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

NCT05008393 | Completed Phase 2 DMC

• 2 other identifiers: IP-HCOR/PJS-539Phase2_PJS-539
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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).

Conditions

Covid19; COVID-19 Pneumonia

Keywords

COVID-19; Antiviral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Hospital admission

  Day 28

• Need for invasive mechanical ventilation

  Day 28

• Time to symptoms resolution

  Day 10

• Ordinal clinical scale of symptoms

  Day 14

• Adverse events

  Up to 28 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Patients will receive placebo orally once daily for 10 days.

Drug: Placebo

PJS-539 Dose 1

EXPERIMENTAL

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

Drug: PJS-539 Dose 1

PJS-539 Dose 2

EXPERIMENTAL

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

Drug: PJS-539 Dose 2

Interventions

PJS-539 Dose 1 DRUG

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

PJS-539 Dose 1

PJS-539 Dose 2 DRUG

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

PJS-539 Dose 2

Placebo DRUG

Patients will receive placebo daily for 10 days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital do Coracao: lead
• Covicept: collaborator

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, 04005-000, Brazil

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bruno Tomazini, MD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Alexandre Biasi Cavalcanti, MD, PhD

  Hospital do Coracao

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized at a 1: 1: 1 ratio to each of the treatment groups.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 17, 2021
• Study Start: September 25, 2021
• Primary Completion: February 3, 2022
• Study Completion: March 4, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)