J&J initiated the 60,000 patient, Phase III, ENSEMBLE trial (NCT04505722) to evaluate a single dose of JNJ-78436735 for the prevention of COVID-19 in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. In an unreviewed trial report, JNJ-78436735 elicited neutralizing antibodies in a 394 patient, Phase I/II trial. The most frequent adverse events were injection site pain, fatigue, headache and myalgia.
Novavax initiated a 10,000 patient, Phase III trial to evaluate two doses of NVX-CoV2373 given 21-days apart for the prevention of COVID-19 in the United Kingdom. At least 25% of trial participants will be 65 or older.
The FDA placed a hold on a Phase II/III trial evaluating Inovio’s COVID-19 vaccine, INO-4800, due to questions regarding the vaccine and the Cellectra 2000 delivery device used in the trial.
In a 40 patient, Phase I, NIAID-sponsored, open-label trial (NCT04283461), the antibody titers increased in patients > 56 that were similar to those seen in younger patients. Antibody titers further increased with a booster dose at 1-month. As with the trial of younger patients, serum-neutralizing activity was similar to the levels seen in recovered patients. Adverse events were primarily mild to moderate (e.g., chills, fatigue) and occurred more frequently after the second vaccination.
Regeneron announced data from the first 275 patients enrolled in a 1,300 patient, adaptative Phase I/II/III trial (NCT04425629), where treatment with REGN-COV2 lowered viral levels to a greater extent at increasing viral loads. The monoclonal antibody appeared to be more efficacious in patients that had not produced antibodies and/or had higher viral loads. REGN-COV2 may alleviate symptoms in a shorter time compared to placebo, but in the preliminary data, the numerical reduction (seronegative patients only) was not statistically significant.
Toyama announced that 156 patient, Phase III trial, patients treated with favipiravir cleared SARS-CoV 2 viral RNA in 11.9 days compared to 14.7 days with placebo in Japanese patients with COVID-19 and non-severe pneumonia.