COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04386616

Clinical Trials - Genentech, Inc.

global-roche-genentech-trials@gene.com

2020-05-13

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - hospitalized with covid-19 pneumonia confirmed per who criteria (including a positive pcr of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest x-ray or ct scan - peripheral capillary oxygen saturation (spo2) ≤93% (on room air or supplemental oxygen) or partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) ≤300 millimetres of mercury (mmhg) or requiring supplemental oxygen to maintain spo2 >93% or requirement for supplemental oxygen to maintain spo2 at an acceptable level per local standard of care

- pregnant or breastfeeding, or positive pregnancy test at screening - any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study - in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments - participating in another clinical drug trial - treatment with investigational therapy (other than for covid-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug - use of janus kinase (jak) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening - have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to day 1 - known hiv infection with cd4 <200 cells/microlitre (ul) or <14% of all lymphocytes - alt or ast >10 times the upper limit of normal (uln) detected at screening - history of anaplastic large-cell lymphoma or mantle-cell lymphoma - history of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment - clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ecg, laboratory assessment, or echocardiographic data - history of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment

3

Genentech, Inc.

18

None

Brazil;Mexico;Spain;United States

Severe disease at enrollment

6: Severe disease at enrollment

396

Time to Recovery, Defined as the Time to a Clinical Status Score of 1 or 2 on the 7-Category Ordinal Scale (Whichever Occurs First) by Day 28

None

Phase 2

[{"arm_notes": "Results for 2020-002713-17 available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002713-17/results", "treatment_id": 1342, "treatment_name": "Efmarodocokin alfa", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results for 2020-002713-17 available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002713-17/results", "treatment_id": 131, "treatment_name": "Astegolimab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results for 2020-002713-17 available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002713-17/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]