JPRN-jRCT2071200023CompletedPhase 1
Evaluation of Nelfinavir for asymptomatic and mild COVID-19: A multicenter open-label, blinded outcome, randomized controlled trial - NFV trial for asymptomatic and mild COVID-19
Miyazaki Taiga0 sites120 target enrollmentStarted: July 21, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •(1) Japanese male or female patients aged 20 or above at the time of obtaining informed consent
- •(2) Patients in which SARS-CoV-2 was detected from the upper and lower respiratory tract specimens using polymerase chain reaction (PCR) or loop-mediated isothermal amplification, or those who were positive for the antigen at least 3 days before obtaining the informed consent.
- •(3) Patients who have been provided with complete information about the contents of the informed consent form and other study-related details, and who voluntarily sign the informed consent form to participate in the study after having understood the study content.
Exclusion Criteria
- •(1) Patients who develop symptoms 8 or more days prior to enrollment
- •(2) Patients with an SpO2 < 96 % (room air)
- •(3) Patients who meet any of the following screening criteria:
- •a) Alanine aminotransferase or aspartate aminotransferase levels five times higher than the upper limit of the reference range.
- •b) Child Pugh class B or C.
- •c) Serum creatinine levels two times higher than the upper limit of the reference range, and creatinine clearance is < 30 mL/min (Estimated Creatinine clearance using the Cockcroft Gault formula. However, actually measured values will be used if available).
- •(4) Patients with poorly controlled diabetes (random blood glucose >= 200 mg/dL or HbA1c >= 7.0 % despite treatment).
- •(5) Patients with serious complications who are deemed unsuitable for inclusion in the study based on the assessment by either the principal investigator or the sub-investigator.
- •(6) Hemophilic patients or patients with a marked hemorrhagic tendency
- •(7) Patients with severe diarrhea
- •(8) Patients with a history of hypersensitivity to the ingredients of the investigational drug.
- •(9) Female patients who are breastfeeding, pregnant, or of childbearing potential.
- •(10) Patients who refused to adopt contraceptive methods during the study period from the initial administration of the investigational drug (male patients, and female patients of childbearing potential).
- •(11) Patients who were receiving rifampicin within 2 weeks prior to obtaining informed consent.
- •(12) Patients who participated in other clinical trials and received drugs within 12 weeks prior to obtaining informed consent.
- •(13) Patients undergoing treatment for HIV infection
- •(14) Patients who have been vaccinated against COVID-19, or wish to be vaccinated against COVID-19 while participating in the clinical trial
- •(15) Other patients who are deemed inappropriate (miscellaneous reasons) for inclusion in the clinical trial based on the assessment by either the principal investigator or the sub investigator.
Investigators
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