Azithromycin/dexamethasone/prednisone

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

In a report, 3 patients (1 man and 2 women) aged 39−55 years were described, who exhibited lack of efficacy during off label treatment with azithromycin for severe acute respiratory syndrome coronavirus disease-2 (SARS-CoV-2) infection or developed rebound effect in the form of worsening of subacute thyroiditis (SAT) following dose reduction or withdrawal of prednisone for (SAT). Additionally, one these three patient received off label treatment with dexamethasone for SARS-CoV-2 infection [not all dosages stated; routes and duration of treatments to reactions onsets not stated].

The 50-year-old man (case 1), presented for neck pain, palpable hard neck tumour, fever and headaches occurring from 6 October 2020. He received empirical treatment with azithromycin; however no significant relief was noted. Further, he reported non-productive cough and increased fever. Therefore, his treatment was changed, and he received empirical treatment with amoxicillin. The following day malaise, loss of smell and retrosternal discomfort was noted. He was hospitalised and was diagnosed with SARS-CoV-2 infection. He was discharged and started receiving off label treatment with azithromycin 250 mg/day for SARS-CoV-2; however no improvement was noted. The dose of azithromycin was increased to 500 mg/day, and he reported worsening of fever, cough, headache, insomnia and neck pain with palpable hard neck tumour indicating lack of efficacy. Thereafter, he started receiving off label treatment with dexamethasone 4 mg/day for SARS-CoV-2 infection. Dexamethasone was gradually reduced and eventually discontinued. A significant improvement in his condition was noted. Further, his symptoms reappeared with a palpable hard tumour on right side of neck, insomnia, headache, tachycardia and increased BP up to 170/115mm Hg. He started receiving treatment with cefuroxime due to recurrence of fever; however fever persisted along with neck pain and palpable hard neck tumour for over a month. Further, he was diagnosed with SAT and started receiving treatment with prednisone. His symptoms reduced rapidly and the inflammatory parameter normalised gradually. The dose of prednisone was gradually reduced and eventually discontinued. In a 10 months follow-up, no recurrence of symptoms was observed. His HLA profile demonstrated strong susceptibility to SAT with HLA-B*35 homozygosity.

The 39-year-old woman (case 2), was diagnosed with COVID-19 in December 2020. Five weeks following diagnosis of COVID-19, a fever and malaise recurred along with severe neck pain, tachycardia, insomnia and tremor. She was diagnosed with SAT. She started receiving treatment with prednisone 60mg for SAT and a slight relief in the symptoms was noted. Several attempts were made to reduce prednisone dose; however, exaggeration of symptoms and worsening of SAT was noted on every attempt to reduce prednisone dose indicating rebound effect in the form of worsening of SAT. The dose of prednisone was reduced very slowly under strict monitoring and complete prednisone withdrawal was successful after four months of treatment. Further, at a 8 months follow-up no recurrence was observed.

The 55-year-old woman (case 3), was diagnosed with SAT in November 2020. She started receiving treatment with prednisone for SAT. Further, she was diagnosed with SARS-CoV-2 infection. Her treatment with prednisone was continued throughout SARS-CoV-2. She completed one month therapy with prednisone, and the ESR was 4 mm/h and thyroid US pattern was normal. After 7 days of prednisone withdrawal, the symptoms recurred starting with neck pain and gradual worsening of symptoms and SAT recurrence was diagnosed indicating rebound effect in the form of worsening of SAT. Her treatment with prednisone was restarted.