NCT05008393

Efficacy of PJS-539 for Adult Patients With COVID-19.

Efficacy of PJS-539 for Adult Patients With SARS-CoV-2: Multicentre, Phase 2, Randomized, Double-blind, Placebo-controlled Clinical Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PJS-539 is a multicentre, phase 2, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of PJS-539 in the viral load of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Detailed description

COVID-19, a disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a pandemic in March 2020. Clinically, the coronavirus disease 2019 (COVID-19) ranges from asymptomatic disease in some to severe forms. However, until now, only the use of corticosteroids in selected patients has been shown to improve clinical outcomes in patients with COVID-19. PJS-539 has been demonstrated to inhibit viral uptake and replication of SARS-CoV-2. The objective of this Phase II trial is to assess the effect of PJS-539 in the viral load of patients with mild to moderate COVID-19 symptoms.

Conditions

• Covid19
• COVID-19 Pneumonia

Interventions

Type	Name	Description
DRUG	PJS-539 Dose 1	Patients will receive PJS-539 dose 1 daily for 10 days.
DRUG	PJS-539 Dose 2	Patients will receive PJS-539 Dose 2 daily for 10 days.
DRUG	Placebo	Patients will receive placebo daily for 10 days.

Timeline

• Start date: 2021-09-25
• Primary completion: 2022-02-03
• Completion: 2022-03-04
• First posted: 2021-08-17
• Last updated: 2022-04-12

Locations

1 site across 1 country: Brazil