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

Primary Purpose

Covid19, COVID-19 Pneumonia

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
PJS-539 Dose 1
PJS-539 Dose 2
Placebo
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Antiviral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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),
    8. Bleeding in the last 2 to 4 weeks (excluding menstrual bleeding),
    9. Surgical procedure in the last 3 weeks,
    10. Current use of full-dose anticoagulants (warfarin, enoxaparin or new anticoagulants) or dual antiplatelet therapy,
    11. Thrombocytopenia (<100,000/mL) or international normalized ratio (INR) > 1.3;
  4. Renal failure, defined as glomerular filtration rate (GFR) estimated by the formulas Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <30 mL/min/1.73m2;
  5. Previous participation in the study;
  6. History of liver disease (cirrhosis) reported by the patient or in medical records, presence of esophageal varices or presence of ascites;
  7. Decompensated heart failure, defined by the presence of dyspnea attributed to cardiac cause, edema of the lower limbs, crackles on pulmonary auscultation or pathological jugular turgency.
  8. Participation in other clinical trials with antivirals in COVID-19

Sites / Locations

  • Hospital do Coracao

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

PJS-539 Dose 1

PJS-539 Dose 2

Arm Description

Patients will receive placebo orally once daily for 10 days.

Patients will receive PJS-539 dose 1 orally once daily for 10 days.

Patients will receive PJS-539 dose 2 orally once daily for 10 days.

Outcomes

Primary Outcome Measures

Decay rate of the SARS-CoV-2 viral load.
Decay rate of the SARS-CoV-2 viral load logarithmic curve obtained via nasopharyngeal swab between the baseline and the fifth and tenth days after randomization.

Secondary Outcome Measures

Hospital admission
Need for hospital admission.
Need for invasive mechanical ventilation
Intubation and initiation of mechanical ventilation for any given reason
Time to symptoms resolution
Time from randomization to symptoms resolution
Ordinal clinical scale of symptoms
Evaluation of the clinical scale of symptoms, which ranges from 1 to 7 as follows: 1. not hospitalized, without limitation of daily activities; 2. not hospitalized, with limitation of daily activities; 3. hospitalized, without the need for supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5 hospitalized, requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both; 6. hospitalized, requiring blood oxygenation through a membrane system, invasive mechanical ventilation, or both; 7. Death.
Adverse events
Grade 1, 2, 3 and 4 adverse events, which were not present at the patient's entrance, defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events
Bleeding
Defines as: Major: Defined as clinical bleeding associated with any of the following: fatal outcome, critical site involvement (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartmental or retroperitoneal syndrome), or clinical bleeding with a drop in hemoglobin concentration ≥2g/dL, or need for transfusion of ≥2 units of packed red blood cells or whole blood. All intracerebral (or intraparenchymal) bleeds are included in the primary analysis as hemorrhagic stroke. Clinically relevant non-major: Defined as clinical bleeding that does not present major bleeding criteria, but requires medical intervention, unscheduled contact (in person or by telephone) with a doctor, temporary interruption of the study drug, pain or impairment of daily activities. Minor: Defined as clinical bleeding that does not meet criteria for clinically relevant major or non-major bleeding.

Full Information

First Posted
August 16, 2021
Last Updated
April 11, 2022
Sponsor
Hospital do Coracao
Collaborators
Covicept
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1. Study Identification

Unique Protocol Identification Number
NCT05008393
Brief Title
Efficacy of PJS-539 for Adult Patients With COVID-19.
Acronym
PJS-539
Official Title
Efficacy of PJS-539 for Adult Patients With SARS-CoV-2: Multicentre, Phase 2, Randomized, Double-blind, Placebo-controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2021 (Actual)
Primary Completion Date
February 3, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
Collaborators
Covicept

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, COVID-19 Pneumonia
Keywords
COVID-19, Antiviral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized at a 1: 1: 1 ratio to each of the treatment groups.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The placebo used in this study will consist of the diluent solution used in the interventional drug preparation, which has the same physical characteristics as the interventional drug preparation. All the solutions will be prepared at a central pharmacy and will be sent to each site center in specific boxes containing the necessary regulatory information. The solutions for each study arm will be identified by a random letter from A to I (three letters each arm).
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo orally once daily for 10 days.
Arm Title
PJS-539 Dose 1
Arm Type
Experimental
Arm Description
Patients will receive PJS-539 dose 1 orally once daily for 10 days.
Arm Title
PJS-539 Dose 2
Arm Type
Experimental
Arm Description
Patients will receive PJS-539 dose 2 orally once daily for 10 days.
Intervention Type
Drug
Intervention Name(s)
PJS-539 Dose 1
Intervention Description
Patients will receive PJS-539 dose 1 daily for 10 days.
Intervention Type
Drug
Intervention Name(s)
PJS-539 Dose 2
Intervention Description
Patients will receive PJS-539 Dose 2 daily for 10 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo daily for 10 days.
Primary Outcome Measure Information:
Title
Decay rate of the SARS-CoV-2 viral load.
Description
Decay rate of the SARS-CoV-2 viral load logarithmic curve obtained via nasopharyngeal swab between the baseline and the fifth and tenth days after randomization.
Time Frame
At day 10
Secondary Outcome Measure Information:
Title
Hospital admission
Description
Need for hospital admission.
Time Frame
Day 28
Title
Need for invasive mechanical ventilation
Description
Intubation and initiation of mechanical ventilation for any given reason
Time Frame
Day 28
Title
Time to symptoms resolution
Description
Time from randomization to symptoms resolution
Time Frame
Day 10
Title
Ordinal clinical scale of symptoms
Description
Evaluation of the clinical scale of symptoms, which ranges from 1 to 7 as follows: 1. not hospitalized, without limitation of daily activities; 2. not hospitalized, with limitation of daily activities; 3. hospitalized, without the need for supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5 hospitalized, requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both; 6. hospitalized, requiring blood oxygenation through a membrane system, invasive mechanical ventilation, or both; 7. Death.
Time Frame
Day 14
Title
Adverse events
Description
Grade 1, 2, 3 and 4 adverse events, which were not present at the patient's entrance, defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events
Time Frame
Up to 28 days
Title
Bleeding
Description
Defines as: Major: Defined as clinical bleeding associated with any of the following: fatal outcome, critical site involvement (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartmental or retroperitoneal syndrome), or clinical bleeding with a drop in hemoglobin concentration ≥2g/dL, or need for transfusion of ≥2 units of packed red blood cells or whole blood. All intracerebral (or intraparenchymal) bleeds are included in the primary analysis as hemorrhagic stroke. Clinically relevant non-major: Defined as clinical bleeding that does not present major bleeding criteria, but requires medical intervention, unscheduled contact (in person or by telephone) with a doctor, temporary interruption of the study drug, pain or impairment of daily activities. Minor: Defined as clinical bleeding that does not meet criteria for clinically relevant major or non-major bleeding.
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (age ≥ 18 years); COVID-19 diagnosis confirmed by: Detection of SARS-CoV-2 by reverse transcription polymerase chain reaction (RT-PCR), or Rapid genetic or antigen tests validated by Brazilian National Health Surveillance Agency (ANVISA); Mild or moderate symptoms without indication for hospitalization; Symptoms started seven days ago or less; Be able to access the study's online questionnaire. Exclusion Criteria: Pregnant or lactating women; Known allergy or hypersensitivity to the study drug; Patients at high risk of bleeding, defined by: Previous Intracranial hemorrhage, Ischemic stroke in the last 3 months, Anatomical vascular alteration of the central nervous system known, such as aneurysms or arteriovenous malformations, Malignant neoplasm of the central nervous system known, Metastatic solid neoplasia, Significant closed head or facial trauma in the last 3 months (defined as any trauma that required medical evaluation or hospitalization), Known intracranial abnormalities not listed as absolute contraindications (e.g., benign intracranial tumor), Bleeding in the last 2 to 4 weeks (excluding menstrual bleeding), Surgical procedure in the last 3 weeks, Current use of full-dose anticoagulants (warfarin, enoxaparin or new anticoagulants) or dual antiplatelet therapy, Thrombocytopenia (<100,000/mL) or international normalized ratio (INR) > 1.3; Renal failure, defined as glomerular filtration rate (GFR) estimated by the formulas Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <30 mL/min/1.73m2; Previous participation in the study; History of liver disease (cirrhosis) reported by the patient or in medical records, presence of esophageal varices or presence of ascites; Decompensated heart failure, defined by the presence of dyspnea attributed to cardiac cause, edema of the lower limbs, crackles on pulmonary auscultation or pathological jugular turgency. Participation in other clinical trials with antivirals in COVID-19
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Tomazini, MD
Organizational Affiliation
Hospital do Coracao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandre Biasi Cavalcanti, MD, PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Director
Facility Information:
Facility Name
Hospital do Coracao
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04005-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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