COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62438

Nanda Gamad

nanda.gamad@gmail.com

2021-11-08

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

18 years and above of either sex <br/ > Hospital admission within 10 days of RT-PCR positivity for COVID-19 <br/ > SpO2 <94% at room air and require low flow oxygen support- through nasal canula, <br/ > venturi mask or non-rebreather mask <br/ > Normal procalcitonin- <0.4 ng/mL with no other evidence of any co- or secondary <br/ > bacterial, viral or fungal infection at the time of randomization <br/ > Considered to be an appropriate participant for intervention with an immunomodulatory <br/ > in the opinion of the investigator <br/ > Should be able to be maintained on venous thromboembolism prophylaxis or current <br/ > maintenance therapy during inpatient dosing period, according to institutional protocol

Those who are on high flow oxygen or noninvasive or invasive mechanical ventilation or ECMO at the time of randomization <br/ > Those on steroids for more than 10 days for any indication <br/ > Patient has received baricitinib or any other immunomodulatory agent such as tumor <br/ > necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication within 4 weeks of the 1st dose of baricitinib <br/ > Patient has inability to supply direct informed consent or if it was not possible to obtain from Next of Kin or Independent Healthcare Provider on behalf of patient <br/ > Contraindications to study drugs, including history of hypersensitivity to the active substances or any of the excipients <br/ > Suspected or known active infections including but not limited to tuberculosis, hepatitis B or C (no blood screening required), herpes zoster or HIV. <br/ > Current or past (within 3 months) participation in any interventional clinical trial including COVID-19-related disease trials (observational studies allowed) <br/ > Patient moribund at presentation or screening or expected survival is <24h <br/ > Pregnant or lactating women at screening (or unwillingness to adhere to pregnancy <br/ > advice in protocol) <br/ > Either alanine transaminase or aspartate transaminase (ALT or AST) > 5 times the upper <br/ > limit of normal (ULN) <br/ > Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated <br/ > creatinine clearance < 30 ml /min) <br/ > Currently receiving or ever received hyperimmune globulin, convalescent plasma or <br/ > intravenous immunoglobulin [IVIg]) for COVID-19 <br/ > Patient has received neutralizing antibodies, such as bamlanivimab-etesevimab, <br/ > casirivimab-imdevimab and sotrovimab for COVID-19. <br/ > Patient has history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] <br/ > and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or has a history <br/ > of recurrent ( >1) VTE <br/ > Current diagnosis of active malignancy that, in the opinion of the investigator, could <br/ > constitute a risk when taking investigational product <br/ > Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern

2

PGIMER Chandigarh

18

100

India

Moderate disease at enrollment

3: Moderate disease at enrollment

260

Proportion of death or respiratory failureTimepoint: Day 28

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 181, "treatment_name": "Baricitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]