Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
Covid19, Coronavirus, SARS-CoV-2 Infection
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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.
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 (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.
Sites / Locations
- OPKO Investigative Site
- OPKO Investigative Site
- OPKO Investigative Site
- OPKO Investigative Site
- OPKO Investigative Site
- OPKO Investigative Site
- OPKO Investigative Site
- OPKO Investigative Site
- OPKO Investigative Site
- OPKO Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
30 mcg calcifediol Extended-Release (ER) Capsule
0 mcg calcifediol Extended-Release (ER) Capsule
Subjects will be instructed to take a loading dose of 10 capsules (300 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed.
Subjects will be instructed to take a loading dose of 10 capsules (0 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed.