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).
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.
Drug: PJS-539 Dose 1
Patients will receive PJS-539 dose 1 daily for 10 days.
Drug: PJS-539 Dose 2
Patients will receive PJS-539 Dose 2 daily for 10 days.
Drug: Placebo
Patients will receive placebo daily for 10 days.
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
Hospital do Coracao
Sao Paulo, SP, Brazil