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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551911
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 16, 2020
Last Update Posted Date October 15, 2021
Actual Study Start Date  ICMJE October 26, 2020
Actual Primary Completion Date October 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • Severity and duration of disease as evidenced by COVID-19 symptoms using the FLU-PRO© questionnaire. [ Time Frame: 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. [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Severity and duration of disease as evidenced by COVID-19 symptoms using the LUPRO © questionnaire [ Time Frame: 24 days ]
  • Attainment and maintenance of serum total 25D levels at or above 50 ng/mL [ Time Frame: 24 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
Official Title  ICMJE 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)
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Coronavirus
  • SARS-CoV-2 Infection
Intervention  ICMJE
  • Drug: Rayaldee 30Mcg Extended-Release (ER) Capsule
    Rayaldee 30Mcg Extended-Release (ER) Capsule
    Other Name: CTAP101 Capsule
  • Drug: Placebo
    0Mcg Extended-Release (ER) Capsule
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2021)
171
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
160
Actual Study Completion Date  ICMJE October 8, 2021
Actual Primary Completion Date October 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female ≥18 years of age
  2. Confirmed within the past 3 days to have SARS-CoV-2 infection as evidenced by a positive nasopharyngeal swab test using RT-PCR
  3. 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)
  4. 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
  5. 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
  6. Must demonstrate the ability to comply with all study requirements
  7. 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:

  1. Clinical signs indicative of severe or critical COVID-19 disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm)
  2. Pregnant or lactating women who are breastfeeding
  3. Use of systemic glucocorticoid medications in the last six months
  4. Recent history (previous 12 months) of primary hyperparathyroidism, kidney stones, hypercalciuria and/or hypercalcemia
  5. History of a chronic granuloma-forming disease (eg, sarcoidosis)
  6. History of tuberculosis or histoplasmosis
  7. History of chronic liver disease
  8. History (previous 12 months) of cardiac event indicative of chronic cardiovascular diseases including congestive heart failure, poorly controlled hypertension and arrhythmias
  9. History in the past five years of multiple myeloma or carcinoma of the breast, lung or prostate
  10. 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)
  11. Ongoing treatment with thiazide diuretics
  12. History of hyperphosphatemia, hyperuricemia and gout
  13. Renal impairment measured as eGFR< 15 mL/min/1.73m² on serum creatinine in the last three months
  14. Serum calcium ≥9.8 mg/dL in the last three months
  15. Evidence of existing or impending dehydration
  16. Known or suspected to have hypersensitivity to any of the constituents of the study drug
  17. Currently participating in, or have participated in, an interventional/investigational study within 30 days prior to study screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04551911
Other Study ID Numbers  ICMJE CTAP101-CL-2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OPKO Health, Inc.
Study Sponsor  ICMJE OPKO Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Akhtar Ashfaq, MD FACP FASN OPKO Health, Inc.
PRS Account OPKO Health, Inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP