A Trial of Novaferon in Asymptomatic or Mild COVID-19 Patients

NCT05017714 | Unknown Phase 3

• 1 other identifier: Jing302H
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase III randomized, double blinded, placebo-controlled multi-center study to assess the efficacy and safety of aerosolized Novaferon for the treatment of asymptomatic or mildly patients infected with SARS-CoV-2.

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (1)

• Time of negative detection of SARS-CoV-2 RNA

  Nucleic acid detection twice at a 24-hour interval

  Day 1 to Day 28

Secondary Outcomes (7)

• Rate of clinical progression

  Day 1 to Day 28

• the change of viral load

  Day 1 to Day 28

• detection rate of SARS-CoV-2 RNA

  Day 1 to Day 28

• Rate of clinical progression in patients vaccinated

  Day 1 to Day 28

• Rate of clinical progression in subgroup of patients vaccinated

  Day 1 to Day 28

Study Arms (2)

Active plus SOC

EXPERIMENTAL

Drug: Recombinant cytokine gene derived protein injection

Placebo plus SOC

PLACEBO COMPARATOR

Drug: Recombinant cytokine gene derived protein injection

Interventions

Recombinant cytokine gene derived protein injection DRUG

Aerosolized Novaferon, given 20 ug BID, daily for 7 days, plus Standard of Care. Inhaled Saline (placebo), given BID, daily for 7 days, plus Standard of Care.

Also known as: Saline

Active plus SOC; Placebo plus SOC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between 18 and 65 years of age at the time of consent. 3.Laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR in nasopharyngeal or oropharyngeal swabs \< 72 hours prior to enrollment.
• Patients with asymptomatics or mild COVID-19, including:
• Patients with asymptomatic infections refer to those with positive testing results in etiological detection of SARS-CoV-2 in swabs, but without any relevant clinical manifestations, such as self-perceived or clinically identified symptoms or signs, including fever, cough and sore throat, and without any typical imaging features of COVID-19 in their CT scans.
• Patients with mild SARS-COV-2 infections refer to those who are infected with SARS-COV-2 presenting mild symptoms in accordance with Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Revision 8): mild clinical symptoms, and no findings of pneumonia in chest CT images.

You may not qualify if:

• Patients who are unable to collaborate due to poor mental health, suffering from psychiatric illness, or incapable of controlling themselves or expressing clearly.
• Patients excluded in the opinion of the investigators.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: August 31, 2021
• Primary Completion: April 30, 2022
• Study Completion: August 31, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08