Clinical Trials Logo

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT05485584
Study type Interventional
Source Sichuan Huiyang Life Science and Technology Corporation
Contact Li Zhang
Phone +65-6222 2655
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date July 1, 2022
Completion date February 28, 2023

See also
  Status Clinical Trial Phase
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Active, not recruiting NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Active, not recruiting NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Recruiting NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Active, not recruiting NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Enrolling by invitation NCT05089305 - Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection Phase 2
Recruiting NCT04528901 - Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
Active, not recruiting NCT04527471 - Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Completed NCT04357990 - Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 N/A
Recruiting NCT05041907 - Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) Phase 2
Active, not recruiting NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Not yet recruiting NCT04990466 - Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine. Phase 2/Phase 3
Recruiting NCT04661462 - Health After Covid-19 in Tyrol
Recruiting NCT05323799 - The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)