Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05017714
Other study ID # Jing302H
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date August 31, 2021
Est. completion date August 31, 2022

Study information

Verified date August 2021
Source Beijing 302 Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Since the outbreak of New Coronavirus pneumonia (COVID-19) in late 2019, epidemics around the world are still developing. There are about 200 million confirmed cases in the world, including about 4.26 million deaths until August 5, 2021, which has become a major disaster for human being. Most of SARS-CoV-2 infection are asymptomatic or mild cases, which is the main factor causing viral transmission. Although COVID-19 patients have immune protection after cured or vaccinated, there still be a percentage of people vaccinated who still get sick, hospitalized, or die caused by COVID-19. COVID-19 vaccine breakthrough and reinfection cases became one of key problems for COVID-19 prevention and control. In addition, SARS-CoV-2 variants circulated in the world. However, some variants were associated with disease severity, the performance of vaccines, therapeutic medicines, diagnostic tools, or other public health and social measures. Variants (e.g., Delta variant) caused some vaccine breakthrough cases. There is an urgent need for effective antiviral drugs. Novaferon is a marketed antiviral drug in China and proved to have more than ten-fold antiviral potency than that of similar interferon α-2b. Novaferon exerts antiviral activity by three ways: blocking virus entry into cells, inducing expression of antiviral genes and proteins (e.g., MX1 and OAS), and promoting apoptosis of infected cells. In vitro experimental study showed Novaferon exhibited anti-SARS-CoV-2 effects at the cellular level. A randomized, open-label, parallel-group trial demonstrated that aerosolized Novaferon expedited clearance and negative conversion of SARS-CoV-2, which provide the rational for large-scale clinical studies to verify the efficacy of Novaferon as a potential antiviral drug for COVID-19. Inhalation administration has advantages over systemic administration in reducing adverse drug reactions, promoting the distribution of drugs in respiratory tract, and thus enhancing the mucosal immunity. 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 patients or patients with mild COVID-19.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date August 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Recombinant cytokine gene derived protein injection
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing 302 Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Time of negative detection of SARS-CoV-2 RNA Nucleic acid detection twice at a 24-hour interval Day 1 to Day 28
Secondary Rate of clinical progression at least 4 points on 8-point ordinal Scale developed by WHO Day 1 to Day 28
Secondary the change of viral load viral load cannot be detected Day 1 to Day 28
Secondary detection rate of SARS-CoV-2 RNA cannot detect SARS-CoV-2 RNA Day 1 to Day 28
Secondary Rate of clinical progression in patients vaccinated Time of negative detection of SARS-CoV-2 RNA in patients vaccinated Day 1 to Day 28
Secondary Rate of clinical progression in subgroup of patients vaccinated at least 4 points on 8-point ordinal Scale developed by WHO Day 1 to Day 28
Secondary Rate of clinical progression in patients infected with variants( Delta strain, et al) at least 4 points on 8-point ordinal Scale developed by WHO Day 1 to Day 28
Secondary Safety and tolerability AE score Day 1 to Day 28
See also
  Status Clinical Trial Phase
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Recruiting NCT05311410 - Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures N/A
Active, not recruiting NCT05073718 - SARS-CoV-2 and Acetylsalicylic Acid (SARA) Phase 3
Completed NCT05060510 - The School SPIT Study - COVID-19 Testing in Secondary Schools N/A
Completed NCT05055505 - The School SPIT Study - Elementary Schools in Low COVID-19 Incidence Regions N/A
Completed NCT05055492 - The School SPIT Study - Elementary Schools in High COVID-19 Incidence Regions N/A
Completed NCT05054218 - COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients
Completed NCT05449392 - Topical Antibacterial Agents for Prevention of COVID-19 Phase 1
Completed NCT05076253 - Efficacy of Ivermectin in COVID-19 Phase 1/Phase 2
Recruiting NCT05172024 - Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
Terminated NCT05593770 - International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response Phase 2/Phase 3
Completed NCT05030974 - RECOVAC Repeated Vaccination Study Phase 4
Withdrawn NCT05067946 - Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines Phase 2/Phase 3
Not yet recruiting NCT05013034 - Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients Phase 2
Withdrawn NCT05393999 - SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations Phase 2
Recruiting NCT05047783 - Masitinib in Patients With Symptomatic Mild to Moderate COVID-19 Phase 2
Not yet recruiting NCT05116657 - Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome
Recruiting NCT04590222 - Impact of a Monoamine Oxidase Inhibitor on the Phenotype of Blood Mononucleated Cells in Patients With COVID-19
Completed NCT04551911 - Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 Phase 2
Completed NCT04953039 - Use of Saliva for COVID-19 Diagnosis