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baricitinib (n=4148) vs. standard of care (n=4008)
randomized controlled trial
baricitinib 4 mg once daily
baricitinib 4 mg once daily by mouth for 10 days or until discharge if sooner
usual standard of care alone
COVID 19 all comers
open-label
baricitinib (n=764) vs. placebo (n=761)
randomized controlled trial
Once-daily baricitinib (4 mg) or up to 14 days
Placebo
Standard of care included systemic corticosteroids, such as dexamethasone, and antivirals, including remdesivir.
COVID 19 hospitalized
laboratory-confirmed SARS-CoV-2 infection, had evidence of pneumonia or active and symptomatic COVID-19, and had at least one elevated inflammatory marker (C-reactive protein, D-dimer, lactate dehydrogenase, or ferritin. were excluded if, at study entry, they required invasive mechanical ventilation (National Institute of Allergy and Infectious Disease Ordinal Scale [NIAID-OS] score 7); were receiving immunosuppressants (high-dose corticosteroids, biologics, T-cell-targeted or B-cell-targeted therapies, interferon, or JAK inhibitors); had ever received convalescent plasma or intravenous immunoglobulin for COVID-19; or had neutropenia (absolute neutrophil count <1000 cells per μL), lymphopenia (absolute lymphocyte count <200 cells per μL), alanine aminotransferase (ALT) or aspartate aminotransferase concentration greater than five times the upper limit of normal, or an estimated glomerular filtration rate (eGFR) of less than 30 mL/min per 1·73 m2
Double-blind.
101 centres across 12 countries in Asia, Europe, North America, and South America.
according graphical testing procedure used to test results in a hierarchical manner for controlling the overall family-wise type I error rate (appendix 6 p 14), the twoprimary analyses were at the top of the hierarchy. Population 1 was tested at 99% of the total alpha (0.05) and Population 2 at 1% of 0.05.
because the primary outcome was not statistically significant in the prespecified hierarchical graphical testing procedure, none of the key secondary outcomes could be considered statistically significant using this same procedure.
baricitinib (n=515) vs. placebo (n=518)
randomized controlled trial
baricitinib (≤14 days) and remdesivir (≤10 days)
baricitinib 4-mg daily dose (either orally [two 2-mg tablets] or through a nasogastric tube) for 14 days or until hospital discharge
remdesivir (≤10 days) (and placebo)
remdesivir intravenously as a 200-mg loading dose on day 1, followed by a 100-mg maintenance dose administered daily on days 2 through 10 or until hospital discharge or death
COVID 19 hospitalized
double-blind
67 trial sites in 8 countries
tofacitinib (n=144) vs. placebo (n=145)
randomized controlled trial
tofacitinib at a dose of 10 mg twice daily
for up to 14 days or until hospital discharge
placebo
COVID 19 hospitalized
patients 18 years of age or older who had laboratory-confirmed SARS-CoV-2 infection as determined on RT-PCR assay before randomization, who had evidence of Covid-19 pneumonia on radiographic imaging, and who had been hospitalized for less than 72 hours.The main exclusion criteria were the use of noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) on the day of randomization, a history of thrombosis or current thrombosis, known immunosuppression, and any current cancer for which the patient was receiving active treatment.
double blind
15 sites in Brazil
baricitinib (n=51) vs. placebo (n=50)
randomized controlled trial
Baricitinib
Baricitinib 4mg once daily for up to 14 days, or until discharge from hospital, in combination with standard of care.
Placebo
Matched placebo once daily for up to 14 days in combination with standard of care.
All participants received standard of care in keeping with local clinical practice for COVID-19 management, which could include concomitant medications such as corticosteroids, antivirals, and other treatments, including vasopressors.
COVID-19 severe or critically
Double-blind.
18 hospitals in Argentina, Brazil, Mexico, and the USA.
As the cohort reported here was an addition to the parent trial study design, all endpointsare considered exploratory.
Exploratory trial which followed the study design of COV-BARRIER in a critically ill cohort not included in the main phase 3 trial.
ruxolitinib (n=21) vs. vitamin C (n=21)
randomized controlled trial
Ruxolitinib
Oral intake of ruxolitinib 5mg twice a day plus standard-of-care.
Vitamin C
100 mg vitamin C twice a day with SoC treatment.
Standard of care in both groups. The SoC treatment included antiviral therapy, supplemental oxygen, noninvasive and invasive ventilation, corticosteroid, antibiotic agents,vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.
COVID-19 severe or critically
(1) met the diagnostic criteria for COVID-19; (2) 18 years or older and younger than 75 years; (3) severe cases. patients in need of invasive mechanic ventilation at recruitment were ecluded.
Single-blind.
Multicenter, 3 hospitals in China.
Phase II.
TD-0903 10mg (n=6) vs. placebo (n=6)
randomized controlled trial
TD-0903 10mg
Once-daily inhalation of TD-0903 10 mg (no loading dose) for up to 7 days.
Placebo
Matched placebo via inhalation for up to 7 days.
Phase IIa 4 arms: 3 different doses of TD-0903 (1mg, 3mg, 10mg) and placebo.
COVID-19 severe or critically
Patients 18 to 80 years of age with PCR confirmed, symptomatic COVID-19 (symptoms for 3–14 days) who were hospitalized and required supplemental oxygen to maintain saturation >90%.
Double-blind.
Multicenter: UK, Moldova, Ukraine.
Key safety outcomes were change from baseline in vital signs and clinical laboratory results, and incidence and severity of treatment-emergent AEs; key pharmacokinetic (PK) endpoints were plasma PK parameters on Days 1 and 7, and the key pharmacodynamic outcome was change from baseline SaO2/FiO2 ratio. Other clinical outcomes were considered exploratory.
Phase IIa (ascending-dose study).
TD-0903 1mg (n=6) vs. placebo (n=6)
randomized controlled trial
TD-0903 1mg
Once-daily inhalation of TD-0903 1 mg (Day 1 loading dose 2mg) for up to 7 days
Placebo
Matched placebo via inhalation for up to 7 days.
Phase IIa 4 arms: 3 different doses of TD-0903 (1mg, 3mg, 10mg) and placebo.
COVID-19 severe or critically
Patients 18 to 80 years of age with PCR confirmed, symptomatic COVID-19 (symptoms for 3–14 days) who were hospitalized and required supplemental oxygen to maintain saturation >90%.
Double-blind.
Multicenter: UK, Moldova, Ukraine.
Key safety outcomes were change frombaseline in vital signs and clinical laboratory results, and incidence and severity of treatment-emergent AEs; key pharmacokinetic (PK) endpoints were plasma PK parameters on Days 1 and 7, and the key pharmacodynamic outcome was change from baseline SaO2/FiO2 ratio. Other clinical outcomes were considered exploratory.
Phase IIa (ascending-dose study).
TD-0903 3mg (n=7) vs. placebo (n=6)
randomized controlled trial
TD-0903 3mg
Once-daily inhalation of TD-0903 3mg (Day 1 loading dose 6mg) for up to 7 days.
Placebo
Matched placebo via inhalation for up to 7 days.
Phase IIa 4 arms: 3 different doses of TD-0903 (1mg, 3mg, 10mg) and placebo.
COVID-19 severe or critically
Patients 18 to 80 years of age with PCR confirmed, symptomatic COVID-19 (symptoms for 3–14 days) who were hospitalized and required supplemental oxygen to maintain saturation >90%.
Double-blind.
Multicenter: UK, Moldova, Ukraine.
Key safety outcomes were change from baseline in vital signs and clinical laboratory results, and incidence and severity of treatment-emergent AEs; key pharmacokinetic (PK) endpoints were plasma PK parameters on Days 1 and 7, and the key pharmacodynamic outcome was change from baseline SaO2/FiO2 ratio. Other clinical outcomes were considered exploratory.
Phase IIa (ascending-dose study).
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