COVID-19 Update #88 for 6/23/2021

COVID-19 Vaccines
 
Curevac announced interim data from the 36,500 patient, Phase IIb/III, HERALD trial (NCT04652102), where the mRNA COVID-19 vaccine CVnCo demonstrated 47% efficacy after 134 cases of COVID-19 developed in the European and Latin American study population. An analysis of COVID-19 cases found all but one infection was from COVID-19 variants.
 
COVID-19 Antibodies
 
In a pre-print draft of the 28-day, 9,785 patient RECOVERY trial (NCT04381936), treatment with Regeneron’s REGN-COV2 monoclonal antibody combination of casirivimab and imdevimab added to standard-of-care reduced all-cause mortality compared to placebo in hospitalized patients with COVID-19. In the placebo group, mortality was 30% in seronegative patients and 15% in seropositive patients. When all patients were compared regardless of antibody status, there was not a benefit with REGN-COV2 (20% vs 21%). However, in patients that were seronegative (had not developed antibodies), mortality was 24% with REGN-COV2 compared to 30% with placebo. Hospital stay was shorter (13 vs 17 days), the chance of being discharged greater (64% vs 58%) and use of mechanical ventilation or death was lower (30% vs 37%) in the seronegative group of patients. 
 
GSK and Vir announced that in the 29-day, 1,057 patient, Phase III, COMET-ICE trial (NCT04545060), treatment with VIR-7831 reduced the risk for hospitalization or death by 79% compared to placebo in patients with mild to moderate COVID-19 who are at high risk of progression to severe disease. 
 
COVID-19 Anti-inflammatories
 
Tofacitinib (Xeljanz, Pfizer) is a JAK1 and JAK3 inhibitor with partial JAK2 inhibition. It is theorized that JAK inhibition may reduce cytokine storm associated with COVID-19 infection and decrease viral reproduction. 

• In the 28-day, 289 patient, Phase III, STOP-COVID trial (NCT04469114), 18.1% of patients treated with tofacitinib plus standard of care required ventilation or died compared to 29% with standard of care alone in hospitalized Brazilian patients with COVID-19. Mortality was 2.8% with tofacitinib and 5.5% with placebo.​

COVID-19 Antivirals
 
Redhill Biopharm announced that in a 14-day, 40 patient, Phase IIa U.S. trial (NCT04414618), 50% of patients treated with opaganib did not require oxygen compared to 22% with placebo in hospitalized patients with severe COVID-19 pneumonia requiring supplemental oxygen. 86.4% in the opaganib group were discharged by Day 14 compared to 55.6% with placebo. Most patients received dexamethasone and/or remdesivir.
 
Redhill is evaluating the effect of opaganib on the need for mechanical ventilation in a 475 patient, Phase II/III trial (NCT04467840).