SARS-CoV2 InfectionPhase 3NCT05017714
A Trial of Novaferon in Asymptomatic or Mild COVID-19 Patients
A Phase 3 study testing Recombinant cytokine gene derived protein injection in people with SARS-CoV2 Infection, run by Beijing 302 Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Recombinant cytokine gene derived protein injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2021to 31 Aug 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- 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. -
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.
-
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Aerosolized Novaferon in Asymptomatic and Mildly Symptomatic Patients Infected With SARS-CoV-2.
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.
Read the detailed 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.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Recombinant cytokine gene derived protein injection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant cytokine gene derived protein injectionDrug
Also called Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Active plus SOC | Experimental | Not described Receives: Drug: Recombinant cytokine gene derived protein injection |
| Placebo plus SOC | Placebo comparator | Not described Receives: Drug: Recombinant cytokine gene derived protein injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of negative detection of SARS-CoV-2 RNA
Nucleic acid detection twice at a 24-hour interval
Measured: Day 1 to Day 28
Secondary outcomes (7)
Rate of clinical progression
at least 4 points on 8-point ordinal Scale developed by WHO
Measured: Day 1 to Day 28
the change of viral load
viral load cannot be detected
Measured: Day 1 to Day 28
detection rate of SARS-CoV-2 RNA
cannot detect SARS-CoV-2 RNA
Measured: Day 1 to Day 28
Rate of clinical progression in patients vaccinated
Time of negative detection of SARS-CoV-2 RNA in patients vaccinated
Measured: Day 1 to Day 28
Rate of clinical progression in subgroup of patients vaccinated
at least 4 points on 8-point ordinal Scale developed by WHO
Measured: Day 1 to Day 28
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
Measured: Day 1 to Day 28
Safety and tolerability
AE score
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start31 Aug 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017714
- Sponsor's protocol ID
- Jing302H
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Aerosolized Novaferon in Asymptomatic and Mildly Symptomatic Patients Infected With SARS-CoV-2.
- ClinicalTrials.gov ID
- NCT05017714
- Acronym / sponsor ID
- Jing302H
- Conditions
- SARS-CoV2 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 31 Aug 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active plus SOC | Experimental | Drug: Recombinant cytokine gene derived protein injection |
| Placebo plus SOC | Placebo comparator | Drug: Recombinant cytokine gene derived protein injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant cytokine gene derived protein injectionAlso: SalineAerosolized 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. | Drug | Active plus SOC, Placebo plus SOC |
Primary outcome
Time of negative detection of SARS-CoV-2 RNA
Time frame: Day 1 to Day 28
Nucleic acid detection twice at a 24-hour interval
7 secondary outcomes
Rate of clinical progression
Time frame: Day 1 to Day 28
the change of viral load
Time frame: Day 1 to Day 28
detection rate of SARS-CoV-2 RNA
Time frame: Day 1 to Day 28
Rate of clinical progression in patients vaccinated
Time frame: Day 1 to Day 28
Rate of clinical progression in subgroup of patients vaccinated
Time frame: Day 1 to Day 28
Rate of clinical progression in patients infected with variants( Delta strain, et al)
Time frame: Day 1 to Day 28
Safety and tolerability
Time frame: Day 1 to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant cytokine gene derived protein injection in people with SARS-CoV2 Infection, run by Beijing 302 Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of negative detection of SARS-CoV-2 RNA (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.