This is a phase II pilot, international, multicenter, randomized, double-blind, placebo-controlled study that aims to evaluate the safety and preliminary efficacy of rSIFN-co nasal spray in healthy subjects in close contact with confirmed COVID-19 case(s) as well as subjects with mild or asymptomatic COVID-19.
Approximately 200 subjects are planned to be enrolled, including 100 healthy subjects and 100 COVID-19 subjects. For the healthy subjects in close contact with confirmed COVID-19 case(s) (Group A), approximately 100 subjects will be randomized in a 1:1 ratio to receive placebo or rSIFN-co treatment in a double-blind fashion. For the subjects with mild or asymptomatic COVID-19 (Group B), approximately 100 subjects will also be randomly assigned in a 1:1 ratio to receive institutional or local standard of care (SoC) plus placebo or SoC plus rSIFN-co in a double-blind fashion. All subjects will receive the study product for 10 days; around 8 million IU (16 μg) or 16 million IU (32 μg) of rSIFN-co will be administered daily. The safety and efficacy parameters will be monitored throughout the study period. Subjects will be instructed to complete a diary to record daily administration of study product, SpO2 level, as well as the occurrence and severity of any clinical symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
188
8 million IU (16 μg)/day; Once daily
16 million IU (32 μg)/day; Twice daily
Once daily
GreenCity Medical Center
San Fernando City, Central Luzon, Philippines
Medical Center Manila
Manila, Philippines
Incidence of laboratory-confirmed SARS-CoV-2 infection in health subjects
Incidence of laboratory-confirmed SARS-CoV-2 infection in health subjects over 28 days (Day 1 to Day 28) as assessed by RT-PCR
Time frame: Day1-Day28
Percentage of subjects with disease progression
Percentage of subjects with disease progression, defined as progression from asymptomatic/mild to moderate/severe in severity, over 28 days
Time frame: Day1-Day28
To assess the safety and tolerability profiles of rSIFN-co nasal spray, as assessed by treatment-emergent adverse events (TEAEs)
TEAEs will be coded using the Medical Dictionary for Drug Regulatory Affairs (MedDRA®, version 24.1 or later) and presented as summary tabulations, including categorical information of interest such as severity, causal relationship to study medication, and action taken.
Time frame: Day1-Day28
Percentage of subjects discontinuing from study product due to TEAE during the treatment period
All AEs will be assessed by the Investigator using the CTCAE version 5.0.
Time frame: Day1-Day10
Percentage of subjects who develop to moderate or severe COVID-19 (WHO definition) over 28 days
For healthy subjects only
Time frame: Day1-Day28
Incidence of COVID-19-related complications over 28 days
For healthy subjects only
Time frame: Day1-Day28
Time to clearance of SARS-CoV-2
For COVID-19 subjects only. It defined as 2 consecutive negative swabs (sampling interval ≥24 hours)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Twice daily
Time frame: Day1-Day28
Percentage of subjects who require supplemental oxygen or mechanical ventilation
For COVID-19 subjects only.
Time frame: Day1-Day28
Percentage of subjects with clinical improvement
For COVID-19 subjects only. It defined as a decrease of at least one point per the 11-point WHO clinical progression scale compared to baseline, on Days 5 and 10
Time frame: Day1-Day10
Time to clinical improvement from the highest outcome scores per 11-point WHO clinical progression scale
For COVID-19 subjects only.
Time frame: Day1-Day28
Time to resolution of all symptoms present at baseline
For COVID-19 subjects only.
Time frame: Day1-Day28