The Safety and Efficacy of SCTA01 Against COVID-19 in Patients Admitted to High Dependence or Intensive Care

NCT04683328 | Unknown Phase 2

• 1 other identifier: SCTA01-C301
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an adaptive, randomized, double-blinded, placebo-controlled, Phase II/III study conducted to evaluate the effect of SCTA01 on participant survival and clinical efficacy in participants with severe COVID-19 admitted to high dependence or ICUs. The study duration of subject participation will be up to: 120 days Participants will receive a single intravenous (IV) infusion of SCTA01 at Treatment day 1. Follow up visits will be up to 120 days or early withdrawal visit.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• All-cause mortality rate at D29

  The mortality rates in placebo and treatment groups regardless of the cause of death.

  Day 29

Secondary Outcomes (8)

• All-cause mortality rate at Day 60

  Day 60

• Time to discontinue mechanical ventilation (MV) at Day 29

  Baseline through Day 29

• Time to improvement of two categories on WHO 10-Point Ordinal Scale from baseline at Day 29

  Baseline through Day 29

• Time to discontinue supplemental oxygen at Day 29

  Baseline through Day 29

• Time to hospital free at Day 29

  Baseline through Day 29

Study Arms (2)

SCTA01 Group

EXPERIMENTAL

SCTA01+Best Supportive Care

Biological: SCTA01

Placebo Group

PLACEBO COMPARATOR

Placebo+Best Supportive Care

Biological: SCTA01 Placebo

Interventions

SCTA01 BIOLOGICAL

Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

SCTA01 Group

SCTA01 Placebo BIOLOGICAL

The excipients of SCTA01

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female of ≥18years at time of enrollment;
• Subject (or legally authorized representative \[LAR\]) is able and willing to provide written or verbal informed consent, which includes compliance with study requirements and restrictions listed in the consent form.
• Female subjects must agree to use an approved highly effective birth control (BC) method (\<1% failure rate per year) throughout the study (until completion of the Day 85 Follow-up Visit), unless documented to have a reproductive status of non-childbearing potential or is postmenopausal:
• Non-childbearing potential defined as pre-menopausal female with medical history of bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy; hysteroscopic sterilization,
• Postmenopausal defined as 12 months of spontaneous amenorrhea
• Woman of childbearing potential (WCBP) who is already using an established method of highly effective contraception or agrees to use one of the allowed BC methods listed in the protocol, for at least 28 days prior to the start of dosing (as determined by the Investigator or designee) to sufficiently minimize the risk of pregnancy throughout study participation (until completion of the Day 90 Follow-up Visit).
• Hospitalized participants with severe COVID-19（6-8 point on WHO 10-Point Ordinal Scale):
• Point 6: Oxygen by NIV or high flow;
• Point 7: Intubation and MV, pO2/FiO2 ≥ 150 mmHg or SpO2/FiO2 ≥ 200 mmHg;
• Point 8: MV pO2/FiO2 \< 150 mmHg (or SpO2/FiO2 \< 200 mmHg) or vasopressors .
• Biological samples (not limited to any specific type) collected within 72 hours (allow retesting for potential subjects that tested positive beyond 72 hours) before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR, etc.);
• ≤ 14 days since the onset of COVID-19 symptoms.

You may not qualify if:

• Subject has been intubated for \>72 hours. Note: in the event of extubation and re-intubation, the calculation for the number of hours the subject has been intubated begins at the first intubation
• Require or anticipated need for extracorporeal membrane oxygenation (ECMO) Suspected or proven septic shock or shock ;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is \>5 times higher than the upper limit normal range;
• Severe chronic respiratory disease (e.g., known chronic obstructive pulmonary disease \[COPD\], pulmonary arterial hypertension \[PAH\], idiopathic pulmonary fibrosis \[IPF\], interstitial lung disease \[ILD\]) requiring supplemental oxygen therapy or mechanical ventilation pre-hospitalization (e.g., prior to COVID-19 diagnosis)
• Use of prohibited medications
• Participants with severe COVID-19 who received convalescent plasma or COVID-19 vaccine , or anti-spike (S) SARS-CoV-2 therapy.
• Moribund condition in the opinion of the clinical team

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Related Publications (1)

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

upanovimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhanghua Lan, PhD

  SCT

  STUDY DIRECTOR

Central Study Contacts

Ji Qi, PhD

CONTACT

+86-10-5862 8288; ji_qi@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SCTA01+BSC vs Placebo+BSC

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: February 25, 2021
• Primary Completion: May 25, 2021
• Study Completion: November 25, 2021
• Last Updated: January 20, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share