RCT of 600 patients (400 symptomatic confirmed COVID-19 & 200 healthcare and household contacts)
Group 1: 100 pts with mild/moderate COVID-19 infection + 4d course of 400ug/kg Ivermectin qD (max dose 24mg) + standard of care
Group 2: 100 pts with mild/moderate COVID-19 infection + 400mg hydroxychloroquine BID x1d, then 200mg BID for 5d + standard of care
Group 3: 100 pts with severe COVID-19 + 4d course of 400ug/kg Ivermectin qD (max dose 24mg) + standard of care
Group 4: 100 pts with severe COVID-19 + 400mg hydroxychloroquine BID x1d, then 200mg BID for 5d + standard of care
Group 5: 100 healthcare and/or household contacts PPE + ivermectin 400mcg/kg x1 and repeated in 1 week
Group 6: 100 healthcare and/or household contacts PPE only
Excluded pregnant, lactating, and critical cases (respiratory failure requiring mechanical ventilation, presence of shock, other organ failure)
Mild Cases = Mild symptoms such as anosmia, loss of taste, fever, respiratory or GI tract symptoms
Moderate Cases = Symptoms such as fever, respiratory tract or GI symptoms + pneumonia manifestations on chest imaging
Severe Cases =
RR >30/min
O2 sat <93%
PaO2/FiO2 < 200
Lung infiltrates >50% of lung fields or rapid progression within 24 – 48hrs
Respiratory support (i.e. HFNC or NIV or IMV)
Primary Endpoint: Improvement in clinical/laboratory investigations and/or 2 consecutive negative PCR tests taken at least 48hours apart, and hospital LOS
Results:
In mild, moderate and severe COVID-19 patients there was improvement in lymphocyte count, CRP, ferritin, d-dimer and RT-PCR conversion days in Ivermectin group compared to hydroxychloroquine group after one week of treatment
Mortality:
Ivermectin Group 1: 0%
Hydroxychloroquine Group 2: 4%
Ivermectin Group 3: 2%
Hydroxychloroquine Group 4: 20%
Mean Hospital LOS:
Ivermectin Group 1: 5 +/- 1d
Hydroxychloroquine Group 2: 15 +/- 8d
Ivermectin Group 3: 6 +/- 1d
Hydroxychloroquine Group 4: 18 +/- 8d
Prevention of COVID-19 Infection in Healthcare or Household Contacts of COVID-19:
Ivermectin Group 5: 2%
No Ivermectin Group 6: 10%
Limitations:
Multiple primary endpoints with many being subjective/soft
Trial not registered at clinicaltrials.gov so can’t really check on what outcomes were originally set as primary outcomes and what was added or found through analysis
credited to Rebelem
Conclusion: Ivermectin in addition to standard care was more effective in treatment and prophylaxis compared to hydroxychloroquine in addition to standard care according to the authors. Without a placebo arm, we do not know if ivermectin is superior to standard care alone. Additionally, the methodology has concerning issues including multiple primary outcomes.
credited to rebelem
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