COVID-19, SARS-CoV-2
Conditions
Brief summary
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.
Detailed description
The study is a multicenter, adaptive, randomized, double-blinded, and placebocontrolled Phase II/III trial. It will be conducted globally. The study will evaluate the efficacy and safety of SCTA01 in high-risk outpatients with COVID-19.The primary objective of the study is to evaluate the clinical efficacy rate among study group \[SCTA01+ standard of care (SOC)\] and control group (placebo + SOC) up to Day 29.
Interventions
DRUGSCTA01
Diluted by 0.9% normal saline，IV
OTHERPlacebo
IV
Sponsors
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 ≤7 days before randomization; * First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤3 days prior to start of the infusion; * Participants are currently not hospitalized; * Participant (or legal authorized representative) has signed the ICF before any clinical activity related to SCTA01 trial; * Women with childbearing potential must agree to use effective contraceptive methods during the study period; * Patient should not participate in other clinical studies related to COVID-19 or SARS-CoV-2 infection.
Exclusion criteria
* Have known allergies to any of the components used in the formulation of the SCTA01/placebo; * 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; * Have any co-morbidity requiring surgery within \<29 days, or that is considered life threatening within 29 days; * Have a history of previous SARS-CoV-2 infection; * Received convalescent plasma, COVID-19 vaccine, or anti-SARS-CoV-2 spike(S) protein targeted therapy; * Have participated in a clinical study involving an investigational intervention within past 30 days or 5-half lives of investigational product, whichever is longer; * Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing; * Pregnant or lactating women; * Anticipated hospitalization or transfer to another medical site which is not a study site within 72 hours; * Participants unable to follow the protocol during the study; * Participants deemed inappropriate for enrollment by the investigator due to other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| - Change in symptom score (total of ratings) | Day 3, 5, 7, 11, 15, 22, and 29 |
| Time to symptom improvement; | Day 29 |
| Proportion of participants admitted to hospital due to COVID-19 | Day 29 |
| Proportion of participants with ≥1 COVID-19 related hospitalization | Day 29 |
| Proportion of participants with ≥2 COVID-19 related hospitalizations | Day 29 |
| Total number of COVID-19 related hospitalization | Day 29 |
| Proportion of participants who experience COVID-19 related emergency room (ER) visit | Day 29 |
| Proportion of participants with ≥1 ER visit due to COVID-19 | Day 29 |
| Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29 | Day 29 |
| Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19 | Day 29 |
| Time to sustained resolution of all COVID-19-related symptoms | Day 29 |
| Proportion of participants with O2 requirement | Day 29 |
| Proportion of participants with ventilation requirements | Day 29 |
| Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples | Day 8, Day 15 |
| Change from baseline (Day 1) to Day 8 or Day 15 in SARS-CoV-2 viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in NP or OP samples for SARS-CoV-2 test. | Day 8, Day 15 |
| Cumulative incidence of serious adverse events (SAEs) | Day 120 |
| Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs) | Day 120 |
| Discontinuation or temporary suspension of infusions (for any reason) | Day 120 |
| Number and proportion of patients with ADE | Day 120 |
| Mean concentration-time profiles of SCTA01 | Day 29 |
| Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01 | Day 1, Day 8, Day 29, and Day 120) |
| Proportion of patients with all-cause mortality | Day 29 |
Contacts
Primary ContactQiang Guo, PhD
Backup ContactZhanghua Lan, PhD
Outcome results
None listed