Beijing / Bethesda / Foster City - The first results from three randomized studies on the antiviral remdesivir, on which the hopes for the treatment of COVID-19 are currently resting, vary.
In Chinese study no clear benefit could be shown for patients with severe illness. In study by the US National Institutes of Health with less seriously ill people, however, the time to recovery was shortened and the first results of study by the manufacturer show that 5-day treatment could be sufficient.
Only the results of the Chinese study are currently published. A team led by Bin Cao from the Clinic for Sino-Japanese Friendship in Beijing followed 237 patients in 2: 1 ratio to treatment with remdesivir in the “Ebola” dose (200 mg on day 1) at ten clinics in Hubei province of 100 mg on days 2 to 10) or randomized to placebo.
All patients had severe radiological examination with an oxygen saturation of 94 percent or less or PaO2 / FiO2 ratio of less than 300 mm Hg confirmed pneumonia (which is why concomitant treatment with lopinavir-ritonavir, interferons and corticosteroids was permitted).
The primary endpoint was an improvement in the clinical condition on scale from 1 (discharge) to 6 (death). According to the results that have now been communicated, this goal has not been clearly achieved. The publication in the Lancet (2020; DOI:) gives the hazard ratio for clinical improvement with 1.23.
With 95 percent confidence interval of 0.87 to 1.75, however, the significance level became missed. The results are therefore not absolutely reliable. It seems that the earlier treatment is started, the better results are: patients treated within 10 days of the onset of symptoms were more likely to recover. But the hazard ratio of 1.52 (0.95 to 2.43) also missed the level of significance. A chance result cannot be ruled out here either.
Originally, more patients were supposed to take part in the Chinese study. It was reported that it had to be ended prematurely because the epidemic in Hubei Province has now subsided and there have been no more serious cases of illness.
Participation in the Adaptive COVID-19 Treatment Trial (ACTT) was not limited to patients who were already in acute lung failure (ARDS). The study, in which 1,063 patients outside of China (with German participation) should take part, has not yet been completed. However, an interim evaluation last Monday showed that the patients treated with remdesivir (also in the “Ebola” regimen) had 31 percent significant (p