French researchers prospectively monitored the heart rhythms of 41 hospitalized COVID-19 patients being treated with lopinavir and ritonavir and found that 22% (nine patients) experienced bradycardia at least 48 hours after initiating the drugs.
Fujita Health University researchers announced that in an 89 patient trial, treatment with favipiravir did not improve COVID-19 symptoms compared to placebo in patients with early-stage COVID-19.
In an observational trial, University of Michigan researchers examined outcomes in 154 mechanically ventilated patients with severe COVID-19 that received tocilizumab to those not receiving tocilizumab. Around a quarter of patients in each group received hydroxychloroquine and/or a corticosteroid and 3% received remdesivir. Patients that received tocilizumab were younger (55 vs. 60), less likely to have chronic pulmonary disease (10% vs. 28%), and lower D-dimer values (2.4 vs. 6.5 mg/dL). During a 47-day follow-up, tocilizumab patients had a higher rate of superinfections (54% vs. 26%), but a lower 28-day mortality rate (18% vs. 36%).
Moderna completed enrollment in a 600 patient, Phase II trial (NCT04405076) in early July. Patients were given a low dose (50 micrograms), high dose (100 micrograms) or placebo. Half of the patients enrolled in the trial are older than 55. Moderna plans to initiate a 30,000 patient, NIAID sponsored, Phase III trial on July 27, 2020 using the 100 mcg vaccine dose.
The FDA granted Fast Track status to two vaccines in the BioNTech and Pfizer COVID-19 BNT162 program. A Pfizer funded 30,000 patient, Phase III trial is expected to begin in late July or early August.
NIAID has established the COVID-19 Prevention Trials Network (COVPN), as part of Operation Warp Speed. The Network is designed to accelerate the development of vaccines and monoclonal antibodies for the prevention of COVID-19. COVPN is composed of four clinical trial networks, three that had focused on HIV/AIDS and a fourth targeting the development of vaccines and treatments for infectious diseases.
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