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

NCT ID: NCT05302947

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-06-30

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.

Detailed Description

The clinical data from 154 patients were retrospectively collected according to Inclusion and Exclusion criteria. Finally all patients were divided into four groups depending on therapy: 38 patients who received Baricitinib and SOC; 34 patients who received Tocilizumab and SOC; 48 patients who received Netakimab and SOC and 34 patients who received only SOC.

For all patients the investigators assessed the National Early Warning Score2 (NEWS2), absolute neutrophil count (ANC), absolute lymphocyte count (ALC) and blood neutrophil-to-lymphocyte ratio (NLR) at baseline (0 h, the day of therapy started) and after 72 hours (3 days) and 120 hours (5 days) of therapy. The individual dynamics of c-reactive protein (CRP) and lactate dehydrogenase (LDH) were assessed for patients with known parameters at baseline and 72 h (Δ0-72) or at baseline and 120 h (Δ0-120) to avoid excluding from the analysis patients who lacked CRP or LDH data at one of the time points. The individual dynamics of CRP and LDH for patients for whom the results of sequential measurements were available for all three time points was also assessed separately.

Additionally, the clinical outcomes (death or hospital discharge) and amount of days in hospital after starting therapy were estimate for all 154 patients.

Conditions

COVID-19; Mild to Moderate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Baricitinib

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

Baricitinib Oral Tablet

Intervention Type: 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

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

Tocilizumab Injection

Intervention Type: DRUG

Tocilizumab was administered by a single intravenous dose of 400 mg

Netakimab

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

Netakimab

Intervention Type: DRUG

Netakimab was administered by a single subcutaneous injection of 120 mg

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.

Standard of care therapy

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Tocilizumab Injection

Tocilizumab was administered by a single intravenous dose of 400 mg

Intervention Type: DRUG

Netakimab

Netakimab was administered by a single subcutaneous injection of 120 mg

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

Olumiant; Actemra; Efleira; SOC

Eligibility Criteria

Inclusion Criteria

Subjects who meet all of the following criteria were included in the study:

1. Patients were hospitalized in two Moscow specialized COVID-19 care units from 02/01/2020 to 08/31/2020.

2. Patients had symptoms of acute respiratory infection (fever, muscle pain, cough) and radiologically-defined viral pneumonia as assessed by computed tomography

3. All patients written informed consent for 'off-label' drug use for persons who received tocilizumab, netakimab, or baricitinib

Exclusion Criteria

Subjects who meet any of the following criteria were excluded from participation in the study:

1. Pregnant women

2. Patients with unknown National Early Warning Score 2 (NEWS2) metric or with NEWS2 > 6 points on the first day of therapy

3. Patients with the plasma level of CRP > 140 mg/l on the first day of therapy

4. Information about the outcome of patients (death or discharge from the hospital) was absent

5. Patients who first time got the investigational drug later than 72 hours after hospitalization

6. Patients who received a combination of the investigational drugs or application was differed to study design

7. Patients with severe hematological, renal, or liver function impairment or evidence of concomitant bacterial infections.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

City Clinical Hospital No.52 of Moscow Healthcare Department

OTHER

Sponsor Role: collaborator

Pirogov Russian National Research Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dmitry Chudakov

Professor Chudakov D.M., D.Sc., Director of Research Institute of Translational Medicine, Head of the Department of molecular technologies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zinaida Yu Mutovina, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

City Clinical Hospital No.52 of Moscow Healthcare Department

Locations

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

Moscow, , Russia

Pirogov Russian National Research Medical University

Moscow, , Russia

Countries

Russia

Other Identifiers

075-15-2020-807

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BaToNe-COV-2

Identifier Type: -

Identifier Source: org_study_id