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

Covid19 Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008393
• Other study ID #: IP-HCOR/PJS-539
• Secondary ID: Phase2_PJS-539
• Status: Completed
• Phase: Phase 2
• Start date: September 25, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: February 2022
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: March 4, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Covid19

Intervention

Drug:
• PJS-539 Dose 1
Patients will receive PJS-539 dose 1 daily for 10 days.
• PJS-539 Dose 2
Patients will receive PJS-539 Dose 2 daily for 10 days.
• Placebo
Patients will receive placebo daily for 10 days.

Locations

Country	Name	City	State
Brazil	Hospital do Coracao	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Covicept

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At day 10
Secondary	Hospital admission	Need for hospital admission.	Day 28
Secondary	Need for invasive mechanical ventilation	Intubation and initiation of mechanical ventilation for any given reason	Day 28
Secondary	Time to symptoms resolution	Time from randomization to symptoms resolution	Day 10
Secondary	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.	Day 14
Secondary	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	Up to 28 days
Secondary	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.	Up to 28 days