Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People

NCT05667714 | Unknown

• 1 other identifier: PRO-SA58-0002
• Study Type: interventional
• Target: 2,900
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in close contact with COVID-19 people.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence of symptomatic COVID-19 cases

  Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period

  Up to 30 days(during case surveillance period)

Secondary Outcomes (6)

• Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by different Ct values at the time of diagnosis of primary cases(≤30, >30)

  Up to 30 days (during case surveillance period)

• Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval

  Up to 30 days (during case surveillance period)

• The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR

  Up to 30 days (during case surveillance period)

• The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)

  Up to 30 days (during case surveillance period)

• The peak Ct value

  Up to 30 days (during case surveillance period)

Study Arms (4)

Experimental Group A（ non-continuous exposure to COVID-19）

EXPERIMENTAL

1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.

Drug: SA58 Nasal Spray

Control Group A（ non-continuous exposure to COVID-19）

PLACEBO COMPARATOR

575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day .

Drug: Placebo

Experimental Group B (continuous exposure to COVID-19)

EXPERIMENTAL

400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.

Drug: SA58 Nasal Spray

Control Group B(continuous exposure to COVID-19)

PLACEBO COMPARATOR

200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.

Drug: Placebo

Interventions

SA58 Nasal Spray DRUG

SA58 nasal spray , provided by Sinovac Life Sciences Co. , Ltd. mainly consists of neutralizing antibody of COVID-19, with 5 mg neutralizing antibody of COVID-19 per ml, 20 sprays per bottle.

Experimental Group A（ non-continuous exposure to COVID-19）; Experimental Group B (continuous exposure to COVID-19)

Placebo DRUG

Placebo was provided by Sinovac Life Sciences Co. , Ltd.

Control Group A（ non-continuous exposure to COVID-19）; Control Group B(continuous exposure to COVID-19)

Eligibility Criteria

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

You may qualify if:

• Subjects aged 18 years and above on the day of enrollment;
• Had recent contact with an infected person, and the time of PCR sampling from a positive infected person, or the time of first contact with a positive infected person should not exceed 72 hours;
• The subjects can understand and voluntarily sign the informed consent form;

You may not qualify if:

• Previous history of severe allergy or sensitivity to inhalation allergens;
• Women are breastfeeding, pregnant, or planning to become pregnant during the study period;
• Participated in clinical trials of SARS-CoV-2 neutralizing antibody injections within 180 days prior to screening or clinical trials of other drugs within 4 weeks prior to screening;
• Subjects unable to cooperate with nasal spray inhalation;
• Body temperature at baseline (Day 0)\>37.0℃;
• Had a severe neurological disorder (epilepsy, convulsions or convulsions) or psychosis, and have a family history of psychosis;
• The researchers determined that the subjects had a serious chronic medical condition that could interfere with the conduct or completion of the study;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead
• Beijing Ditan Hospital: collaborator

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, China

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

• Ronghua Jin

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 29, 2022
• Study Start: November 26, 2022
• Primary Completion: December 30, 2022
• Study Completion: March 30, 2023
• Last Updated: January 12, 2023

Record last verified: 2022-12

Locations

CN (1)