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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Laboratory and instrumental examination

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129226
    • Recruiting
    • Russian Clinical Research Center for Gerontology
    • Contact: Olga Tkacheva, MD, PhD; Email: rgnkc@rgnkc.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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
  • Lung tissue lesion> 50% and / or according to computed tomography CT-2 and higher
  • Septic shock / sepsis
  • Development of multiple organ failure
  • Cytokine storm

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with severe COVID-19 pneumonia	Diagnostic test: Laboratory and instrumental examination; All patients will undergo a comprehensive examination to identify the consequences of COVID-19
Patients who had an asymptomatic COVID-19 3 months ago	Diagnostic test: Laboratory and instrumental examination; All patients will undergo a comprehensive examination to identify the consequences of COVID-19
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; All patients will undergo a comprehensive examination to identify the consequences of COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological changes in lung tissue according to CT data	CT scan	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Anticipated): May 15, 2021
• Study Completion (Anticipated): June 15, 2021

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: May 1, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: COVID_2020_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No