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

NCT05302947 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 154

Last updated 2022-04-08

No results posted yet for this study

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

Interventions

DRUG

Baricitinib Oral Tablet

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

DRUG

Tocilizumab Injection

Tocilizumab was administered by a single intravenous dose of 400 mg

DRUG

Netakimab

Netakimab was administered by a single subcutaneous injection of 120 mg

OTHER

Standard of care therapy

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

Sponsors & Collaborators

  • City Clinical Hospital No.52 of Moscow Healthcare Department

    collaborator OTHER

  • Pirogov Russian National Research Medical University

    lead OTHER

Principal Investigators

  • Zinaida Yu Mutovina, MD-PhD · City Clinical Hospital No.52 of Moscow Healthcare Department

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2020-08-31
Completion
2021-06-30
FDA Drug
Yes

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05302947 on ClinicalTrials.gov