Features of notified cases
Table 1 displays the general features of cases. Of 635 cases of
interest, 87% relied on spontaneous reporting. Seventy-two per cent
(72%) of cases were directly submitted to SEFV-H by healthcare
professionals, while 2% were reported by the public, 38% by the
pharmaceutical industry, and 4% came from medical literature reviews.
It is of note that a single case could have different origins. Most of
cases (76%) directly submitted to SEFV-H by healthcare professionals
were reported from a hospital.
Seventy-two per cent (72%) of cases were serious, and the clinical
outcome was fatal in 5% of cases. Fifty-six per cent (56%) of patients
were females. Patients’ age range and median age were 0,25 – 96 and 59
years, respectively. Sixty-three per cent (63%) of patients were
adults, and 31% were > 65 years. In the no-Covid cases,
the conditions for which HCQ was most frequently used were arthropathies
(34%) and lupus erythematosus (32%). In none of the notified cases,
neither prophylaxis nor treatment for malaria was the HCQ indication. In
41% of cases, the daily administered HCQ dose was lacking. Of the
remaining cases, in 33% medium daily doses (i. e. 400-600 mg/day) were
given, low doses in 20 %, and high doses in 6%. Of high daily doses,
100% were administered to Covid patients. The median total accumulated
dose was 2,800 mg, though there were significant differences between the
two groups. Most of patients (43%) received a low total HCQ dose. With
respect to total cumulative dosis, all the medium / high total HCQ doses
were given to no-Covid patients, since these patients were treated with
HCQ for longer.