"Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study".
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 32871238 · doi:10.1016/j.jsbmb.2020.105751
What was done
A parallel pilot randomized trial at a single university hospital in Spain evaluated 76 consecutive hospitalized patients with PCR-confirmed SARS-CoV-2 viral pneumonia and CURB-65 score > 1. All patients received standard care consisting of hydroxychloroquine and azithromycin. Patients were randomized in a 2:1 ratio to receive oral calcifediol (0.532 mg on admission, 0.266 mg on days 3 and 7, then weekly; n = 50) or no calcifediol (n = 26). The evaluated outcomes were ICU admission rate and in-hospital mortality.
What was found
ICU admission occurred in 1 of 50 patients (2%) in the calcifediol group compared to 13 of 26 patients (50%) in the control group (p < 0.001). The univariate odds ratio for ICU admission with calcifediol was 0.02 (95% CI 0.002 to 0.17), and the multivariate odds ratio adjusted for hypertension and type 2 diabetes was 0.03 (95% CI 0.003 to 0.25). Zero patients died in the calcifediol group (0/50), whereas 2 of 26 patients (7.7%) died in the untreated group (both among the 13 admitted to the ICU).
Why it matters
This pilot trial was among the earliest randomized studies to suggest that rapid administration of calcifediol might prevent severe respiratory deterioration in hospitalized COVID-19 patients.
Limits
The study had a very small sample size (n = 76) at a single center, resulting in wide confidence intervals. The text contains conflicting masking descriptions ("open label, double-masked"). Background standard care relied on early-pandemic regimens (hydroxychloroquine and azithromycin) that were later discontinued, and baseline vitamin D levels were not reported in the abstract.
Cited by
- supports In a Spanish randomized controlled trial led by Marta Castillo, 2% of patients treated with calcifediol were admitted to the ICU compared to 50% in the placebo group.