臨床研究等提出・公開システム

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)

Evaluation of Nelfinavir for asymptomatic and mild COVID-19 (Evaluation of Nelfinavir for asymptomatic and mild COVID-19)

Miyazaki Taiga

Nagasaki University

1-7-1 Sakamoto, Nagasaki, 852-8501, Japan

taiga-m@nagasaki-u.ac.jp

Hosogaya Naoki

Nagasaki University Hospital

1-7-1 Sakamoto Nagasaki, 852-8501, Japan

+81-95-819-7726

nhosogaya@nagasaki-u.ac.jp

Complete

July. 22, 2020

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

(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.

(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.

Both

Asymptomatic and mild COVID-19

Nelfinavir group: 750 mg of nelfinavir is orally administered to each subject, three times daily, for 14 days.
Symptomatic treatment group: symptomatic treatment

COVID-19

Time to negative conversion of SARS-CoV-2

(Efficacy endpoints)
<Common endpoints>
(1) Area under the curve of viral load: Viral load measured using real-time PCR assay of saliva samples until day 28.
(2) Half decay period of viral load: Viral load measured using real-time PCR assay of saliva samples until day 28
(3) Body temperature at each time point
Body temperature and clinical symptoms (such as cough, dyspnea, sputum, nasal discharge, nasal congestion, pharyngeal pain, malaise, headache, anorexia, diarrhea, nausea, vomiting, arthralgia, myalgia, dysgeusia, dysosmia) are collected by Symptom Diary.
(4) All-cause mortality: The number of deaths of all causes 28 days following the day of enrollment.
(5) Incidence rate of pneumonia: The number of days from the day of enrollment until newly developed pneumonia due to COVID-19 (incidence per day).
(6) Percentage of patients with newly developed pneumonia: The number of patients with newly developed pneumonia due to COVID-19 by day 28.
(7) Rate of oxygen administration: The number of days from the day of enrollment until the start of (continuous oxygen administration for 24 h or longer).
(8) Percentage of patients administered oxygen: The number of subjects started on (continuous oxygen administration for 24 h or longer) in the 28 days following the day of enrollment.
<For asymptomatic patients>
(1) Incidence of symptomatic COVID-19: The number of subjects that developed any symptoms of COVID-19, including (fever of 37.0 degree C or above) and (cough persisting for 24 h or longer).
(2) Incidence of fever: The number of subjects who developed a (fever of 37.0 degree C or above for two consecutive days) in the 28 days following the day of enrollment.
(3) Incidence of cough: The number of subjects who developed (cough persisting for 24 h or longer) in the 28 days following the day of enrollment.
<For mild patients>
(1) Incidence of defervescence: The number of days from the day of enrollment until the day on which body temperature returns to below 37.0 degree C.
(2) Incidence of recovery from clinical symptoms: The number of days from the day of enrollment until all the symptoms of COVID-19 disappear.
(3) Incidence of improvement of each symptom: The number of days from the day of enrollment until each symptom of COVID-19 ameliorates.
(Safety endpoints)
(1) Adverse events (incidence of adverse events, incidence of serious adverse events, incidence of adverse reactions, and incidence of serious adverse reactions)
(2) Clinical examinations (hematologic tests, blood biochemical tests, and vital signs)

+81-95-819-7229

May. 25, 2020

Yes

The datasets generated and/or analyzed during the current study will be available from the corresponding author upon reasonable request.

none