Close Contact TransmissionPhase 1/2NCT05415241
Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of COVID-19 Close Contacts
A Phase 1/2 study testing FB2001 in people with Close Contact Transmission, run by Ruijin Hospital.
Trial summary
This is a single-arm, open-label, dose ramp-up exploratory clinical trial to evaluate the efficacy, safety and tolerance of aerosol inhalation of FB2001 as post-exposure prophylaxis among close contacts of COVID-19 patients. This study will enroll 20 to 60 close contacts of COVID-19 patients aging 18 to 65 years. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Close Contact Transmission
- What is being tested?
- FB2001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2022to 31 Dec 2022
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female individuals aged 18-65 years.
- COVID-19 close contacts determined by epidemiological investigation (living in the same room within 72 hours before screening with individuals having positive nucleic acid amplification test for SARS-CoV-2 ).
- Having two consecutive negative nucleic acid tests within 72 hours before enrollment.
- Participants of childbearing age must agree to use a highly effective method of contraception.
- Sign the informed consent form.
Who cannot join
- Pregnant women.
- Participants who have history of prior drug allergy or are vulnerable to allergy.
- Participants who infected with SARS-CoV-2 within previous 6 months.
- Fever (body temperature > 38 ℃), frequent cough and other symptoms suggestive of COVID-19 upon screening.
- Participants with a history of asthma or chronic obstructive pulmonary disease.
- Participants with known history of active liver disease, acute kidney disease or chronic kidney disease.
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- Participants with known history of stroke (except cavity infarction), serious heart disease or myocardial infarction.
- Participants with known diagnosis of Alzheimer's disease, Parkinson's disease or tumor (except for radical tumor resection).
- Blood pressure >180/100mmHg at screening.
- Participated in other interventional studies within previous 6 months.
- Uptaking CYP3A4/5 strong inducers or inhibitors (rifampicin, phenytoin, carbamazepine, St. John's wort, clarithromycin, itraconazole, ketoconazole, ritonavir, cobicistat, darunavir, atazanavir, lopinavir, nelmatevir, nefazodone, etc.).
- Participants who need to use other anti-SARS-CoV-2 therapeutic drugs during the study period.
- Other conditions are considered unsuitable to participate in the researcher after evaluation by the researcher.
Trial locations and contacts
No sites are listed yet.
Yanping Xu, PhD contact
About this study
Official title: Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of Close Contacts of COVID-19 Patients
This is a single-arm, open-label, dose ramp-up exploratory clinical trial to evaluate the efficacy, safety and tolerance of aerosol inhalation of FB2001 as post-exposure prophylaxis among close contacts of COVID-19 patients.
This study will enroll 20 to 60 close contacts of COVID-19 patients aging 18 to 65 years.
After signing the informed consent form, the qualified subjects will be given FB2001 once or twice daily.
- Conditions
- Close Contact Transmission
- Being tested
- FB2001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB2001Drug
Stage 1 (Exploring the dose): Twenty participants will be enrolled for aerosol inhalation of FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, another twenty participants will be enrolled for aerosol inhalation of FB2001 BID for 5 consecutive days.
Stage 2 (Sample size expansion): Another twenty participants will be enrolled for aerosol inhalation of FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1.
| Study group | Role | What they receive |
|---|---|---|
| FB2001Exploratory | Experimental | Stage 1 (Exploring the dose): FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, FB2001 BID for 5 consecutive days.
Stage 2 (Sample size expansion): FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1. Receives: Drug: FB2001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy index of post-exposure prophylaxis against COVID-19
The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 7 days post inhalation of FB2001.
Measured: 7 days post aerosol inhalation of FB2001
efficacy index of post-exposure prophylaxis against COVID-19
The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 14 days post inhalation of FB2001.
Measured: 14 days post aerosol inhalation of FB2001
safety index
The number of cases of intolerance or anaphylaxis, as well as the incidence of treatment-related adverse events (TRAEs) during aerosol inhalation therapy.
Measured: during aerosol inhalation of FB2001 or 30 minutes (or longer, if necessary) post aerosol inhalation of FB2001
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start9 Jun 2022 (estimated)
- Primary completion9 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Close Contact TransmissionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Frontier Biotechnologies Inc., Shanghai Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415241
- Sponsor's protocol ID
- FB2001-PEP-1
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 13 Jun 2022
- 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 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of Close Contacts of COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05415241
- Acronym / sponsor ID
- FB2001-PEP-1
- Conditions
- Close Contact Transmission
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Frontier Biotechnologies Inc., Shanghai Center for Disease Control and Prevention
- Study start
- 9 Jun 2022 (estimated)
- Primary completion
- 9 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Jun 2022 (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 single-arm, open-label, dose ramp-up exploratory clinical trial to evaluate the efficacy, safety and tolerance of aerosol inhalation of FB2001 as post-exposure prophylaxis among close contacts of COVID-19 patients.
This study will enroll 20 to 60 close contacts of COVID-19 patients aging 18 to 65 years.
After signing the informed consent form, the qualified subjects will be given FB2001 once or twice daily.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FB2001Exploratory | Experimental | Drug: FB2001Stage 1 (Exploring the dose): FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, FB2001 BID for 5 consecutive days. Stage 2 (Sample size expansion): FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female individuals aged 18-65 years.
- COVID-19 close contacts determined by epidemiological investigation (living in the same room within 72 hours before screening with individuals having positive nucleic acid amplification test for SARS-CoV-2 ).
- Having two consecutive negative nucleic acid tests within 72 hours before enrollment.
- Participants of childbearing age must agree to use a highly effective method of contraception.
- Sign the informed consent form.
Key exclusion criteria (13 listed)
- Pregnant women.
- Participants who have history of prior drug allergy or are vulnerable to allergy.
- Participants who infected with SARS-CoV-2 within previous 6 months.
- Fever (body temperature > 38 ℃), frequent cough and other symptoms suggestive of COVID-19 upon screening.
- Participants with a history of asthma or chronic obstructive pulmonary disease.
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 |
|---|---|---|
| FB2001Stage 1 (Exploring the dose): Twenty participants will be enrolled for aerosol inhalation of FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, another twenty participants will be enrolled for aerosol inhalation of FB2001 BID for 5 consecutive days. Stage 2 (Sample size expansion): Another twenty participants will be enrolled for aerosol inhalation of FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1. | Drug | FB2001Exploratory |
Primary outcome
efficacy index of post-exposure prophylaxis against COVID-19
Time frame: 7 days post aerosol inhalation of FB2001
The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 7 days post inhalation of FB2001.
efficacy index of post-exposure prophylaxis against COVID-19
Time frame: 14 days post aerosol inhalation of FB2001
The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 14 days post inhalation of FB2001.
safety index
Time frame: during aerosol inhalation of FB2001 or 30 minutes (or longer, if necessary) post aerosol inhalation of FB2001
The number of cases of intolerance or anaphylaxis, as well as the incidence of treatment-related adverse events (TRAEs) during aerosol inhalation therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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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.
Yanping Xu, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FB2001 in people with Close Contact Transmission, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. 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 13 Jun 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jieming Qu, PhD (0086-021-64370045, jmqu0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy index of post-exposure prophylaxis against COVID-19 (time frame: 7 days post aerosol inhalation of FB2001). The study lists 3 primary outcomes in all. 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 13 Jun 2022.