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

Sponsor

Sichuan Huiyang Life Science and Technology Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05485584

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 SARS-CoV-2 Infection	Drug: rSIFN-co Nasal Spray Drug: rSIFN-co Nasal Spray Drug: Placebo Nasal Spray Drug: Placebo Nasal Spray	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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
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
Experimental: COVID-19 subjects(B1) Each nostril: 2 sprays/time; Pharynx: 4 sprays/time; Twice daily	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 Twice daily Other Names: ingredients

Outcome Measures

Primary Outcome Measures

Incidence of laboratory-confirmed SARS-CoV-2 infection in health subjects [Day1-Day28]
Incidence of laboratory-confirmed SARS-CoV-2 infection in health subjects over 28 days (Day 1 to Day 28) as assessed by RT-PCR
Percentage of subjects with disease progression [Day1-Day28]
Percentage of subjects with disease progression, defined as progression from asymptomatic/mild to moderate/severe in severity, over 28 days

Secondary Outcome Measures

To assess the safety and tolerability profiles of rSIFN-co nasal spray, as assessed by treatment-emergent adverse events (TEAEs) [Day1-Day28]
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.
Percentage of subjects discontinuing from study product due to TEAE during the treatment period [Day1-Day10]
All AEs will be assessed by the Investigator using the CTCAE version 5.0.
Percentage of subjects who develop to moderate or severe COVID-19 (WHO definition) over 28 days [Day1-Day28]
For healthy subjects only
Incidence of COVID-19-related complications over 28 days [Day1-Day28]
For healthy subjects only
Time to clearance of SARS-CoV-2 [Day1-Day28]
For COVID-19 subjects only. It defined as 2 consecutive negative swabs (sampling interval ≥24 hours)
Percentage of subjects who require supplemental oxygen or mechanical ventilation [Day1-Day28]
For COVID-19 subjects only.
Percentage of subjects with clinical improvement [Day1-Day10]
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 to clinical improvement from the highest outcome scores per 11-point WHO clinical progression scale [Day1-Day28]
For COVID-19 subjects only.
Time to resolution of all symptoms present at baseline [Day1-Day28]
For COVID-19 subjects only.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

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,

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.

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.

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	GreenCity Medical Center	San Fernando	Central Luzon	Philippines
2	Medical Center Manila	Manila		Philippines
3	Srinagarind Hospital	Khon Kaen	Changwat Khon Kaen	Thailand
4	Songklanagarind Hospital	Songkhla	Changwat Songkhla	Thailand

Sponsors and Collaborators

Sichuan Huiyang Life Science and Technology Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sichuan Huiyang Life Science and Technology Corporation

ClinicalTrials.gov Identifier:

NCT05485584

Other Study ID Numbers:

SHL-rSIFN-002

First Posted:

Aug 3, 2022

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 17, 2022