COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04730427

Minkyu Heo

mkheo@genexine.com

2021-01-29

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

key inclusion criteria: subjects who have been confirmed to be covid-19 corresponding to mild cases of severity categorization classified by fda through polymerase chain reaction (pcr) test or virus gene test (sequencing) and who can be available to be administered within seven days from the date of manifestation. subjects who are or will be inpatient. key

patients with symptoms of moderate or higher in the severity classification presented by fda have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc) subjects with infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the ip administration

2

Genexine, Inc.

19

100

Korea;Republic of

Mild disease at enrollment

1: Mild disease at enrollment

10

Dose limiting toxicity (DLT);Incidence rate, characteristics, and severity of adverse reactions;Shift from baseline of blood chemistry;Shift from baseline of hematology;Shift from baseline of physical examination;Shift from baseline of vital sign

None

Phase 1

[{"arm_notes": "", "treatment_id": 448, "treatment_name": "Efineptakin alfa", "treatment_type": "Interleukins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]