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Covid19Phase 2PJS-539NCT05008393

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

A Phase 2 study testing PJS-539 Dose 1 and PJS-539 Dose 2 in people with Covid19 and COVID-19 Pneumonia, run by Hospital do Coracao at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, COVID-19 Pneumonia
What is being tested?
PJS-539 Dose 1 and PJS-539 Dose 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
1 siteBrazil
Study dates
25 Sep 2021to 4 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 19Show fewer
  • 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;
  • Previous participation in the study;
  • History of liver disease (cirrhosis) reported by the patient or in medical records, presence of esophageal varices or presence of ascites;
  • 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.
  • Participation in other clinical trials with antivirals in COVID-19

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital do Coracao

    São Paulo, São Paulo, 04005-000

Other trials in Brazil

About this study

Official title: Efficacy of PJS-539 for Adult Patients With SARS-CoV-2: Multicentre, Phase 2, Randomized, Double-blind, Placebo-controlled Clinical Trial.

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).

Read the 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.

Being tested
PJS-539 Dose 1, PJS-539 Dose 2, Placebo
Keywords
COVID-19, Antiviral
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PJS-539 Dose 1Drug

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

  • PJS-539 Dose 2Drug

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

  • PlaceboDrug

    Patients will receive placebo daily for 10 days.

Study groups in NCT05008393
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPatients will receive placebo orally once daily for 10 days.
Receives: Drug: Placebo
PJS-539 Dose 1ExperimentalPatients will receive PJS-539 dose 1 orally once daily for 10 days.
Receives: Drug: PJS-539 Dose 1
PJS-539 Dose 2ExperimentalPatients will receive PJS-539 dose 2 orally once daily for 10 days.
Receives: Drug: PJS-539 Dose 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At day 10

Secondary outcomes (6)

  1. Hospital admission

    Need for hospital admission.

    Measured: Day 28

  2. Need for invasive mechanical ventilation

    Intubation and initiation of mechanical ventilation for any given reason

    Measured: Day 28

  3. Time to symptoms resolution

    Time from randomization to symptoms resolution

    Measured: Day 10

  4. 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.

    Measured: Day 14

  5. 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

    Measured: Up to 28 days

  6. 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.

    Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start25 Sep 2021
  3. Primary completion3 Feb 2022
  4. Study completion4 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized at a 1: 1: 1 ratio to each of the treatment groups.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008393
Sponsor's protocol ID
IP-HCOR/PJS-539
Other IDs
Phase2_PJS-539
Acronym
PJS-539
Status last verified
Feb 2022
First submitted
16 Aug 2021
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tomazini BM, Tramujas L, Medrado FA Junior, Gomes SPDC, Negrelli KL, Murinize GS, Santos RHN, Vianna BMP, Piotto BF, Veiga TS, Santos BRD, Peneluppi Horak AC, Lemos OMC, Lopes MA, Olicheski BB, Campones DL, Peixoto LAA, Basilio ADAC, Gebara OCE, Lopes ATA, Saconato H, Valeis N, Miranda TA, Laranjeira LN, Santucci EV, Carlin AF, Esko JD, Gordts PLSM, Tsimikas S, Cavalcanti AB. Halofuginone for non-hospitalized adult patients with COVID-19 a multicenter, randomized placebo-controlled phase 2 trial. The HALOS trial. PLoS One. 2024 Feb 23;19(2):e0299197. doi: 10.1371/journal.pone.0299197. eCollection 2024.

    PubMed 38394069

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PJS-539 Dose 1 and PJS-539 Dose 2 in people with Covid19 and COVID-19 Pneumonia, run by Hospital do Coracao at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decay rate of the SARS-CoV-2 viral load. (time frame: At day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05008393, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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