Trial *
Publication Elamir YM, Bone, 2021 (published paper)
Dates: 2020-09-01 to 2020-12-30
Funding: Not reported/unclear
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / USA Follow-up duration (days): 30 | |
| Inclusion criteria | Hospitalized patients with COVID-19 |
| Exclusion criteria | Admitted directly to the intensive care unit (ICU); hypercalcemia and/or hyperphosphatemia on admission blood tests; untreated disorders of calcium metabolism including hyperparathyroidism, hypoparathyroidism, chronic renal insufficiency with glomerular filtration rate < 30 ml/min; prescribed calcitriol for any reason outside of the study. |
| Interventions | |
| Treatment
Calcitriol 0.5 mcg once a day for 14 days or until discharge, whichever came first |
|
| Control
Standard care ( / ) Definition of Standard care: The remainder of the patient’s care was determined by the primary team and may include treatment with remdesivir (200 mg for one day followed by 100mg for 4 days), dexamethasone (6 mg daily for 10 days), or convalescent plasma, as well as supplemental O2. | |
| Participants | |
| Randomized 50 participants (n1=25 / n2= 25) | |
| Characteristics of participants N=50 Mean age : 66.5 25 males Severity : Mild: n=24 / Moderate: n=20/ Severe: n=6 Critical: n=0 | |
| Primary outcome | |
| In the register NR | |
| In the report Outcomes of the effectiveness of calcitriol in the treatment of COVID19 included oxygen requirements, length of hospital stay, need for ICU admission, mortality, and readmission. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| 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 | Only the published article was used in data extraction and assessment of risk of bias. No registry, protocol or statistical analysis plan was available. |