Baricitinib Oral Tablet
DrugBaricitinib 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
Other names: Olumiant
NCT Number: NCT05302947
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
City Clinical Hospital No. 52 of the Department of Health of the City of Moscow, Moscow, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects who meet all of the following criteria were included in the study:
Exclusion criteria
Subjects who meet any of the following criteria were excluded from participation in the study:
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
Other names: Olumiant
Tocilizumab was administered by a single intravenous dose of 400 mg
Other names: Actemra
Netakimab was administered by a single subcutaneous injection of 120 mg
Other names: Efleira
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
Other names: SOC
Time frame: 5 days
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
Time frame: 5 days
The blood level of lactate dehydrogenase (LDH, U/L) was estimate by enzymatic UV-Kinetic method on the day of the start of therapy and then after 72 hours and 120 hours.
Time frame: 5 days
The absolute lymphocyte count (ALC) was assessed by using an automatic hematology analyzer on the day of the start of therapy and then after 72 hours and 120 hours.
Time frame: 5 days
The absolute neutrophil count (ANC) was assessed by using an automatic hematology analyzer on the day of the start of therapy and then after 72 hours and 120 hours.
Time frame: 5 days
The mathematical ratio of ANC to ALC were calculated for timepoints 0 ( the day of the start of therapy), 3 (72 hours after the start of the therapy) and 5 (120 hours after the start of the therapy)
Time frame: 5 days
The National Early Warning Score2 (NEWS2) metric based on physiological variables including blood pressure, heart rate, respiratory rate, temperature, oxygen saturation, and level of consciousness and falls on a scale of 0 to 20. NEWS2 value at 0-4 points corresponds to low clinical risk, 5-6 points to medium risk and 7 or more points to high clinical risk. NEWS2 was estimate on the day of the start of therapy and then after 72 hours and 120 hours.
Time frame: 21 days
The amount of days in the hospital after the start of therapy was estimated for each patients and and analysed as the following groups: less than 4 days in hospital; 5-7 days in hospital; 8-14 days in hospital; more than 15 days in hospital. Outcome (hospital discharge or death) was assessed on the last day of follow-up, the longest period of hospitalisation was 21 days.
Pirogov Russian National Research Medical University
Other
Tocilizumab, Netakimab, and Baricitinib Versus Standard of Care Therapy in Patients With Mild to Moderate COVID-19 - a Retrospective Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04794829
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial DetailsNCT07552779
COVID-19, COVID-19 (Coronavirus Disease 2019)
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial DetailsNCT07722000
COVID-19, Chronic Disease
Banī Suwayf, Beni Suweif Governorate, Egypt
View Trial DetailsNCT04371432
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial Details