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COMPLETEDPHASE2

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.

NCT05008393•Hospital do Coracao

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult patients (age ≥ 18 years);
•2. COVID-19 diagnosis confirmed by:
•1. Detection of SARS-CoV-2 by reverse transcription polymerase chain reaction (RT-PCR), or
•2. Rapid genetic or antigen tests validated by Brazilian National Health Surveillance Agency (ANVISA);
•3. Mild or moderate symptoms without indication for hospitalization;
•4. Symptoms started seven days ago or less;
•5. Be able to access the study's online questionnaire.

Exclusion Criteria

•1. Pregnant or lactating women;
•2. Known allergy or hypersensitivity to the study drug;
•3. Patients at high risk of bleeding, defined by:
•1. Previous Intracranial hemorrhage,
•2. Ischemic stroke in the last 3 months,
•3. Anatomical vascular alteration of the central nervous system known, such as aneurysms or arteriovenous malformations,
•4. Malignant neoplasm of the central nervous system known,
•5. Metastatic solid neoplasia,
•6. Significant closed head or facial trauma in the last 3 months (defined as any trauma that required medical evaluation or hospitalization),
•7. Known intracranial abnormalities not listed as absolute contraindications (e.g., benign intracranial tumor),
+9 more criteria

Locations (1)

Hospital do Coracao

São Paulo, São Paulo, Brazil

Key Dates

Start Date

September 25, 2021

Primary Completion Date

February 3, 2022

Completion Date

March 4, 2022

Last Updated

April 12, 2022

Enrollment

153

ACTUAL participants

Conditions

Covid19COVID-19 Pneumonia

Interventions

PJS-539 Dose 1

DRUG

PJS-539 Dose 2

DRUG

Placebo

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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