Page 46 - JCTR-10-1

Journal of Clinical and Translational Research 2024; 10(1): 33-51

Journal of Clinical and Translational Research

Journal homepage: http://www.jctres.com/en/home

ORIGINAL ARTICLE

Effect of combination of molnupiravir with clarithromycin on blood

biomarkers in patients with mild-to-moderate COVID-19

Supplementary File with SARS-CoV-2, and the amount of oxygen has not
been increased since the onset of symptoms of infection
Supplementary Data 1 with SARS-CoV-2)
Main inclusion/exclusion criteria for the global phase III study b. Requiring oxygen administration of 4 L/min or less due
[MOVe-OUT (002) study] to infection by SARS-CoV-2 regardless of SpO .
2
1. SARS-CoV-2-positive patients (confirmed by PCR test, etc. C. None of the following are recognized
using samples collected within 5 days before randomization). Shortness of breath at rest or incomplete breathing (when one
2. SARS-CoV-2 infection symptom onset within 5 days and 1 or more of the following (1) to (4) is required: (1) endotracheal
or more symptoms associated with SARS-CoV-2 infection intubation and ventilator, (2) high-flow oxygen therapy using
can be recognized (cough, sore throat, nasal congestion, nasal cannula [flow rate over 20 L/min, oxygen ratio of 0.5
runny nose, shortness of breath or difficulty breathing during or more], (3) non-invasive positive pressure ventilation, (4)
exertion, muscle or body pain, fatigue, fever [above 38.0℃], ECMO, shock state, multi-organ dysfunction)
chills, headache, nausea, vomiting, diarrhea, loss of sense of 4. Have one or more of the following risk factors for severe
smell, and loss of taste). SARS-CoV-2 infection:
3. Mild or moderate patient as defined below. (1) 61 years old or older active cancers (excludes cancers that
[Mild] Satisfy A and B do not involve immunosuppression or high mortality)
A. All of the following are recognized. (2) Chronic kidney disease
Breathing rate is <20 breaths/min, heart rate is less than (3) Chronic obstructive pulmonary disease
2
90 times/min, SpO is more than 93% (value in indoor (4) Obesity (BMI 30 kg/m more)
2
air or in a state where oxygen is administered for reasons (5) Serious heart disease (incomplete heart, coronary artery
other than infection with SARS-CoV-2 and the amount disease, or cardiomyopathy)
of oxygen has not been increased since the onset of (6) Diabetes
symptoms of infection with SARS-CoV-2) Molnupiravir has been evaluated in phase I, phase II, and
B. Neither of the following are recognized. phase III trials that have demonstrated favorable efficacy,
Shortness of breath at rest or during exertion or incomplete dose-dependent pharmacokinetics, and a robust safety
breathing (when one or more of the following (1) to (4) is profile. In an interim analysis of a phase III trial, treatment
required: (1) endotracheal intubation and ventilator, (2) with molnupiravir reduced the risk of hospitalization or death
high-flow oxygen therapy using nasal cannula [flow rate in COVID-19 patients by 50% [1]. On December 24, 2021,
over 20 L/min, oxygen ratio of 0.5 or more], (3) non- the Japanese Ministry of Health, Labor and Welfare granted
invasive positive pressure ventilation, (4) ECMO, shock special approval for domestic marketing of molnupiravir, an
state, multi-organ dysfunction) oral antiviral drug for COVID-19, based on the evaluation
[Moderate disease] Satisfy all of A to B in the phase III trial. Molnupiravir can be administered
A. One or more of the following is recognized to non-hospitalized patients aged 18 years and older with
Shortness of breath during exertion, respiratory rate is more mild-to-moderate disease who have risk factors for severe
than 20 times/min but less than 30 times/min, heart rate of 90 disease [2]. For the use of molnupiravir, we referred to the
beats/min or more and less than 125 beats/min guidelines from the World Health Organization (WHO) [3],
B. Any of the following is recognized Food and Drug Administration (FDA) [4], and National
a. SpO is over 93% (value in indoor air or in a state where Institutes of Health (NIH) [5].
2
oxygen is administered for reasons other than infection 1. Santani BG, LeBlanc BW, Thakare RP. Molnupiravir
DOI: https://doi.org/10.36922/jctr.00075