COVID-19Phase 3NCT05224856
To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen
A Phase 3 study of COVID-19, run by Celltrion.
Trial summary
This is a Phase 3 study to assess the efficacy about therapeutic effect of inhaled CT-P63 and CT-P66 combination therapy to symptomatic patiemts with COVID-19 and overall safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patient, aged 18 or above.
- Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR.
- Patient with conditions meeting all of the following criteria:
- Oxygen saturation ≥ 94% on room air.
- Not requiring supplemental oxygen.
- Patient who has onset of one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration.
Who cannot join
- Patient with current serious condition meeting one of the following:
- Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.
- Respiratory distress with respiratory rate ≥30 breaths/min.
- Severe pneumonia
- Requires supplemental oxygen
- Experience shock
Show all 12Show fewer
- Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
- Patient who has received or has a plan to receive any of following prohibited medications or treatments:
- Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to nirmatrelvir and ritonavir, molnupiravir, remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), and other immunomodulatory agents and human immunodeficiency virus protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
- Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of COVID-19 infection prior to study drug administration
- Any approved monoclonal antibody (sotrovimab, casirivimab and imdevimab, bamlanivimab and etesevimab, etc), any other investigational device or medical product including but not limited to any monoclonal antibody(tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of COVID-19 infection prior to the first study drug administration.
- Any investigational vaccine for SARS-CoV-2.
About this study
Official title: A Phase 3, Randomized, Parallel-group, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With Coronavirus Disease 2019 (COVID-19) Not Requiring Supplemental Oxygen
This is a Phase 3 study to assess the efficacy about therapeutic effect of inhaled CT-P63 and CT-P66 combination therapy to symptomatic patiemts with COVID-19 and overall safety.
Read the detailed description
CT-P63 and CT-P66 are monoclonal antibodies targeted against SARS-CoV-2 spike receptor binding domain as a treatment for COVID-19 infection. CT-P63 and CT-P66 are currently being developed by the Sponsor as a potential treatment for COVID-19 infection. In this study, efficacy, safety, and virology of inhaled CT-P63 and CT-P66 will be evaluated in symptomatic patients with COVID-19 Infection.
- Conditions
- COVID-19
- Being tested
- CT-P63 and CT-P66 / Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P63 and CT-P66 / PlaceboBiological
Inhalation
| Study group | Role | What they receive |
|---|---|---|
| CT-P63 and CT-P66 | Experimental | Not described Receives: Biological: CT-P63 and CT-P66 / Placebo |
| Placebo | Placebo comparator | Not described Receives: Biological: CT-P63 and CT-P66 / Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical recovery
To evaluate the therapeutic efficacy of CT-P63 and CT-P66 combination therapy as of clinical recovery of the patients' COVID-19 symptoms.
Measured: Up to Day 14
Secondary outcomes (1)
Overall safety
To evaluate overall safety of inhaled CT-P63 and CT-P66
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study startApr 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: The sponsor has decided to stop development of the inhaled CT-P63/66 combination therapy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224856
- Sponsor's protocol ID
- CT-P63/66 3.1
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Parallel-group, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With Coronavirus Disease 2019 (COVID-19) Not Requiring Supplemental Oxygen
- ClinicalTrials.gov ID
- NCT05224856
- Acronym / sponsor ID
- CT-P63/66 3.1
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor has decided to stop development of the inhaled CT-P63/66 combination therapy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 4 Feb 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 Phase 3 study to assess the efficacy about therapeutic effect of inhaled CT-P63 and CT-P66 combination therapy to symptomatic patiemts with COVID-19 and overall safety.
Detailed description
CT-P63 and CT-P66 are monoclonal antibodies targeted against SARS-CoV-2 spike receptor binding domain as a treatment for COVID-19 infection. CT-P63 and CT-P66 are currently being developed by the Sponsor as a potential treatment for COVID-19 infection. In this study, efficacy, safety, and virology of inhaled CT-P63 and CT-P66 will be evaluated in symptomatic patients with COVID-19 Infection.
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 |
|---|---|---|
| CT-P63 and CT-P66 | Experimental | Biological: CT-P63 and CT-P66 / Placebo |
| Placebo | Placebo comparator | Biological: CT-P63 and CT-P66 / Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or female patient, aged 18 or above.
- Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR.
- Patient with conditions meeting all of the following criteria:
- Patient who has onset of one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration.
Key exclusion criteria (12 listed)
- Patient with current serious condition meeting one of the following:
- Patient who has received or has a plan to receive any of following prohibited medications or treatments:
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 |
|---|---|---|
| CT-P63 and CT-P66 / PlaceboInhalation | Biological | CT-P63 and CT-P66, Placebo |
Primary outcome
Time to clinical recovery
Time frame: Up to Day 14
To evaluate the therapeutic efficacy of CT-P63 and CT-P66 combination therapy as of clinical recovery of the patients' COVID-19 symptoms.
1 secondary outcome
Overall safety
Time frame: Up to Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No
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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 of COVID-19, run by Celltrion.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 25 Jul 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 to clinical recovery (time frame: Up to Day 14). 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 25 Jul 2022.