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

Sponsor
Pirogov Russian National Research Medical University
Study ID
NCT05302947
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Tocilizumab Injection — DRUG
    Tocilizumab was administered by a single intravenous dose of 400 mg
  • Netakimab — DRUG
    Netakimab was administered by a single subcutaneous injection of 120 mg
  • 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

Study Details

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.

Key Dates

Start date
Feb 1, 2020
Status verified
Mar 2022
Primary completion
Aug 31, 2020
Completion
Jun 30, 2021

Study Design

Enrollment
154 participants (actual)

Arms

  • Arm: Baricitinib
    group included patients received Baricitinib in addition to standard of care therapy
  • Arm: Tocilizumab
    group included patients received Tocilizumab in addition to standard of care therapy
  • Arm: Netakimab
    group included patients received Netakimab in addition to standard of care therapy
  • Arm: 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.

Primary Outcome Measure

Changing in the level of C-reactive protein [ Time Frame: 5 days ]

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