Japanease

July. 21, 2020

Aug. 31, 2020

jRCT2071200023

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 Hospital

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

+81-95-819-7273

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

July. 22, 2020

120

Interventional

randomized controlled trial

open(masking not used)

no treatment control

parallel assignment

treatment purpose

none

(1) Japanese male or female patients aged 20 or above at the time of informed consent
(2) Patients who had SARS-CoV-2 detected from upper and lower respiratory specimens by PCR or LAMP testing within 3 days before informed consent
(3) Patients who have been given full explanation about the contents of the informed consent form and other study-related details, understood the study content, and voluntarily signed the informed consent to participate in the study

(1) Patients whose symptoms developed 8 or more days prior to enrollment
(2) Patients whose SpO2 is <96% (room air)
(3) Patients who meet any of the following screening test criteria:
1) ALT or AST levels exceed five times the upper limit of the reference range.
2) Child-Pugh class B or C.
3) Serum creatinine levels exceed twice the upper limit of the reference range, and creatinine clearance levels are <30 mL/min. (Estimated creatinine clearance levels by the Cockcroft-Gault formula. However, actual measurement values will be used when available.)
(4) Patients with poorly controlled diabetes (a casual blood glucose level of >=200 mg/dL or HbA1c of >=7.0% despite receiving diabetes treatment)
(5) Patients with serious complications who are deemed unsuitable for inclusion in the clinical 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 symptoms
(8) Patients with a previous history of hypersensitivity to the ingredients of the investigational drug
(9) Female patients who are breastfeeding, pregnant, or female patients of childbearing potential
(10) Patients who cannot use proper 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 informed consent
(12) Patients who participated in other clinical trials/studies and received drugs within 12 weeks prior to informed consent
(13) Patients undergoing treatment for HIV infection
(14) Other patients who for other reasons are deemed inappropriate for inclusion in the clinical trial based on the assessment by either the principal or sub-investigator

20age old over
No limit

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 (AUC) of viral load: Viral load measured by real-time PCR assay using saliva samples up to day 28 will be evaluated
(2) Half decay period of viral load: Viral load measured by real-time PCR assay using saliva samples up to day 28
(3) Body temperature at each time point
(4) All-cause mortality: The number of deaths by all causes in 28 days following enrollment will be evaluated
(5) Incidence rate of pneumonia: The number of days until newly developed pneumonia due to COVID-19 (incidence per day) from enrollment will be evaluated
(6) Percentage of newly developed pneumonia patients: The number of patients with newly developed pneumonia due to COVID-19 by day 28 will be evaluated
(7) Oxygen administration rate: The number of days from enrollment until the start of (continuous oxygen administration for 24 h or longer) will be evaluated
(8) Percentage of patients administered oxygen: The number of subjects started of (continuous oxygen administration for 24 h or longer) in the 28 days following enrollment will be evaluated
<For asymptomatic patients>
(1) Incidence of symptomatic COVID-19: The number of subjects developed any COVID-19-related symptoms, including (fever of 37.0 degree C or above) and (cough persisting for 24 h or longer) will be evaluated
(2) Incidence of patients with a fever: The number of subjects developed a (fever of 37.0 degree C or above for two consecutive days) in the 28 days following enrollment will be evaluated
(3) Incidence of coughing patients: The number of subjects a (cough persisting for 24 h or longer) in the 28 days following enrollment will be evaluated
<For mild patients>
(1) Incidence of defervescence: The number of days from enrollment until the day on which body temperature returned to the level below 37.0 degree C will be evaluated
(2) Recovery incidence of clinical symptom: The number of days until all COVID-19-related symptoms disappear will be evaluated
(3) Improvement incidence for each symptom: The number of days until each COVID-19-related symptom ameliorates (evaluated by symptom content) will be evaluated
(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)

Recruiting

Health and Labor Sciences Research Grant
Not applicable
Institutional Review Board, Nagasaki University Hospital
1-7-1 Sakamoto, Nagasaki, Nagasaki

Approval

May. 25, 2020