Kaletra and Arbidol fail to demonstrate benefits in first large scale COVID-19 pneumonia trial

Below you will find a translation of a Chinese paper on the treatment of 134 confirmed cases of the new coronavirus SARS-CoV2 with COVID-19 viral pneumonia with Kaletra. It was translated by hand by a native speaker (see below) but Google translate does a pretty decent job if you prefer to read the original.

This is the largest observational study with results currently available and there were no benefits shown in patients given Kaltera . This is not a randomised study so there might be biases or differences between the people treated with Kaletra versus not, however, there is no benefit seen for any measure of efficacy (usefulness). This is the biggest study I can find. Perhaps they did not treat for long enough to show benefits – only the outcomes after 7 days of treatment were assessed. Perhaps a larger study might show a small impact, but it would be expected that if Kaletra worked as well for SARS-CoV-2 as it does for HIV we would have seen measurable differences. We didn’t.

There have been a few case reports suggesting that Kaletra is effective, but it is very hard to interpret them. Given this study failed to find any useful outcomes I don’t think anyone can claim that Kaletra works against coronavirus for the moment unless new results emerge. A randomised Chinese study should have results available by May or June.

Abstract

Aim: To evaluate the efficacy of lopinavir/ritonavir (Kaletra) and umifenovir (Arbidol) for the treatment of COVID-19 pneumonia

Methods: The clinical data of 134 patients diagnosed with COVID-19 pneumonia admitted to Shanghai Public Health Clinical Center from January 20 to February 6, 2020 were retrospectively analyzed. All 134 patients received recombinant human interferon α2b spray treatment and symptomatic supportive treatment. Among them, 52 patients took the antiviral drug lopinavir/ritonavir, 34 patients took the antiviral drug umifenovir, and 48 patients did not take any antiviral medication. The treatment effectiveness was compared between the three groups with a median treatment time of 7 days. The comparison between groups was performed using the Kruskal-Wallis test or Chi-square test.

Results: Of the 134 patients 69 were males and 65 were females. The age range 35-62 and the average age was 48.

The median time to return to normal temperature in the patients in both the lopinavir/ritonavir and umifenovir groups was 6 days, compared with 4 days in the control group, and the difference was not statistically significant ( χ 2 = 2.37 , P = 0.31).

The median time for viral nucleic acid testing to become negative was 7 days following treatment commencement for all three groups.

The rate of negative nucleic acid testing on day 7 amongst the groups was as follows: lopinavir/ritonavir 71.8%, rmifenovir 82.6%, and control 77.1%, with no statistical significance between groups (χ2=0.46, P=0.79).

On the 7th day after treatment commencement 22 patients (42.3%) in the lopinavir/ritonavir group, 12 patients (35.3%) in the umifenovir group, and 25 patients (52.1%) in the control group demonstrated progression on radiological imaging ( χ 2 = 2.38, P = 0.30).

Adverse reactions were observed in 9 cases (17.3%) for lopinavir/ritonavir, 3 cases (8.8%) for umifenovir and in 4 (8.3%) of control cases. There was no significant difference between the three groups ( χ 2 = 2.33, P = 0.33).

Conclusions: It has not been found that lopinavir/ritonavir or umifenovir have the effect of improving symptoms or shortening the time for respiratory specimen viral nucleic acid samples to test negative, so the effectiveness of these medications remains to be confirmed by further clinical studies.