Covid19
Conditions
Brief summary
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III trial, and will be conducted globally. The study is comprised of two parts: dose selection (Phase II) and pivotal treatment effect (Phase III).
Detailed description
In this study, Phase II part will evaluate the efficacy, safety and PK of SCTA01 low dose+BSC, high dose+BSC and placebo+BSC in patients with severe COVID-19. In Phase II part, subjects will be randomized at 1:1:1 ratio. At the end of Phase II part, a dose for the Phase III will be determined. The Phase III part will evaluate the efficacy, safety, and immunogenicity of SCTA01 at the recommended dose recommended. Subjects in Phase III part will be randomized at 1:1 ratio to SCTA01+BSC and placebo+BSC groups.
Interventions
DRUGSCTA01
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
OTHERPlacebo
all SCTA01 excipients without active component+best supportive care
Sponsors
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients with severe COVID-19 (5 point on NIH 8-point ordinal scale). * Male or female adult ≥18 years of age at time of enrollment; * Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests); * ≤ 10 days since symptoms of COVID-19 onset.
Exclusion criteria
* Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale); * Patients with critical COVID-19; * Patients with Severe COVID-19 who received convalescent plasma or COVID-19 vaccine, or anti-SARS-CoV-2 spike (S) protein targeted therapy; * Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than the upper limit of the normal value; * Estimated glomerular filtration rate (eGFR) \<30 mL/min or on dialysis {eGFR calculated by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = \[(140 - age) × weight (kg)\] × 1/ \[SCr (mg/dL) × 72\]; Female: CrCL (mL/min) = \[(140 - age) × weight (kg)\] × 0.85/ \[SCr (mg/dL) × 72\]}.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinical Improvement up to Day 29 | Day 29 | The median time to clinical improvement in the SCTA01 groups and control group |
Countries
Argentina, Brazil, Chile, Colombia, Mexico, Peru, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SCTA01 Low Dose+BSC SCTA01in a lower dose+best supportive care
SCTA01: SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody | 33 |
| SCTA01 High Dose+BSC SCTA01in a higher dose+best supportive care
SCTA01: SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody | 34 |
| Placebo+BSC SCTA01 excipients+best supportive care
Placebo: all SCTA01 excipients without active component+best supportive care | 35 |
| Total | 102 |
Baseline characteristics
| Characteristic | SCTA01 Low Dose+BSC | SCTA01 High Dose+BSC | Placebo+BSC | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 16 Participants | 14 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 18 Participants | 21 Participants | 58 Participants |
| Age, Continuous | 48 years | 48 years | 44 years | 47 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 29 Participants | 29 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 22 Participants | 25 Participants | 0 Participants | 47 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 10 Participants | 34 Participants |
| Sex: Female, Male Male | 21 Participants | 22 Participants | 25 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 33 | 2 / 34 | 3 / 35 |
| other Total, other adverse events | 9 / 33 | 16 / 34 | 11 / 35 |
| serious Total, serious adverse events | 7 / 33 | 5 / 34 | 5 / 35 |
Outcome results
Primary
Time to Clinical Improvement up to Day 29
The median time to clinical improvement in the SCTA01 groups and control group
Time frame: Day 29
Population: There is no difference beteeen the numbers of participants or units assigned to the arms or groups .
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low dose group | Time to Clinical Improvement up to Day 29 | 9 days |
| High dose group | Time to Clinical Improvement up to Day 29 | 9 days |
| Placebo group | Time to Clinical Improvement up to Day 29 | 10 days |