COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=042-20

Jose Carlos Sandoval

jose.c.sandoval@gsk.com

2020-08-21

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1) Age &#8805,18 years and &#8804,79 years 2) Have positive SARS-CoV-2 result 3) Be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan) 4) Be developing new onset of oxygenation impairment requiring any of the following: high-flow oxygen (&#8805,15L/min), non-invasive ventilation (e.g. CPAP, iPAP), mechanical ventilation &#8804,48h prior to dose 5) Have increased biological markers of systemic inflammation. 6) No gender restriction 7) Female participants must meet and agree to abide by the contraceptive criteria. 8) Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures. For more details check the protocol

1) Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. 2) Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU 3) Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose (>0.15ug/kg/min) noradrenaline (or equivalent) or more than one vasopressor 4) Current serious or uncontrolled medical condition or abnormality of clinical 5) Untreated systemic bacterial, fungal, viral, or other infection 6) Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB 7) Known HIV regardless of immunological status 8) Known HBsAg and/or anti-HCV positive 9) Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy 10) Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors within the last 3 months prior to randomization 11) Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization 12) History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy For more details check the protocol

2

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED;

18

79

Argentina;Belgium;Brazil;India;Canada;Chile;Colombia;France;Japan;Mexico;Peru;Poland;South Africa;Spain;Sweden;United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

35

Outcome name:To compare the efficacy of otilimab 90 mg IV versus placeboMeasure:To compare the efficacy of otilimab 90 mg IV versus placeboTimepoints:28 days

Phase 2

[{"arm_notes": "", "treatment_id": 940, "treatment_name": "Otilimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]