The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19
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ClinicalTrials.gov Identifier: NCT04644185 |
Recruitment Status :
Recruiting
First Posted : November 25, 2020
Last Update Posted : April 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: SCTA01 Other: Placebo | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 795 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in Hospitalized Patients With Severe COVID-19 |
Actual Study Start Date : | March 27, 2021 |
Estimated Primary Completion Date : | June 27, 2021 |
Estimated Study Completion Date : | December 27, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: SCTA01 Low Dose+BSC
SCTA01in a lower dose+best supportive care
|
Drug: SCTA01
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Other Name: Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody |
Experimental: SCTA01 High Dose+BSC
SCTA01in a higher dose+best supportive care
|
Drug: SCTA01
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Other Name: Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody |
Active Comparator: Placebo+BSC
SCTA01 excipients+best supportive care
|
Other: Placebo
all SCTA01 excipients without active component+best supportive care
Other Name: SCTA01 excipients |
- The clinical efficacy of SCTA01 (Phase II and III) [ Time Frame: Day 29 ]As assessed by time to clinical improvement (TTCI)
- Cumulative incidence of SAEs(Phase II, III) [ Time Frame: 3 Months ]Cumulative incidence of serious adverse events in both Phase II and III
- Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III) [ Time Frame: Day 120 ]Change from baseline in viral shedding as measured by RT-qPCR in NP swab samples
- area under the curve (AUC0-t)(Phase II) [ Time Frame: Day 120 ]AUC0-t through Day 120
- AUC0-∞(Phase II) [ Time Frame: Day 120 ]AUC0-∞ through Day 120
- Half-life time (t1/2)(Phase II) [ Time Frame: Day 120 ]t1/2 through Day 120
- Maximum concentration (Cmax)(Phase II) [ Time Frame: Day 120 ]Cmax through Day 120
- Peak time (Tmax)(Phase II) [ Time Frame: Day 120 ]Tmax through Day 120
- Clearance (CL)(Phase II) [ Time Frame: Day 120 ]CL through Day 120
- Apparent volume of distribution (Vd)(Phase II) [ Time Frame: Day 120 ]Vd through Day 120
- Elimination rate constant (λz)(Phase II) [ Time Frame: Day 120 ]λz through Day 120
- Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III) [ Time Frame: Day 120 ]ADA against SCTA01 at baseline and Day 120

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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]}.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644185
Contact: Ji Qi, PhD | +86-10-5862 8288 ext 9360 | ji_qi@sinocelltech.com |
United States, New Jersey | |
SCT study site | Recruiting |
Somers Point, New Jersey, United States, 08244 | |
Contact: Lucasti | |
Argentina | |
SCT study site | Not yet recruiting |
Ciudad Autonoma de Buenos aires, Argentina | |
Contact: Marcelo | |
Brazil | |
SCT study site | Not yet recruiting |
Uberlândia, Brazil | |
Contact: Arantes | |
Chile | |
SCT study site | Not yet recruiting |
Talca, Chile | |
Contact: Silva | |
Colombia | |
SCT study site | Not yet recruiting |
Rionegro, Colombia | |
Contact: Gomez | |
Mexico | |
SCT study site | Not yet recruiting |
Monterrey, Mexico | |
Contact: Mercado Longoria | |
Peru | |
SCT study site | Not yet recruiting |
Lima, Peru | |
Contact: Carbajal |
Study Director: | Zhanghua Lan, PhD | Sinocelltech Ltd. |
Responsible Party: | Sinocelltech Ltd. |
ClinicalTrials.gov Identifier: | NCT04644185 |
Other Study ID Numbers: |
SCTA01-B301 |
First Posted: | November 25, 2020 Key Record Dates |
Last Update Posted: | April 12, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Myeloma Proteins Paraproteins Immunologic Factors Physiological Effects of Drugs |