Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19

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 or any substitutable FDA-authorized diagnostic test
• Confirmed to have only mild or moderate COVID-19 based on the first of the patient reported scores obtained during screening which meets the criterion a FLU-PRO Plus© 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.

Exclusion criteria

• 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 (25D) (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.