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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rayaldee (Calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected With SARS-CoV-2 (REsCue)

Conditions
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Covid19, Coronavirus, SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: Rayaldee 30Mcg Extended-Release (ER) Capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 mcg calcifediol Extended-Release (ER) Capsule<br>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<br>* Rayaldee 30Mcg Extended-Release (ER) Capsule<br>* Other names: CTAP101 Capsule;|
| Placebo Comparator: 0 mcg calcifediol Extended-Release (ER) Capsule<br>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. | Drug: Placebo<br>* 0Mcg Extended-Release (ER) Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity and duration of disease as evidenced by COVID-19 symptoms using the FLU-PRO© questionnaire. | 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. | 42 days | 
| Concentration of serum total 25-hydroxyvitamin D maintained at or above 50 ng/mL. |  | 28 days |