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

Phase 2

• Conditions: B342 Coronavirus infection, unspecified site; Coronavirus infection, unspecified site; B342

• Registration Number: PER-002-21
• Lead Sponsor: Sinocelltech, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Study Completion: 2022-02-19
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: In enrollment
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Hospitalized patients with severe COVID-19 (5 point on the 8-point ordinal scale). According to the NIH definition, severe patients are those individuals who have one of the following: 1) respiratory rate > 30 breaths per minute 2) SpO2 = 93% on room air at sea level; 3) PaO2/FiO2 < 300 mmHg or SpO2/FiO2= 315 mmHg; 4) lung infiltrates > 50%. In high altitude area (over 1000 meters), PaO2/FiO2 should be corrected according to the following formula: PaO2/FiO2 × [barometric pressure (mmHg/760)]; 5 point: Hospitalized, requiring supplemental oxygen;
• 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. According to the NIH definition, critical patients are those individuals who have one of the following conditions: 1) respiratory failure and need invasive mechanical ventilation; 2) septic shock; 3) multiple organ dysfunction;
• Patients with severe COVID-19 who received convalescent plasma 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]}.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
8-point ordinal scale<br> NAME OF THE RESULT: Time to clinical improvement (TTCI) up to Day 29. TTCI is defined as the time (in days) from randomization to the first day on which a patient satisfies point 1, 2, or 3 on the 8-point ordinal scale and maintains a score = 3 at least 48 hours (initial improvement) and maintains this up to Day 29 (sustained improvement) (Phase II, III).<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Maintains a score = 3 at least 48 hours (initial improvement) and maintains this up to Day 29 (sustained improvement) (Phase II, III).