NCT05485584

rSIFN-co Among Healthy Subjects and Subjects With Mild or Asymptomatic COVID-19

An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase II Pilot Study to Evaluate the Efficacy and Safety of Recombinant Super-compound Interferon (rSIFN-co) Among Healthy Subjects in Close Contact With Confirmed COVID-19 Case(s) and Subjects With Mild or Asymptomatic COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Sichuan Huiyang Life Science and Technology Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	rSIFN-co Nasal Spray	8 million IU (16 μg)/day; Once daily
DRUG	rSIFN-co Nasal Spray	16 million IU (32 μg)/day; Twice daily
DRUG	Placebo Nasal Spray	Once daily
DRUG	Placebo Nasal Spray	Twice daily

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-04-05
• Completion: 2023-04-05
• First posted: 2022-08-03
• Last updated: 2025-02-25

Locations

2 sites across 1 country: Philippines