COVID-19 Update for 4/9/2020

Remdesivir
 
Gilead is expanding the size of two remdesivir trials.

• Enrollment in NCT04292899 will increase from 400 to 2,400 patients with severe COVID-19 infections. The trial is still projected to be completed in May 2020 with a primary endpoint of improvement on day 14 as measured on a seven-point scale that runs from death to not hospitalized.
• Enrollment in NCT04292730 will increase from 600 to 1,600 patients with mild-to-moderate COVID-19 infections. The trial is also projected to be completed in May 2020 with a primary endpoint of improvement on day 11 as measured on a seven-point scale that runs from death to not hospitalized. ​

A study funded by Johnson and Johnson found that darunavir did not demonstrate in vitro antiviral activity against a clinical isolate of SARS-CoV-2, but remdesivir showed potent antiviral activity supporting the results found in an earlier study.
 
Hyperimmune Globulin
 
An alliance of plasma-derived drug manufacturers that include Takeda, CSL Behring, Biotest, Bio Products Laboratory, Octapharma and LFB have banded together to develop and manufacture a non-branded hyperimmune immunoglobulin. The group formed in order to speed development. The product will be an anti-COVID-19 polyclonal hyperimmune globulin (HIG). Because HIGs have been shown to be effective in the treatment of severe acute viral respiratory infections they are being tested as a treatment option for COVID-19. HIGs require plasma from patients that have recovered from COVID-19 or have been vaccinated (when a vaccine is available) to harvest COVID-19 antibodies that could potentially reduce illness severity or possibly prevent it.
 
In a ten patient Chinese case series, one 200 ml infusion of convalescent plasma infused 16.5 days after hospital admission improved or resolved symptoms within three days. All patients had severe pneumonia and confirmed to have a COVID-19 infection. All patients received antivirals and eight out of ten were receiving antibiotics and six out of ten were receiving methylprednisolone.
 
Favipiravir
 
Massachusetts General Hospital researchers are comparing favipiravir to standard of care in a 60 COVID-19 patient trial.
 
COVID-19 Vaccines
 
Inovio began clinical testing of INO-4800 in a 28-week, 40 volunteer, Phase I trial (NCT04336410) in April 2020. Healthy volunteers will receive two doses of the COVID-19 vaccine 4 weeks apart. Inovio anticipates having initial data available from the trial in late summer 2020.
 
Novavax is developing a COVID-19 vaccine based on recombinant protein nanoparticle technology to generate coronavirus spike (S) protein antigens. The company is using its saponin-based Matrix-M adjuvant to enhance immune responses. Novavax plans to initiate a 130 patient, Phase I trial for NVX-CoV2373 in mid-May 2020, with initial results expected in July 2020.