Trial NCT04366908
Publication Entrenas Castillo M, J Steroid Biochem Mo (2020) (published paper)

Funding: Public/non profit (Maimónides Biomedical Research Institute of Córdoba)
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Single center / Spain
Follow-up duration (days): 28
Inclusion criteria
  • Age ≥ 18 and < 90 years
    PCR confirmed diagnosis of COVID-19
    Radiological image compatible with inflammatory pleuropulmonary exudate
    Signature of direct or delegated informed consent
Exclusion criteria
  • Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages
    Intolerance or allergy to Calcifediol or its components
    Pregnancy
Interventions
Treatment
Calcifediol
532 mcg orally on day 1, followed by 266 mcg on days 3 and 7 then weekly until discharge or ICU admission
Control
Standard care

Participants
Randomized
participants :
Calcifediol=50
Standard care=26
Characteristics of participants
N= 76
Mean age : NR
45 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Proportion of subjects who enter the ICU; Proportion of subjects who die (Time Frame: At day 28)
In the report
Rate of ICU admission and death
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published report of the pilot study (journal pre-proof), the study registry was used in data extraction. There is no change from the trial registration in the intervention and control treatments. Pre-specified secondary outcomes included in the registry were not reported. Serum 25OHD concentrations at baseline or during treatment are not available. There were 2 deaths (control arm) out of 80 participants. It was not possible to find the exact timepoint for discharge, though not extracted.