Clinical trial NCT05008393: Efficacy of PJS-539 for Adult Patients With COVID-19.
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
COVID-19 Pneumonia
Keywords: COVID-19
Antiviral
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Covicept
First posted: 2021-08-17
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized at a 1: 1: 1 ratio to each of the treatment groups.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decay rate of the SARS-CoV-2 viral load.
timeFrame: At day 10
Secondary outcomes:
measure: Hospital admission
timeFrame: Day 28
measure: Need for invasive mechanical ventilation
timeFrame: Day 28
measure: Time to symptoms resolution
timeFrame: Day 10
measure: Ordinal clinical scale of symptoms
timeFrame: Day 14
measure: Adverse events
timeFrame: Up to 28 days
measure: Bleeding
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
state: SP
Study officials:
affiliation: Hospital do Coracao
name: Bruno Tomazini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coracao
name: Alexandre Biasi Cavalcanti, MD, PhD
role: STUDY_DIRECTOR
References: