By vgreene, 28 October, 2021 27 pts died 39 w high dose CQ 15 w low dose CQ 15 pts developed QTc interval 500 msec 19 w high dose CQ 11 w low dose CQ 2 pts had ventricular tachycardia w 2 deaths
By vgreene, 28 October, 2021 High dose CQ group halted early due to safety concerns and all pts converted to low dose CQ small sample size in low dose CQ group limits efficacy analysis but resp secretions negative at day 4 in 6 of 27 tested pts
By vgreene, 28 October, 2021 Double blind RCT 81 hospitalized pts mean age 51y 77 w confirmed COVID 19 at enrollment randomized 1 1 to high dose CQ 600 mg bid x10 days or low dose CQ 450 mg bid x1 day then 450 mg daily x4 days all pts received AZ 500 mg daily x5 days 90 received osel
By vgreene, 28 October, 2021 Study considerations small sample size interim safety data limited efficacy analysis high dose CQ arm had older pts w more comorbidities no contemporaneous control group
By vgreene, 28 October, 2021 KEY FINDINGS higher CQ doses not recommended for critically ill pts due to safety concerns
By vgreene, 28 October, 2021 Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 SARS CoV 2 Infection A Randomized Clinical Trial
By vgreene, 28 October, 2021 FDA MedWatch Hydroxychloroquine or Chloroquine for COVID 19 Drug Safety Communication FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems see FDA alert
