Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
This is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult subjects with mild to moderate COVID-19 who test positive for SARS-CoV-2 via nasopharynx swab and subsequent reverse transcription polymerase chain reaction (RT-PCR).
Arms and Interventions
|Experimental: 30 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.
Drug: Rayaldee 30Mcg Extended-Release (ER) Capsule
Rayaldee 30Mcg Extended-Release (ER) Capsule
|Placebo Comparator: 0 mcg calcifediol Extended-Release (ER) Capsule|
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.
0Mcg Extended-Release (ER) Capsule
Primary Outcome Measures
- Severity and duration of disease as evidenced by COVID-19 symptoms using the FLU-PRO© questionnaire. [42 days]
The FLU- PRO© questionnaire was specifically designed and validated to evaluate in clinical trials the presence, severity and duration of symptoms associated with viral infections. It contains 32 items (eg, felt hot, sweating, headache), grouped into 6 domains, that provide a comprehensive evaluation of such symptoms, using 5-point scales (values ranging from 0 to 4) with higher scores indicating worse symptoms.
- Concentration of serum total 25-hydroxyvitamin D maintained at or above 50 ng/mL. [28 days]
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.
Contacts and Locations
|1||OPKO Investigative Site||San Francisco||California||United States||94127|
|2||OPKO Investigative Site||Miami||Florida||United States||33173|
|3||OPKO Investigative Site||Miami||Florida||United States||33185|
|4||OPKO Investigative Site||Evanston||Illinois||United States||60201|
|5||OPKO Investigative Site||Laurel||Maryland||United States||20723|
|6||OPKO Investigative Site||Farmington Hills||Michigan||United States||48334|
|7||OPKO Investigative Site||Jackson||Michigan||United States||49201|
|8||OPKO Investigative Site||Sterling Heights||Michigan||United States||48312|
|9||OPKO Investigative Site||Brookhaven||Mississippi||United States||39601|
|10||OPKO Investigative Site||Omaha||Nebraska||United States||68131|
Sponsors and Collaborators
- OPKO Health, Inc.
- Study Director: Akhtar Ashfaq, MD FACP FASN, OPKO Health, Inc.
Study Documents (Full-Text)None provided.