COVID-19 roundup: Qiagen ships diagnostic to China; plus Gilead starts own remdesivir trials and Ascletis clinical update
Qiagen said Wednesday it is seeking emergency FDA clearance for its coronavirus diagnostic. Separately, Gilead started a pair of Phase III trials of remdesivir to treat COVID-19, bringing the total number of trials testing the antiviral to five, and Ascletis announced clinical results for protease inhibitor Ganovo.
Qiagen N.V. (NYSE:QGEN; Xetra:QIA) said it will apply for emergency marketing authorization in the U.S., South Korea and China for a new version of its QIAstat-Dx respiratory panel that can test for the presence of SARS-CoV-2. The company said it has already shipped the panel to four hospitals in China for evaluation and is in the process of shipping to other regions including Southeast Asia and the Middle East.
In Europe, the panel will be available with CE-IVD marking. The Bichat-Claude Bernard Hospital in Paris is already evaluating the panel.
The test detects two of the virus' genes to provide “parallel tools for combined detection of the novel coronavirus with increased sensitivity," Qiagen said.
The panel is run on the FDA-cleared QIAstat-Dx syndromic testing system, which is widely deployed at hospitals and clinics. The system analyzes a clinical sample such as a swab in about an hour.
Gilead launches Phase III trials
Gilead Sciences Inc. (NASDAQ:GILD) started two Phase III trials of remdesivir, one which will evaluate the antiviral in 400 patients with severe disease compared with standard of care alone, and the other in 600 patients with moderate disease.
The trials are the first that the company itself is running to evaluate remdesivir for COVID-19; the announcement came a day after NIH said it enrolled the first patient in an adaptive trial testing the antiviral (see "U.S. Testing of Coronavirus Vaccine, Therapeutic Begin").
The primary endpoint of the study in patients with severe disease is normalization of fever and oxygen saturation; the primary endpoint of the other study is the number of patients discharged by day 14.
The trials are set to begin enrolling in March and will be conducted at medical centers primarily in Asian countries as well as other countries with high numbers of diagnosed COVID-19 cases.
Along with the NIH trial, the China-Japan Friendship Hospital is running two trials of remdesivir in Hubei; data are expected in April.
Patients receiving Ascletis' drug discharged
Ascletis Pharma Inc. (HKEX:1672) said the three COVID-19 patients who had received its Ganovo danoprevir plus ritonavir, a generic antiviral, in a Chinese clinical trial have been discharged from the hospital. The first patient was enrolled in the study on Feb. 17.
Detailed data were not disclosed; however, the company said the patients had satisfied discharge criteria under “Diagnosis and Treatment Program for Novel Coronavirus Infection (Trial Version 6),” issued by China's National Health Commission.
Ganovo received NMPA approval in 2018 to treat HCV.
Assistant Editor Sandi Wong contributed to this report