COVID-19 Study at the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU

NCT05302947 | Completed FDA Drug

• 2 other identifiers: BaToNe-COV-2075-15-2020-807
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

This is a retrospective observational cohort study. About 1000 hospital charts of adult patients admitted to the hospital with mild-to-moderate COVID-19 from February to August 2020 were analyzed to evaluate the inflammatory markers and clinical outcomes. The aim of this study was to compare the observed results of targeted immunosuppressive therapy, anti-IL-6R (Tocilizumab), anti-IL-17A (Netakimab), and JAK1/JAK2 inhibitor (Baricitinib), with standard-of-care (SOC) therapy. The investigators hypothesize that, as compared to SOC therapy, all target drugs will demonstrate at least similar beneficial effects. This observation may additionally support a rational choice for mild-to-moderate COVID-19 treatment strategy, considering the general safety profile and patient-specific limitations.

Conditions

COVID-19; Mild to Moderate

Keywords

tocilizumab; baricitinib; netakimab; anti-IL-17; c-reactive protein; lactic dehydrogenase; neutrophil-to-lymphocyte ratio

Outcome Measures

Primary Outcomes (1)

• Changing in the level of C-reactive protein

  The level of C-reactive protein (mg/L ) was measured by ELISA on the day of the start of therapy and then after 72 hours and 120 hours

  5 days

Secondary Outcomes (5)

• Changing in the level of Lactate dehydrogenase

  5 days

• Assessment of the absolute lymphocyte count in dynamic

  5 days

• Assessment of the absolute neutrophil count in dynamic

  5 days

• Assessment of the neutrophil-to-lymphocyte ratio

  5 days

• Changing of the National Early Warning Score2

  5 days

Other Outcomes (1)

• Hospital discharge day and mortality data

  21 days

Study Arms (4)

Baricitinib

group included patients received Baricitinib in addition to standard of care therapy

Drug: Baricitinib Oral Tablet

Tocilizumab

group included patients received Tocilizumab in addition to standard of care therapy

Drug: Tocilizumab Injection

Netakimab

group included patients received Netakimab in addition to standard of care therapy

Drug: Netakimab

Control

group included patients received only standard of care therapy at the time of hospital admission according to the corresponding COVID-19 Russian guidelines 2020.

Other: Standard of care therapy

Interventions

Baricitinib Oral Tablet DRUG

Baricitinib was administered at a dose of 4 mg once or twice per day for 3-8 days (5 days on average) depending on the individual patients' condition

Also known as: Olumiant

Baricitinib

Tocilizumab Injection DRUG

Tocilizumab was administered by a single intravenous dose of 400 mg

Also known as: Actemra

Tocilizumab

Netakimab DRUG

Netakimab was administered by a single subcutaneous injection of 120 mg

Also known as: Efleira

Netakimab

Standard of care therapy OTHER

SOC treatment included hydroxychloroquine (400 mg twice on day 1, followed by 200 mg twice per day on days 5-10), azithromycin (500 mg once per day for 5 days), lopinavir-ritonavir (400/100 mg twice per day for 14 days), and low molecular-weight heparin according to personal indicators

Also known as: SOC

Control

Eligibility Criteria

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

Study Population

Patients with confirmed COVID-19, hospitalized into the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU or the City Clinical Hospital No. 52 of the Department of Health of the City of Moscow from 02/01/2020 to 08/31/2020.

You may qualify if:

• Subjects who meet all of the following criteria were included in the study:
• Patients were hospitalized in two Moscow specialized COVID-19 care units from 02/01/2020 to 08/31/2020.
• Patients had symptoms of acute respiratory infection (fever, muscle pain, cough) and radiologically-defined viral pneumonia as assessed by computed tomography
• All patients written informed consent for 'off-label' drug use for persons who received tocilizumab, netakimab, or baricitinib

You may not qualify if:

• Subjects who meet any of the following criteria were excluded from participation in the study:
• Pregnant women
• Patients with unknown National Early Warning Score 2 (NEWS2) metric or with NEWS2 \> 6 points on the first day of therapy
• Patients with the plasma level of CRP \> 140 mg/l on the first day of therapy
• Information about the outcome of patients (death or discharge from the hospital) was absent
• Patients who first time got the investigational drug later than 72 hours after hospitalization
• Patients who received a combination of the investigational drugs or application was differed to study design
• Patients with severe hematological, renal, or liver function impairment or evidence of concomitant bacterial infections.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead
• City Clinical Hospital No.52 of Moscow Healthcare Department: collaborator

Study Sites (2)

City Clinical Hospital No. 52 of the Department of Health of the City of Moscow

Moscow, 123182, Russia

Location

Pirogov Russian National Research Medical University

Moscow, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

baricitinib; tocilizumab; netakimab

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

Study Officials

• Zinaida Yu Mutovina, MD-PhD

  City Clinical Hospital No.52 of Moscow Healthcare Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Chudakov D.M., D.Sc., Director of Research Institute of Translational Medicine, Head of the Department of molecular technologies

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: March 31, 2022
• Study Start: February 1, 2020
• Primary Completion: August 31, 2020
• Study Completion: June 30, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)