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

NCT ID: NCT05008393

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-25
• Study Completion Date: 2022-03-04

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.

Conditions

Covid19; COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Patients will receive placebo orally once daily for 10 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will receive placebo daily for 10 days.

PJS-539 Dose 1

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

Group Type: EXPERIMENTAL

PJS-539 Dose 1

Intervention Type: DRUG

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

PJS-539 Dose 2

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

Group Type: EXPERIMENTAL

PJS-539 Dose 2

Intervention Type: DRUG

Patients will receive PJS-539 Dose 2 daily for 10 days.

Interventions

PJS-539 Dose 1

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

Intervention Type: DRUG

PJS-539 Dose 2

Patients will receive PJS-539 Dose 2 daily for 10 days.

Intervention Type: DRUG

Placebo

Patients will receive placebo daily for 10 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covicept

UNKNOWN

Sponsor Role: collaborator

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Tomazini, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

Alexandre Biasi Cavalcanti, MD, PhD

Role: STUDY_DIRECTOR

Hospital do Coracao

Locations

Hospital do Coracao

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Phase2_PJS-539

Identifier Type: OTHER

Identifier Source: secondary_id

IP-HCOR/PJS-539

Identifier Type: -

Identifier Source: org_study_id