Trial Outcomes & Findings for The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19 (NCT NCT04644185)
NCT ID: NCT04644185
Last Updated: 2025-10-24
Results Overview
The median time to clinical improvement in the SCTA01 groups and control group
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
102 participants
Primary outcome timeframe
Day 29
Results posted on
2025-10-24
Participant Flow
Participant milestones
| Measure |
Low dose group
SCTA01 15 mg/kg plus best supportive care (BSC)
|
High dose group
SCTA01 50 mg/kg plus best supportive care (BSC)
|
Placebo group
Placebo plus best supportive care (BSC)
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
35
|
34
|
|
Overall Study
COMPLETED
|
33
|
35
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19
Baseline characteristics by cohort
| Measure |
SCTA01 Low Dose+BSC
n=33 Participants
SCTA01in a lower dose+best supportive care
SCTA01: SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
|
SCTA01 High Dose+BSC
n=34 Participants
SCTA01in a higher dose+best supportive care
SCTA01: SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
|
Placebo+BSC
n=35 Participants
SCTA01 excipients+best supportive care
Placebo: all SCTA01 excipients without active component+best supportive care
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
58 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
44 Participants
n=31 Participants
|
|
Age, Continuous
|
48 years
n=39 Participants
|
48 years
n=41 Participants
|
44 years
n=35 Participants
|
47 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
34 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
68 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
47 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
29 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: There is no difference beteeen the numbers of participants or units assigned to the arms or groups .
The median time to clinical improvement in the SCTA01 groups and control group
Outcome measures
| Measure |
Low dose group
n=33 Participants
SCTA01 15 mg/kg plus best supportive care (BSC)
|
High dose group
n=34 Participants
SCTA01 50 mg/kg plus best supportive care (BSC)
|
Placebo group
n=35 Participants
Placebo plus best supportive care (BSC)
|
|---|---|---|---|
|
Time to Clinical Improvement up to Day 29
|
9 days
Interval 7.0 to 14.0
|
9 days
Interval 6.0 to 15.0
|
10 days
Interval 7.0 to 15.0
|
Adverse Events
SCTA01 Low Dose+BSC
Serious events: 7 serious events
Other events: 9 other events
Deaths: 2 deaths
SCTA01 High Dose+BSC
Serious events: 5 serious events
Other events: 16 other events
Deaths: 2 deaths
Placebo+BSC
Serious events: 5 serious events
Other events: 11 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
SCTA01 Low Dose+BSC
n=33 participants at risk
SCTA01in a lower dose+best supportive care
SCTA01: SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
|
SCTA01 High Dose+BSC
n=34 participants at risk
SCTA01in a higher dose+best supportive care
SCTA01: SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
|
Placebo+BSC
n=35 participants at risk
SCTA01 excipients+best supportive care
Placebo: all SCTA01 excipients without active component+best supportive care
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.1%
3/33 • Number of events 3 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
0.00%
0/34 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
2.9%
1/35 • Number of events 1 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
|
Cardiac disorders
Cardiac Disorder
|
6.1%
2/33 • Number of events 2 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
2.9%
1/34 • Number of events 1 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
5.7%
2/35 • Number of events 2 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
|
Infections and infestations
Infection
|
9.1%
3/33 • Number of events 3 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
8.8%
3/34 • Number of events 3 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
5.7%
2/35 • Number of events 2 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.0%
1/33 • Number of events 1 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
8.8%
3/34 • Number of events 3 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
2.9%
1/35 • Number of events 1 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
Other adverse events
| Measure |
SCTA01 Low Dose+BSC
n=33 participants at risk
SCTA01in a lower dose+best supportive care
SCTA01: SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
|
SCTA01 High Dose+BSC
n=34 participants at risk
SCTA01in a higher dose+best supportive care
SCTA01: SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
|
Placebo+BSC
n=35 participants at risk
SCTA01 excipients+best supportive care
Placebo: all SCTA01 excipients without active component+best supportive care
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders Constipaton
|
18.2%
6/33 • Number of events 6 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
32.4%
11/34 • Number of events 11 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
11.4%
4/35 • Number of events 4 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
|
General disorders
Pyrexia
|
9.1%
3/33 • Number of events 3 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
17.6%
6/34 • Number of events 6 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
5.7%
2/35 • Number of events 2 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • Number of events 2 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
8.8%
3/34 • Number of events 3 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
11.4%
4/35 • Number of events 4 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
8.8%
3/34 • Number of events 3 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
8.6%
3/35 • Number of events 3 • The advese events were collected over 120 days
An adverse event (AE) is any unfavorable or unintended sign, symptom, disease, or abnormal lab result related to a medicinal product, regardless of causality. It includes new/worsening conditions, procedure complications, lack of efficacy, overdose, misuse, or occupational exposure. A serious AE (SAE) results in death, life-threatening risk, hospitalization, disability, birth defect, or other important events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place