1/ Our study (Coalition I) on HCQ and azithromycin for #Covid19 is out!
This study is the effort of an unprecedented collaboration (Coalition Covid19 Brasil) established between major Brazilian hospitals and research networks/Institutes.
nejm.org/doi/full/10.10…
This study is the effort of an unprecedented collaboration (Coalition Covid19 Brasil) established between major Brazilian hospitals and research networks/Institutes.
nejm.org/doi/full/10.10…
2/ Coalition I is one of nine RCTs on drug repurposing and long-term consequences of Covid19 being conducted by this research team.
I am honored and humbled to be part of this research effort in Brazil in such daring times.
I am honored and humbled to be part of this research effort in Brazil in such daring times.
3/ 667 hospitalized pts w mild to moderate Covid19 (pts on NIV/HF or MV were non-eligible) were randomized 1:1:1 to:
-HCQ + Azithromycin + Standard of care* (SoC)
-HCQ + SoC
-SoC
*SoC: antibiotics (~60%), oseltamivir (~25%), and steroids (~20%) w/o difference between groups.
-HCQ + Azithromycin + Standard of care* (SoC)
-HCQ + SoC
-SoC
*SoC: antibiotics (~60%), oseltamivir (~25%), and steroids (~20%) w/o difference between groups.
4/ The 1ary outcome was a 7-point ordinal scale that tells us how the pt is doing: from being at home w/o limitations (1)... to being on MV (6) or dead (7). At 15 days, the proportion of patients at home w/o limitations were:
-69% HCQ + Azithro + SoC
-64% HCQ + SoC
-68% SoC
-69% HCQ + Azithro + SoC
-64% HCQ + SoC
-68% SoC
5/ The proportional odds of having a higher score on the 7-point ordinal scale at 15 days was not affected by hydroxychloroquine alone (odds ratio [OR] 1.21 (0.69–2.11 [P=1.00])) or hydroxychloroquine plus azithromycin (OR, 0.99 (0.57–1.73 [P=1.00])), but...
6/ Note that the 95%CI are wide so that means that although the point estimates are similar between groups, we can not rule out the possibility that a difference not detected by our experiment does exist between groups and that ranges from benefit to harm from the treatment
7/ QTc prolongation & elevation of liver enzymes were more frequent in pts receiving HCQ alone or w azithromycin than in those not receiving either agent.
Coalition I included patients with a mean age of 50yo, ~60% males, 39% w hypertension, 19% w diabetes, and 15% obese.
Coalition I included patients with a mean age of 50yo, ~60% males, 39% w hypertension, 19% w diabetes, and 15% obese.
8/
The 2ary outcomes are consistent with the point estimates of the 1ary outcome.
Additionally, our findings add reproducibility to what other trials in different pop and different healthcare practices have shown.
The 2ary outcomes are consistent with the point estimates of the 1ary outcome.
Additionally, our findings add reproducibility to what other trials in different pop and different healthcare practices have shown.
