REsCue Trial: Randomized Controlled Clinical Trial with Extended-Release Calcifediol in Symptomatic COVID-19 Outpatients

ABSTRACT:

Objective

This double-blind RCT investigated raising serum 25-hydroxyvitamin D (25D) with extended-release calcifediol (ERC) on time to symptom resolution in mild to moderate COVID-19.

Research Methods & Procedures

COVID-19 outpatients received oral ERC (300 mcg on Days 1-3 and 60 mcg on Days 4-27) or placebo (NCT04551911). Symptoms were self-reported daily. Primary endpoints were raising 25D to ≥50 ng/mL and decreasing resolution time for five aggregated symptoms (three respiratory).

Results

171 subjects were randomized, 160 treated and 134 (65 ERC, 69 placebo) retained. Average age was 43 (range: 18-71), 59% female, mean baseline 25D was 37±1 (SE) ng/mL. In the full analysis set (FAS), 81% of ERC subjects achieved 25D levels of ≥50 ng/mL versus 15% with placebo

SUBMITTER: Bishop C 

PROVIDER: S-EPMC9639413 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature