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

NCT05485584 | Completed Phase 2

• 1 other identifier: SHL-rSIFN-002
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19; SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Day1-Day28

Secondary Outcomes (9)

• To assess the safety and tolerability profiles of rSIFN-co nasal spray, as assessed by treatment-emergent adverse events (TEAEs)

  Day1-Day28

• Percentage of subjects discontinuing from study product due to TEAE during the treatment period

  Day1-Day10

• Percentage of subjects who develop to moderate or severe COVID-19 (WHO definition) over 28 days

  Day1-Day28

• Incidence of COVID-19-related complications over 28 days

  Day1-Day28

• Time to clearance of SARS-CoV-2

  Day1-Day28

Study Arms (4)

Healthy subjects(A1)

EXPERIMENTAL

Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Once daily

Drug: rSIFN-co Nasal Spray

Healthy subjects(A2)

PLACEBO COMPARATOR

Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Once daily

Drug: Placebo Nasal Spray

COVID-19 subjects(B1)

EXPERIMENTAL

Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Twice daily

Drug: rSIFN-co Nasal Spray

COVID-19 subjects(B2)

PLACEBO COMPARATOR

Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Twice daily

Drug: Placebo Nasal Spray

Interventions

rSIFN-co Nasal Spray DRUG

8 million IU (16 μg)/day; Once daily

Also known as: rSIFN-co

Healthy subjects(A1)

Placebo Nasal Spray DRUG

Once daily

Also known as: ingredients

Healthy subjects(A2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 and ≤75 years of age at the time of informed consent.
• Willing and able to provide written informed consent/assent for the trial.
• Healthy subjects in close contact with confirmed COVID-19 case(s) or subjects with mild or asymptomatic COVID-19.
• a. Healthy subjects in close contact with confirmed COVID-19 case(s) i. With exposure to confirmed COVID-19 case(s) within 96 hours (refer to the definition of healthy subjects in close contact with confirmed COVID-19 case\[s\]), ii. Negative reverse transcriptase-polymerase chain reaction (RT-PCR) test for SARS-CoV-2 infection, with the sample collected at screening, iii. Have no previous confirmed COVID-19 diagnosis, iv. Without symptoms of respiratory infection, including fever, cough, fatigue, anorexia, shortness of breath, myalgias, sore throat, nasal congestion, headache, gastrointestinal symptoms, loss of smell (anosmia), loss of taste (ageusia), or other symptoms associated with COVID-19, AND v. With stable health status, as judged by the investigator and determined by physical examination, vital signs, medical history, and laboratory tests at screening.
• b. Subjects with mild or asymptomatic COVID-19 i. Meeting the criteria of mild or asymptomatic COVID-19,
• Note:
• Asymptomatic or presymptomatic infection: Individuals who test positive for SARS-CoV-2 by virologic testing using a molecular diagnostic (e.g., PCR) or antigen test, but have no symptoms.
• Mild disease: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain) and saturation of oxygen (SpO2) ≥90% on room air at sea level, without shortness of breath, dyspnea, or abnormal chest imaging.
• ii. Positive RT-PCR test for SARS-CoV-2 infection, with the sample collected at screening or within 72 hours prior to screening, AND iii. Without evidence of viral pneumonia or hypoxia.
• Women of childbearing potential must have a negative pregnancy test result at screening.
• Males and females who are fertile must adhere to contraception requirements for the duration of the study.
• Non-participation in any other clinical trials during the study period.

You may not qualify if:

• Subjects with any of the following conditions that would impair their ability to participate reliably in the trial, or those who may increase the risk to themselves or others by participating
• Clinically significant laboratory abnormalities (including a screening test of aspartate aminotransferase/alanine aminotransferase (AST/ALT) \> 5 times the upper limit of normal \[ULN\] and/or estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m2)
• Serious medical illnesses (including known history of major hematological, renal, cardiovascular, or hepatic abnormalities that are clinically significant)
• Psychological condition or social circumstances
• Received an experimental medication within 1 month prior to screening or expect to receive such treatment during the study period.
• With contraindication or hypersensitivity to the study product or any of its component.
• Pregnant or lactating women.
• Unwilling or unable to follow protocol requirements.
• Any condition which in the investigator's opinion deems the potential participant an unsuitable candidate to receive the study product.
• Received any interferons and any nasal/pharyngeal sprays within 7 days prior to screening.
• Received COVID-19 vaccine within 14 days prior to screening
• Had previous confirmed SARS-CoV-2 infection \>96 hours prior to being screened for the study.

Sponsors & Collaborators

• Sichuan Huiyang Life Science and Technology Corporation: lead

Study Sites (2)

GreenCity Medical Center

San Fernando City, Central Luzon, Philippines

Location

Medical Center Manila

Manila, Philippines

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GW WEI

  Sichuan Huiyang Life Science and Technology Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: August 3, 2022
• Study Start: July 1, 2022
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: February 25, 2025

Record last verified: 2024-04

Locations

PH (2)