of atrial fibrillation
• Regular intake of anti-inflammatory, antibacterial, cytostatic and immunosuppressive drugs
• Refusal to participate in the study

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead
• Pfizer: collaborator

Study Sites (1)

Russian Clinical Research Center for Gerontology

Moscow, 129226, Russia

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Daria Kashtanova, MD, PhD

CONTACT

dr.kashtanova@gmail.com

Olga Tkacheva, MD, PhD

CONTACT

rgnkc@rgnkc.ru

Study Design

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

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: May 4, 2021
• Study Start: January 20, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 15, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-03

Locations

RU (1)