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 |
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Control
Standard care Definition of Standard care: All hospitalized patients received as best available therapy the same standard care, (per hospital protocol), of a combination of hydroxychloroquine (400 mg every 12 hours on the first day, and 200 mg every 12 hours for the following 5 days), azithromycin (500 mgorally for 5 days) and for patients with pneumonia and NEWS score≥5, a broad spectrum antibiotic (ceftriaxone2 g intravenously every 24 hours for 5 days) was added tohydroxychloroquine and azithromycin. Duration : 5 days | |
Participants | |
Randomized 76 participants (n1=50 / n2= 26) | |
Characteristics of participants N=76 Mean age : 53 45 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
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 stated 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. |