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Clinical Trial Summary

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


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04810637
Study type Interventional
Source PT Kalbe Genexine Biologics
Contact Paritosh Keertikar, PhD
Phone +65 9730 6164
Email paritosh.keertikar@innogene.com.sg
Status Recruiting
Phase Phase 2
Start date November 1, 2020
Completion date September 2021

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