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COVID-19Phase 2NCT05485584

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

A Phase 2 study testing rSIFN-co Nasal Spray in people with COVID-19 and SARS-CoV-2 Infection, run by Sichuan Huiyang Life Science and Technology Corporation at 2 sites in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS-CoV-2 Infection
What is being tested?
rSIFN-co Nasal Spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
2 sitesPhilippines
Study dates
1 Jul 2022to 5 Apr 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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, 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.
  • Subjects with mild or asymptomatic COVID-19 i. Meeting the criteria of mild or asymptomatic COVID-19,
  • Note:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Philippines2 sites

  • Medical Center Manila

    Manila

  • GreenCity Medical Center

    San Fernando City, Central Luzon

Other trials in Philippines

About this study

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

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.

Read the 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.

Being tested
rSIFN-co Nasal Spray, Placebo Nasal Spray
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rSIFN-co Nasal SprayDrug

    Also called rSIFN-co

    8 million IU (16 μg)/day; Once daily

  • rSIFN-co Nasal SprayDrug

    Also called rSIFN-co

    16 million IU (32 μg)/day; Twice daily

  • Placebo Nasal SprayDrug

    Also called ingredients

    Once daily

  • Placebo Nasal SprayDrug

    Also called ingredients

    Twice daily

Study groups in NCT05485584
Study groupRoleWhat they receive
Healthy subjects(A1)ExperimentalEach nostril: 2 sprays/time; Pharynx: 4 sprays/time; Once daily
Receives: Drug: rSIFN-co Nasal Spray
Healthy subjects(A2)Placebo comparatorEach nostril: 2 sprays/time; Pharynx: 4 sprays/time; Once daily
Receives: Drug: Placebo Nasal Spray
COVID-19 subjects(B1)ExperimentalEach nostril: 2 sprays/time; Pharynx: 4 sprays/time; Twice daily
Receives: Drug: rSIFN-co Nasal Spray
COVID-19 subjects(B2)Placebo comparatorEach nostril: 2 sprays/time; Pharynx: 4 sprays/time; Twice daily
Receives: Drug: Placebo Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day1-Day28

  2. 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

    Measured: Day1-Day28

Secondary outcomes (9)

  1. 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.

    Measured: Day1-Day28

  2. 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.

    Measured: Day1-Day10

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

    For healthy subjects only

    Measured: Day1-Day28

  4. Incidence of COVID-19-related complications over 28 days

    For healthy subjects only

    Measured: Day1-Day28

  5. Time to clearance of SARS-CoV-2

    For COVID-19 subjects only. It defined as 2 consecutive negative swabs (sampling interval ≥24 hours)

    Measured: Day1-Day28

  6. Percentage of subjects who require supplemental oxygen or mechanical ventilation

    For COVID-19 subjects only.

    Measured: Day1-Day28

  7. 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

    Measured: Day1-Day10

  8. Time to clinical improvement from the highest outcome scores per 11-point WHO clinical progression scale

    For COVID-19 subjects only.

    Measured: Day1-Day28

  9. Time to resolution of all symptoms present at baseline

    For COVID-19 subjects only.

    Measured: Day1-Day28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start1 Jul 2022
  3. Primary completion5 Apr 2023
  4. Study completion5 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485584
Sponsor's protocol ID
SHL-rSIFN-002
Status last verified
Apr 2024
First submitted
16 Jun 2022
Last updated
25 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rSIFN-co Nasal Spray in people with COVID-19 and SARS-CoV-2 Infection, run by Sichuan Huiyang Life Science and Technology Corporation at 2 sites in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of laboratory-confirmed SARS-CoV-2 infection in health subjects (time frame: Day1-Day28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05485584.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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