An Italian study carried out on a group of more than 3,000 patients, hospitalized for Covid-19, concluded that “the use of hydroxycholoroquine is associated with a 30% reduction in mortality”.
The research mobilized the main Italian hospitals, from north to south, including the university polyclinic “Agostino Gemelli“, where Roberto Cauda is the Director of the Department of Infectious Diseases,”our structure provided data for this retrospective multicenter study, it must be said that the clinical results on the reduction in mortality are consistent and in line with the other hospitals involved, there is a significant difference with the group treated with hydroxychloroquine – and concludes – but it is necessary that by the fall a serious meta-analysis on all the published studies on hydroxychloroquine be carried outCurrently, treatment is still blocked by European health regulatory agencies. To better understand how the research was carried out, we interviewed the study leader, Licia Iacoviello, Director of the Center for Epidemiology and Preventive Medicine at the University of Insubrie, Varèse, and Director of the Department of Epidemiology and Prevention at IRCCS Neuromed.
FS: How many patients are affected by your study?
LI: Our study (COVID-19 RISK and CORIST Collaboration Treatments) was carried out on a cohort of 3451 patients admitted to 33 clinical centers across Italy. This is a retrospective observational study.
FS: What structures are involved in collecting clinical data on patients?
LI: The study covered 33 structures, among the most recognized and important in Italy: Gemelli, Humanitas, San Matteo di Pavia, San Donato, San Gerardo di Monza, Spallanzani, Cotugno di Napoli, Miulli di Acquaviva delle Fonti, Monzino . University of Naples Federico II, Catania, Palermo, Cagliari, Chieti.
FS: It’s a study involving Italian hospital structures, from North to South. What conclusions did you reach?
LI: We have seen a 30% decrease in the risk of death in patients receiving hydroxychloroquine. The inverse association of hydroxychloroquine with in-hospital mortality was particularly evident in patients with elevated C-reactive protein upon entry.
FS: What do you mean by “they had a high level of C-reactive protein on entry”?
LI: C-reactive protein is a marker of inflammation. Having a high level of C-reactive protein when entering the hospital means that the Sars-Covid II infection has caused a significant inflammatory response. We believe that HCQ acts on this very component of the disease rather than inhibiting viral replication.
FS: What were the mortality rates in the hydroxychloroquine and control groups?
LI: The mortality rate of patients receiving hydroxychloroquine was 8.9 / 1000 patients / day, the mortality rate of those not receiving hydroxychloroquine was 15.7 / 1000 patients / day. Treatment was started on the first day of admission in most clinical centers, at a dose of 400 mg once a day, for an average duration of 10 days. 76% of patients were on HCQ treatment.
FS: Did the drug have statistically significant side effects?
LI: Our study did not collect information on adverse effects. However, the studies already published by the different centers participating in our study did not show significant cardiovascular clinical events, although there was an increase in the ECG QT. (sources: https://linkinghub.elsevier.com/retrieve/pii/S0167527320322233 and https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.048476)
FS: Is the prolongation of the heart rate (QT) seen on the electrocardiogram a serious adverse event or can it vary in magnitude?
LI: Exposure to a drug capable of inducing QT prolongation does not always lead to delayed ventricular repolarization and the development of serious complications in patients with long acquired QT interval appears be a rare occurrence.
FS: Are there some common medications that we use every day that can prolong the QT interval?
LI: Other commonly used drugs can prolong the QT interval, among the most well-known antipsychotics: like haloperidol, macrolide antibiotics like erythromycin and clarithromycin or quinolones like moxifloxacin.
FS: Could hydroxychloroquine have a significant impact on the treatment of Covid19?
LI: Our study is currently being reviewed in the European Journal of Internal Medicine. Its results can make an important contribution to the debate on the use of HCQ in COVID-19.
In an emergency situation such as a pandemic, the “gold standard” of intervention studies cannot be used and even randomized clinical trials (RCTs) cannot be performed under the best conditions.
Therefore, all data from both retrospective and RCTs should be considered, provided they are conducted appropriately. We believe that HCQ given early after the diagnosis of Covid-19 at low doses of 400 mg per day can be an effective and safe drug, inexpensive and easy to use, and not just in Italy.
FS: The main European medical agencies have blocked the use of hydroxychloroquine. There are currently many publications that support the efficacy and safety of hydroxychloroquine. What are the prospects for the fall?
LI: Other European studies already published have shown the effectiveness of treatment with HCQ in reducing the risk of mortality. In particular, a study carried out in France on more than 3,100 patients with COVID-19 showed that treatment with HCQ reduced the risk of hospitalization and death. A study conducted in Portugal suggests that the HCQ treatment protects against infection with SarCOV2.
Today’s debate is hampered by the difficulty that positive studies face in getting published.
In the fall, when these studies become available, we will have a clearer and more balanced picture of the effectiveness of HCQ, which could lead to the reopening of the prescription of the drug in low doses and in specific situations.