PROspective study of Treatment with Ensitrelvir for Covid-19 in paTients undergoing HemoDialysis

JRCT ID: jRCTs071240069

Registered date:15/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 15/10/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Encytrelvir is administered 375 mg (125 mg x 3 tablets) once daily on day 1 and 125 mg (125 mg x 1 tablet) once daily from day 2 to day 5.

Outcome(s)

Primary Outcome

1) Ensitrelvir concentration in plasma
2) Ensitrelvir dosage in dialysis recovery fluid and dialysis clearance

Secondary Outcome

1) Clinical efficacy of ensitrelvir at Visit 4
2) Time to recovery to normal body temperature (<37.0) (h)
3) Change from baseline in viral titer of SARS-CoV-2 at Visit 4
4) Change from baseline in SARS-CoV-2 viral RNA levels at Visit 4

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Criteria for obtaining consent
(1) Patients who are able to obtain written consent for study participation of their own free will
(2) Patients who are 18 years old or older
(3) Patients with a body weight (dry weight) of 40 kg or more
(4) Patients who have undergone hemodialysis at least once a week for at least 12 weeks and are scheduled to undergo hemodialysis during Visit 2 (Day 2 to Day 4)
(5) Women of childbearing potential who are able to use adequate contraception with their partners if they have sexual intercourse during the period of study drug administration and within 2 weeks after the last dose.
Criteria for case enrollment and administration of research drug
(6) Patients diagnosed with COVID-19 by nucleic acid amplification (PCR, LAMP, etc.), antigen test (qualitative, quantitative)
(7) Patients with mild disease classified by the severity classification in the Guide to the Diagnosis and Treatment of COVID-19(Edition 10.1).(Severity: mild disease, oxygen saturation: SpO2 >= 96%, clinical condition: no respiratory symptoms or cough only, no dyspnea, no evidence of pneumonia)
(8) Patients who can receive research drug within 72 hours of COVID-19 onset

Exclude criteria

1) Patients who, are strongly suspected to have worsening symptoms of SARS-CoV-2 infection within 48 hours after obtaining consent
2) Patients with suspected active bacterial, fungal, or a other viral infection requiring treatment at the time of consent
3) Patients who have an FDL catheter (Flexible double lumen catheter) or long-term indwelling catheter for hemodialysis
4) Patients with severe liver dysfunction (Child Pugh C level)
5) Women who are pregnant or may be pregnant
6) Women who are giving breast-feeding
7) Patients with immunodeficient status.
8) Patients who have used the following drugs within 14 days prior to the consent
-Treatment agents approved for SARS-CoV-2 infection
-Drugs that have been reported to potentially act against SARS-CoV-2 (plasma of convalescent patients, ivermectin, fabipiravir, etc.)
9) Patients with drug abuse
10) Patients with a history of hypersensitivity or allergy to ensitrelvir or its components
11) Patients who are receiving or are scheduled to receive the drug contraindicated with ensitrelvir during the period of ensitrelvir administration.
12) Patients who have used CYP3A inducers that are contraindicated with ensitrelvir within 14 days prior to obtaining consent
-Apalutamide (Arlida)
-Carbamazepine (Tegretol)
-Enzalutamide (Ixtanzi)
-Mitotane (Opeprim)
-Phenytoin (Hydantol, Aleviatin)
-Fosphenytoin sodium hydrate (Hostin)
-Rifampicin (Rifadin)
-Food products containing St. John's wort (St. John's wort)
13) Patients unable to swallow ensitrelvir
14) Patients who are participating in other interventional studies or have participated in this study
15) Patients who have participated in a clinical trial of a drug within the past year and have taken an investigational drug.
16) Patients who are deemed inappropriate as research subjects for other reasons by the principal investigator or sub investigator.

Related Information

• Primary Sponsor: Mukae Hiroshi
• Secondary Sponsor: Shionogi & Co., Ltd.