COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04380519

Mikhail Samsonov

Not reported

2020-05-08

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: the presence of a voluntarily signed and dated patient informed consent form for participation in this study, or a record of an medical consilium decision justifying patient's participation in case of patient is unable to state his/her will. having either of the following covid-associated respiratory syndromes: pneumonia with oxygenation saturation spo2 ≤93% (on room air) or respiratory rate greater than 30/min; acute respiratory distress syndrome (ards) ( pao2/fio2 ≤ 300 mmhg or spo2/fio2 ≤ 315 if pao2 is not available). covid-19 diagnosis based on: laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction method (pcr). or • bilateral changes in the lungs typical for covid-19, based on chest computed tomography results.

a history of hypersensitivity to the study drugs (rph-104 and/or okz), and/or their components. the presence of any of the following laboratory abnormalities: absolute neutrophil counts < 0.5 x 10^9 l white blood cell count < 2 x 10^9 l platelet count <50 x 10^9 l alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 3.0 x upper limit of normal (uln) severe renal failure: creatinine clearance < 30 ml/min septic shock (vasopressors are required to maintain mean arterial pressure ≥ 65 mm hg and lactate ≥ 2 mmol/l in the absence of hypovolemia) the disease progresses to death over the next 24 hours, regardless of treatment, according to investigator. perforation of the gastrointestinal tract, a history of diverticulitis. administration of plasma from covid-19 convalescent donors within 4 weeks before study enrollment and/or planned administration during the study. recent (less then 5 half-lives) administration of tocilizumab or sarilumab; recent (less then 5 half-lives) or planned during the current study period use of the following drugs: biologics (except rph-104 or okz) with immunosuppressive effect, including, but not limited to: interleukin-1 (il-1) inhibitors (anakinra, rilonacept, canakinumab), il- 6 inhibitors (except tocilizumab and sarilumab), il-17a inhibitors (secukinumab), tumor necrosis factor α (tnfα) inhibitors (infliximab, adalimumab, etanercept, etc.), antib-cell drugs, etc. other immunosuppressive drugs (with the exception of methotrexate in a dose of up to 25 mg/week), including, but not limited to: high doses of glucocorticoids (equivalent to prednisolone > 1 mg/kg) orally or parenterally; janus kinase (jak) kinase inhibitors; cyclophosphamide, etc. concurrent participation in another clinical trial. pregnancy, breastfeeding. a history of active tuberculosis, or active tuberculosis suspected by the investigator.

3

R-Pharm International, LLC

18

100

Russia

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

372

Proportion of Responders in Each Treatment Group

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1130, "treatment_name": "Rph-104", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 922, "treatment_name": "Olokizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]