Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study.
Level 4 - case-series / case-control
Uncontrolled observational study / case series without a comparator group
PubMed 32289548 · doi:10.1016/j.tmaid.2020.101663
What was done
An uncontrolled, non-comparative observational pilot study evaluated 80 inpatients with relatively mild COVID-19 treated with a combination of hydroxychloroquine and azithromycin for at least three days, with at least six days of follow-up. Assessed outcomes were clinical status, contagiousness via nasopharyngeal PCR and viral culture, and length of stay in the infectious disease unit.
What was found
Clinical improvement was reported in all patients except one 86-year-old patient who died and one 74-year-old patient who remained in intensive care. Nasopharyngeal viral load by PCR was negative in 83% of patients at Day 7 and 93% at Day 8. Viral cultures from respiratory samples were negative in 97.5% of patients at Day 5. Mean length of stay in the infectious disease unit was 5 days.
Why it matters
This early pilot study reported rapid viral clearance and clinical recovery in mild COVID-19 patients treated with hydroxychloroquine and azithromycin, which prompted international interest and subsequent randomized trials.
Limits
The study lacked a control or comparator group, making it impossible to separate the effect of the drug combination from natural viral clearance and recovery. The sample was limited to 80 relatively mildly infected patients with short follow-up (at least 6 days), and the abstract does not report baseline comorbidities, safety endpoints, or blinding.
Cited by
- supports An observational study of 80 COVID-19 patients treated with hydroxychloroquine and azithromycin showed clinical improvement in all but two patients, alongside reduced viral carriage.