On 9 April 2020, the Institut Hospitalo-Universitaire (IHU) Méditerranée Infection, Marseille, released a brief summary (click > here) and a data table (click > here) from a non-comparative study conducted in persons who had a positive PCR test result for Sars-CoV-2, the virus responsible for covid-19, and were treated with hydroxychloroquine and azithromycin. These data follow the institute’s offer in late March to screen members of the public. The documents released do not describe the conditions to be met to qualify for screening or inclusion in the study.

Among the 38 617 persons who underwent PCR testing, 1061 of those with a positive PCR result for Sars-CoV-2 were included in this non-comparative study. They were 44 years old on average. About 46% were men. 95% of these 1061 patients had mild or no symptoms; 2.6% had severe symptoms. On chest CT scan, 34% had no signs of lung involvement, and 43% had signs which the authors described as limited. These 1061 patients were offered treatment with hydroxychloroquine and azithromycin for at least 3 days. These 1061 patients were followed up for at least 9 days. No details are provided on how patients were monitored for the serious cardiac adverse effects of the treatments, such as those identified by the Nice Regional Pharmacovigilance Centre (click > here). The authors considered that no "cardiac toxicity" was observed. The outcome was considered poor for 46 patients: 31 were hospitalised for 10 days or longer, 10 were admitted to intensive care, and 5 patients died, i.e. a mortality rate of 0.47% among the 1061 treated Sars-CoV-2-positive patients. The total number of patients hospitalised was not reported.

The disease course observed in this non-comparative study is consistent with what is known of Sars-CoV-2 infection. Serious complications are rare compared with the number of people who carry the virus but have only mild symptoms. Because this study had no control group, it is impossible to determine whether the treatment proposed had a positive or negative effect on the risk of progression to a severe form of the disease, nor to what extent this treatment contributed to the patients’ recovery, which is the most frequent outcome.

In Germany, the municipality of Gangelt was especially hard hit by the covid-19 epidemic. A representative sample of the general population was screened for antibodies to Sars-CoV-2 and for the virus by PCR. Partial results were released on 9 April 2020 in the form of a brief summary (click > here). About 14% of the 500 persons screened had developed such antibodies, while a PCR test detected the virus in 2% of the screened population. Based on these data and the number of covid-19-related deaths recorded in Gangelt, the case fatality rate was estimated to be about 0.37%, i.e. for every 1000 people infected, regardless of whether or not they have symptoms, about 4 persons die.

The results obtained in Marseille are consistent with those obtained in Gangelt. In most cases, Sars-CoV-2 causes mild symptoms, and patients recover from the infection without short-term complications. The results observed in Marseille can neither confirm nor rule out the benefit of any specific treatment for these patients.

©Prescrire 15 April 2020

See also:

• "Covid-19 and hydroxychloroquine: uncertainties and unanswered questions" 2 April 2020 > HERE
• "Covid-19 and hydroxychloroquine: caution" 30 March 2020 > HERE
• "Covid-19 and drug trials: what to make of the initial results?" 23 March 2020 > HERE

Source:

"Covid-19 et hydroxychloroquine : pas encore de résultats probants" Application Prescrire; 13 April 2020.

For more information (in French), see www.prescrire.org > Dans l'actualité

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