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

Pirogov Russian National Research Medical University

Status: Completed

Conditions: COVID-19; Mild to Moderate

Treatments: Drug: Netakimab; Other: Standard of care therapy; Drug: Baricitinib Oral Tablet; Drug: Tocilizumab Injection

Study type: Observational

Funder types: Other

Identifiers

NCT05302947

BaToNe-COV-2

075-15-2020-807 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

154 participants in 4 patient groups

Baricitinib

Description:

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

Treatment:

Drug: Baricitinib Oral Tablet

Tocilizumab

Description:

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

Treatment:

Drug: Tocilizumab Injection

Netakimab

Description:

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

Treatment:

Drug: Netakimab

Control

Description:

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

Treatment:

Other: Standard of care therapy