Overview

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

Status:
Not yet recruiting
Trial end date:
2022-08-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing 302 Hospital
Criteria
Inclusion Criteria:1.Patient capable of giving consent, or, when the patient is not capable
of giving consent, by his or her legal/authorized representatives prior to initiation of
any study procedures.

2.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.

4Patients with asymptomatics or mild COVID-19, including:

1. 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.

2. 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.

-

Exclusion Criteria:1.Patients classified into Moderate, Severe, and Critical cases
according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial
8th Edition) 2.Females who are breast-feeding, lactating, pregnant or intending to become
pregnant 3.Patients who are receiving any treatment with interferon or participating in
other clinical studies of antiviral therapy.

4.Patients who are unable to collaborate due to poor mental health, suffering from
psychiatric illness, or incapable of controlling themselves or expressing clearly.

5.Patients excluded in the opinion of the investigators.

-