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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; SARS-CoV-2 Infection
• Intervention / Treatment: Drug: rSIFN-co Nasal Spray; Drug: rSIFN-co Nasal Spray; Drug: Placebo Nasal Spray; Drug: Placebo Nasal Spray

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 2

Contacts and Locations

Study Locations

• Philippines
  • Manila, Philippines
    • Medical Center Manila
  • Central Luzon
    • San Fernando, Central Luzon, Philippines
      • GreenCity Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female ≥18 and ≤75 years of age at the time of informed consent.
2. Willing and able to provide written informed consent/assent for the trial.

3. 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.

4. Women of childbearing potential must have a negative pregnancy test result at screening.
5. Males and females who are fertile must adhere to contraception requirements for the duration of the study.
6. Non-participation in any other clinical trials during the study period.

Exclusion Criteria:

1. 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

   1. 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)
   2. Serious medical illnesses (including known history of major hematological, renal, cardiovascular, or hepatic abnormalities that are clinically significant)
   3. Psychological condition or social circumstances
2. Received an experimental medication within 1 month prior to screening or expect to receive such treatment during the study period.
3. With contraindication or hypersensitivity to the study product or any of its component.
4. Pregnant or lactating women.
5. Unwilling or unable to follow protocol requirements.
6. Any condition which in the investigator's opinion deems the potential participant an unsuitable candidate to receive the study product.
7. Received any interferons and any nasal/pharyngeal sprays within 7 days prior to screening.
8. Received COVID-19 vaccine within 14 days prior to screening
9. Had previous confirmed SARS-CoV-2 infection >96 hours prior to being screened for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subjects(A1); Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Once daily	Drug: rSIFN-co Nasal Spray; 8 million IU (16 μg)/day; Once daily; Other Names: rSIFN-co; Drug: rSIFN-co Nasal Spray; 16 million IU (32 μg)/day; Twice daily; Other Names: rSIFN-co
Placebo Comparator: Healthy subjects(A2); Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Once daily	Drug: Placebo Nasal Spray; Once daily; Other Names: ingredients; Drug: Placebo Nasal Spray; Twice daily; Other Names: ingredients
Experimental: COVID-19 subjects(B1); Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Twice daily	Drug: rSIFN-co Nasal Spray; 8 million IU (16 μg)/day; Once daily; Other Names: rSIFN-co; Drug: rSIFN-co Nasal Spray; 16 million IU (32 μg)/day; Twice daily; Other Names: rSIFN-co
Placebo Comparator: COVID-19 subjects(B2); Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Twice daily	Drug: Placebo Nasal Spray; Once daily; Other Names: ingredients; Drug: Placebo Nasal Spray; Twice daily; Other Names: ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day1-Day10
Percentage of subjects who develop to moderate or severe COVID-19 (WHO definition) over 28 days	For healthy subjects only	Day1-Day28
Incidence of COVID-19-related complications over 28 days	For healthy subjects only	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)	Day1-Day28
Percentage of subjects who require supplemental oxygen or mechanical ventilation	For COVID-19 subjects only.	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	Day1-Day10
Time to clinical improvement from the highest outcome scores per 11-point WHO clinical progression scale	For COVID-19 subjects only.	Day1-Day28
Time to resolution of all symptoms present at baseline	For COVID-19 subjects only.	Day1-Day28

Collaborators and Investigators

• Sponsor: Sichuan Huiyang Life Science and Technology Corporation
• Investigators: Study Director: GW WEI, Sichuan Huiyang Life Science and Technology Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): April 5, 2023
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SHL-rSIFN-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No