COVID-19 Update #64 for 1/20/2020

COVID-19 Vaccines
 
In an 805 patient, Phase I/IIa trial (NCT04436276), JNJ’s COVID-19 vaccine, Ad26.COV2.S, elicited neutralizing antibodies in two cohorts of patients (18-55 and 65 or older). 29 days after the first dose, neutralizing-antibodies were produced in 99% of patients in the younger cohort and 96% of patients in the older cohort. Antibody titers continued to increase at day 57. A higher dose of the vaccine elicited more antibodies than the lower dose. Some patients received a second dose of the vaccine, which resulted in even higher antibody levels. Longer term data comparing one-dose and two-dose regimens will be reported in the future. The most frequent adverse events were injection site pain, fatigue, headache and myalgia. Adverse events were less common in older patients than younger patients. JNJ is evaluating Ad26.COV2.S  in two Phase III trial. A one-dose regimen is used in the ENSEMBLE trial (NCT04505722) and a two-dose regimen is used in the ENSEMBLE-2 trial NCT04614948)
 
COVID-19 Antibodies
 
Celltrion is evaluating regdanvimab (CT-P59) in the treatment of mild-to-moderate COVID-19. Regdanvimab is a neutralizing monoclonal antibody targeting SARS-CoV-2. 

• Celltrion announced interim data from 327 patients enrolled in a 1,020 patient, Phase II/III trial (NCT04602000), where treatment with low dose of regdanvimab (40mg/kg) reduced progression to severe COVID-19, at 28-days, by 54% compared to placebo in patients with mild-to-moderate COVID-19. Patients with a low dose of regdanvimab recovered in 5.4 days compared to 8.8 days with placebo.
• Celltrion plans to initiate a global Phase III trial to gain more comprehensive safety and efficacy and provide the evidence needed for an Emergency Use Authorization (EUA) in the U.S. and Europe.

 
A retrospective review (NCT04338360) examined outcomes from 3,082 hospitalized COVID-19 patients who received convalescent plasma. At 30 days, mortality was 22.3% in patients that received convalescent plasma with high antibody titers, 27.4% with medium titers and 29.6% with low titers. An improvement in mortality was only significant in patients who didn't receive mechanical ventilation. Patients that received convalescent plasma within three days of a positive test had lower mortality than those who received it later.
 
COVID-19 Antivirals
 
NIH found insufficient evidence to recommend either for or against the use of ivermectin for the treatment of COVID-19. The NIH panel recommends well-designed, adequately powered studies to determine the safety and efficacy of ivermectin to treat COVID-19, since current trials have incomplete data or flawed designs.