COVID-19Phase 1/2NCT05156645
A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19
A Phase 1/2 study testing SCTA01 and SCTA01C in people with COVID-19, run by Sinocelltech Ltd..
Trial summary
The study is comprised of two parts: safety evaluation part (Phase I/II) and the pivotal study (Phase III) to evaluate the efficacy and safety of the combination of SCTA01 \& SCTA01C compared to placebo in addition to Standard of Care (SOC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- SCTA01 and SCTA01C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2022to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female adults, ≥18 years old of age at the time of randomization;
- Participants should have at least one of COVID-19 risk factor;
- Participants should have at least 2 COVID-19 related symptoms;
- Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤10 days before randomization;
- First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion;
Who cannot join
- Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema;
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA);
- Require mechanical ventilation or anticipated impending need for mechanical ventilation;
- Suspected or proven serious bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking part in this study;
- Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
About this study
Official title: An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibody Combination (SCTA01C and SCTA01) for Treatment of Outpatients With COVID-19
The study is comprised of two parts: safety evaluation part (Phase I/II) and the pivotal study (Phase III) to evaluate the efficacy and safety of the combination of SCTA01 \& SCTA01C compared to placebo in addition to Standard of Care (SOC).
- Conditions
- COVID-19
- Being tested
- SCTA01 and SCTA01C, 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.
SCTA01 and SCTA01CDrug
Diluted by 0.9% normal saline
PlaceboDrug
Diluted by 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| SCTA01 and SCTA01C+SOC | Experimental | Not described Receives: Drug: SCTA01 and SCTA01C |
| Placebo+SOC | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29 (Phase III)
Measured: Day 29
Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)
Measured: Day 8
Secondary outcomes (6)
Time to sustained resolution of all COVID-19-related symptoms
Measured: Day 29
Change in symptom score (total of ratings)
Measured: Day 3, 5, 7, 11, 15, 22, and 29
Time to symptom improvement
Measured: Day 29
Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples
Measured: Day 29
Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody
Measured: Day 120
Mean concentration-time profiles of SCTA01 and SCTA01C
Measured: Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start15 Jan 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: The study was withdraw due to the fast spread of Omicron variant worldwide
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.
- More trials run by Sinocelltech Ltd.The 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
- 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
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156645
- Sponsor's protocol ID
- SCTA01/SCTA01C-A301
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibody Combination (SCTA01C and SCTA01) for Treatment of Outpatients With COVID-19
- ClinicalTrials.gov ID
- NCT05156645
- Acronym / sponsor ID
- SCTA01/SCTA01C-A301
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdraw due to the fast spread of Omicron variant worldwide
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 14 Dec 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.
The study is comprised of two parts: safety evaluation part (Phase I/II) and the pivotal study (Phase III) to evaluate the efficacy and safety of the combination of SCTA01 \& SCTA01C compared to placebo in addition to Standard of Care (SOC).
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 |
|---|---|---|
| SCTA01 and SCTA01C+SOC | Experimental | Drug: SCTA01 and SCTA01C |
| Placebo+SOC | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female adults, ≥18 years old of age at the time of randomization;
- Participants should have at least one of COVID-19 risk factor;
- Participants should have at least 2 COVID-19 related symptoms;
- Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤10 days before randomization;
- First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion;
Key exclusion criteria (5 listed)
- Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema;
- Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA);
- Require mechanical ventilation or anticipated impending need for mechanical ventilation;
- Suspected or proven serious bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking part in this study;
- Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
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 |
|---|---|---|
| SCTA01 and SCTA01CDiluted by 0.9% normal saline | Drug | SCTA01 and SCTA01C+SOC |
| PlaceboDiluted by 0.9% normal saline | Drug | Placebo+SOC |
Primary outcome
Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29 (Phase III)
Time frame: Day 29
Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)
Time frame: Day 8
6 secondary outcomes
Time to sustained resolution of all COVID-19-related symptoms
Time frame: Day 29
Change in symptom score (total of ratings)
Time frame: Day 3, 5, 7, 11, 15, 22, and 29
Time to symptom improvement
Time frame: Day 29
Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples
Time frame: Day 29
Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody
Time frame: Day 120
Mean concentration-time profiles of SCTA01 and SCTA01C
Time frame: Day 120
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 27 Jan 2022.
- Individual participant dataSharing planned: Yes
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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 1/2 study testing SCTA01 and SCTA01C in people with COVID-19, run by Sinocelltech Ltd..
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 5 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 27 Jan 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 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?
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?
Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29 (Phase III) (time frame: Day 29). The study lists 2 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 27 Jan 2022.