Efficacy and safety of CT-P59 plus standard of care: a phase 2/3 randomized, double-blind, placebo-controlled trial in outpatients with mild-to-moderate SARS-CoV-2 infection

Abstract

CT-P59, a monoclonal antibody with potent neutralizing activity against severe acute respiratory syndrome coronavirus 2, may ameliorate symptoms and prevent hospitalization in outpatients with mild-to-moderate disease. We report findings from part one of a two-part randomized, placebo-controlled, double-blind study (NCT04602000; EudraCT: 2020-003369-20). Outpatients with mild-to-moderate COVID-19 received a single dose of CT-P59 40 mg/kg (n=101), CT-P59 80 mg/kg (n=103), or placebo (n=103). Median (95% confidence interval [CI]) time to conversion to negative RT-qPCR result (coprimary endpoint) was 12.8 days (9.00–12.84) with CT-P59 40 mg/kg, 11.9 days (8.94–12.91) with CT-P59 80 mg/kg, and 12.9 days (12.75–13.99) with placebo. Median (95% CI) time to clinical recovery (coprimary endpoint) was 5.4 days (3.97–6.78) with CT-P59 40 mg/kg, 6.2 days (5.53–7.85) with CT-P59 80 mg/kg, and 8.8 days (6.72–11.73) with placebo. The proportion (95% CI) of patients requiring hospitalization or oxygen therapy was lower with CT-P59 40 mg/kg (4.0% [1.6–9.7%]) and CT-P59 80 mg/kg (4.9% [2.1–10.9%]) versus placebo (8.7% [4.7–15.8%). CT-P59 was well tolerated and no serious treatment-emergent adverse events or deaths occurred. In summary, CT-P59 accelerated viral and clinical recovery from COVID-19 and was well tolerated in patients with mild-to-moderate infection.

Regdanvimab: First Approval

“…In a part 1 of a phase II/III trial (NCT04602000) (Sect. 2.3.2 ) in patients with mild-to-moderate SARS-CoV-2 infection, regdanvimab pharmacokinetics following a single 90-min IV infusion was characterized by a low clearance (0.227 mL/kg for 40 mg/kg), small volume of distribution (87.2 mL/kg for 40 mg/kg) and a terminal half-life of 12 days [ 1 , 17 ]. Regdanvimab is likely to be eliminated through normal immunoglobulin degradation pathways and the clearance is not expected to be affected by renal or hepatic impairment [ 1 ].…”

“…The efficacy of regdanvimab in the treatment of mild-to-moderate COVID-19 was evaluated in a randomized, double-blind, placebo-controlled, multinational phase II/III trial (NCT04602000), which was divided in two parts: part 1 (phase II) and part 2 (phase III). Currently, part 1 results are available and regdanvimab was effective in this part [ 17 ]. Eligibility criteria included: age ≥ 18 years; SARS-CoV-2 infection confirmed by quantitative reverse transcription polymerase chain reaction (RT-qPCR); > 94% oxygen saturation on room air and not requiring supplemental oxygen; and, onset of symptoms (feverishness, cough, shortness of breath, sore throat, body/muscle pain, nausea, fatigue, headache, chills, nasal congestion, loss of taste or smell, or diarrhoea) within 7 days prior to study drug administration.…”

Antibody and cellular therapies for treatment of covid-19: a living systematic review and network meta-analysis

“…The supplementary data present the assessment of risk of bias of the included studies for each outcome. Twelve trials5054566065677286 proved at low risk of bias for all domains. All other studies proved at probably high or high risk of bias for at least one domain.…”

“…After screening 52350 titles and abstracts and 1029 full texts, 47 unique randomised controlled trials that evaluated antiviral antibody or cellular treatments were identified as of 21 July 2021 (fig 1). 43444546474849505152535455565758596061626364656667686970717273747576777879808182838485868788 A table of excluded full texts is provided in the supplementary data on bmj.com. Searches of living evidence retrieval services identified 11 publications of eligible randomised trials, which were reconciled with our formal search strategy when necessary 222324254549566466676875838688.…”

“…43444546474849505152535455565758596061626364656667686970717273747576777879808182838485868788 A table of excluded full texts is provided in the supplementary data on bmj.com. Searches of living evidence retrieval services identified 11 publications of eligible randomised trials, which were reconciled with our formal search strategy when necessary 222324254549566466676875838688. Thirty randomised controlled trials were published in a peer reviewed journal, 16 were preprints, and one was an abstract.…”