This is a Phase 2 prospective, randomized, placebo-controlled, double-blinded, parallel group, single administration, multi-center study to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants (adults ≥50years) with asymptomatic or mild COVID-19
The study consists of 2 parts: Part I - to identify the Recommended Phase 2 Dose (RP2D) compared to placebo in elderly participants (adults ≥50 years) with asymptomatic or mild COVID-19. These patients will be treated with 120 and 240 µg/kg efineptakin alfa, given on Day 1 (Baseline), respectively. The study will evaluate the safety, tolerability, and pharmacodynamics variable (ALC) of efineptakin alfa against COVID-19. Part II - to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants with asymptomatic or mild COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
210
Recombinant human interleukin-7 hybrid Fc
Mitra Keluarga Kelapa Gading
Jakarta Pusat, Indonesia
RECRUITINGMitra Keluarga Kemayoran
Jakarta Pusat, Indonesia
RECRUITINGDose finding
MTD and RP2D based on safety profiles
Time frame: 9 weeks
Absolute lymphocyte count (ALC)
The change of absolute lymphocyte count from baseline
Time frame: 9 weeks
Treatment related Adverse Events
The proportion of participants with treatment emergent adverse events
Time frame: 10 weeks
Status of COVID-19 infection
Decrease of viral shedding identified with nasopharyngeal swab specimen by RT-PCR test
Time frame: 9 weeks
To evaluate the efficacy of GX-I7 in patients with COVID-19
The proportion of participants who have progressed to moderate or severe or critical illness
Time frame: 9 weeks
Improvement in clinical parameters
Time to clinical improvement: clinical improvement is defined as a ≥ 2-point improvement in clinical status (8-point ordinal scale) from Day 1 (baseline)
Time frame: 9 weeks
Assess in improvement in clinical parameters
Time to ≥ 1-point improvement (days) from Day 1 (baseline) in terms of clinical status
Time frame: 9 weeks
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