NCT05656521

101-PGC-005 for the Treatment of COVID-19

A Prospective, Randomized, Comparative, Multi-centric, Adaptive Design Clinical Study to Evaluate Efficacy, Safety, and Tolerability of 101-PGC-005 ('005) for the Treatment of Moderate Corona Virus Disease (COVID-19) Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: 101 Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when used alongside standard of care (SOC) for the treatment of hospitalized patients with coronavirus disease (COVID-19).

Detailed description

The study is planned as an adaptive Phase II/III clinical study to allow for seamless transition to Phase III after completion of Phase II. The study will begin as initially only a Phase II to evaluate and compare the efficacy, safety, and tolerability of bolus injection of 20 mg '005 vs dexamethasone 6 mg injection for the treatment of COVID-19. The treatment period with the investigational product in the test group will be 3 consecutive days. However, in the comparator group, the patient will be allowed to take 6 mg dexamethasone daily for the duration of their treatment, based on the investigator's clinical judgement for a total of not more than 10 days or until the time of discharge, whichever is earlier. All patients in either test or control groups will be allowed to take other concomitant SOC as per the prescribed schedule for entire duration of the study, as applicable.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	101-PGC-005	'005 is a targeted prodrug of dexamethasone that binds to activated macrophages.
DRUG	Dexamethasone	Dexamethasone is a glucocorticoid commonly prescribed to treat inflammation.

Timeline

• Start date: 2023-01-31
• Primary completion: 2023-04-21
• Completion: 2023-06-01
• First posted: 2022-12-19
• Last updated: 2023-05-30

Locations

5 sites across 1 country: India