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HCQ in COVID
HCQ in COVID
Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents 2020 March 20
Liu J, Cao R, Xu M, et al. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARSCoV-2 infection in vitro. Cell Discov 2020; 6:16
Objective
• To assess HCQ , either alone or with Azithromycin would be effective
in improving clinical status at 15 days after hospital admission due to
mild to moderate COVID 19
• Population: >18 years; admitted with suspected / confirmed COVID 19; O2
<4L/min
• Intervention: HCQ 400 mg BD for 7 days + standard care
HCQ 400 mg BD x 7 days + Azithromycin 500 mg OD x 7 days + standard care
• Control: Standard care
• Outcome: clinical status at 15 days – seven level ordinal score
• Time: March 29 2020 till June 2 2020; 15 days follow up
Was the study population clearly defined?
• Yes
Inclusion criteria
• Admitted with suspected/confirmed COVID 19
• Time between symptom onset and study enrolment ≤ 14 days.
Exclusion criteria
• Need for oxygen supplementation > 4L
• Use of high flow nasal catheter
• Use of non-invasive ventilation
• Use of mechanical ventilation
• Use hydroxochloroquine, chloroquine, azithromycin or another macrolide for
more than 24 hours
• History of severe ventricular cardiac arrhythmias or QTc≥480ms
• Known history of liver disease (liver cirrhosis), defined as the patient's report
or medical record of cirrhosis, esophageal varices, or clinical ascites;
• Renal dysfunction (estimated glomerular filtration rate [eGFR]
Were the outcome measures clearly defined?
• Yes
Primary Outcome
• Effect of HCQ/HCQ + Azithromycin/standard care in adult patients
with mild to moderate COVID 19 at the ordinal outcome at 15 days.
510
- after first 120 patients (60%, 19%, 7%, 1 %, 1%, 5%, 7%)
Power – 80 %
Odds ratio of 2 between two arms with a level of significance of 5%
Did the intervention and control groups start
with the same prognosis?
• Yes
Validity of the study
•
Study population: well defined
•
Outcomes: well defined
•
Randomization: done
•
Allocation concealment: done
•
Blinding: open labeled
•
Sample size calculation: adequate
•
Intention to treat analysis: no
•
Baseline characteristics: Similar
Results
Were all clinically relevant outcomes
considered?
• Yes
Were the study patients similar to the patients
in my practice?
• Yes
Conclusion
• No significant difference