COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04551911

Joel Melnick

JMelnick@opko.com

2020-09-16

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: male or female ≥18 years of age confirmed within the past 3 days to have sars-cov-2 infection as evidenced by a positive nasopharyngeal swab test using rt-pcr confirmed to have only mild or moderate covid-19 based on a flu-pro© score of ≥ 1.5 for each of the chest/respiratory and body/systemic domains, and the absence of clinical signs indicative of more severe disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm) represents on self-assessment that the current covid-19 symptoms are not consistent with usual health and that they are the same or worse than on the previous day willing to limit the use of vitamin d therapies or supplements except for normally fortified food products (eg, milk) during the course of the 6-week study must demonstrate the ability to comply with all study requirements must be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation.

clinical signs indicative of severe or critical covid-19 disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm) pregnant or lactating women who are breastfeeding use of systemic glucocorticoid medications in the last six months recent history (previous 12 months) of primary hyperparathyroidism, kidney stones, hypercalciuria and/or hypercalcemia history of a chronic granuloma-forming disease (eg, sarcoidosis) history of tuberculosis or histoplasmosis history of chronic liver disease history (previous 12 months) of cardiac event indicative of chronic cardiovascular diseases including congestive heart failure, poorly controlled hypertension and arrhythmias history in the past five years of multiple myeloma or carcinoma of the breast, lung or prostate any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of vitamin d or 25-hydroxyvitamin d (eg, small bowel resection, history of crohn's disease or ulcerative colitis) ongoing treatment with thiazide diuretics history of hyperphosphatemia, hyperuricemia and gout renal impairment measured as egfr< 15 ml/min/1.73m² on serum creatinine in the last three months serum calcium ≥9.8 mg/dl in the last three months evidence of existing or impending dehydration known or suspected to have hypersensitivity to any of the constituents of the study drug currently participating in, or have participated in, an interventional/investigational study within 30 days prior to study screening.

2

OPKO Health, Inc.

18

100

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

171

Severity and duration of disease as evidenced by COVID-19 symptoms using the FLU-PRO© questionnaire.;Concentration of serum total 25-hydroxyvitamin D maintained at or above 50 ng/mL.

None

Phase 2

[{"arm_notes": "", "treatment_id": 244, "treatment_name": "Calcifediol", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]