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

Sponsor
OPKO Health, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04551911
Collaborator
(none)
171
Enrollment
10
Locations
2
Arms
11.4
Actual Duration (Months)
17.1
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Rayaldee 30Mcg Extended-Release (ER) Capsule
  • Drug: Placebo
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
171 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Oct 26, 2020
Actual Primary Completion Date :
Oct 8, 2021
Actual Study Completion Date :
Oct 8, 2021

Arms and Interventions

ArmIntervention/Treatment
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
Other Names:
  • CTAP101 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.

    Drug: Placebo
    0Mcg Extended-Release (ER) Capsule

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Concentration of serum total 25-hydroxyvitamin D maintained at or above 50 ng/mL. [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1OPKO Investigative SiteSan FranciscoCaliforniaUnited States94127
    2OPKO Investigative SiteMiamiFloridaUnited States33173
    3OPKO Investigative SiteMiamiFloridaUnited States33185
    4OPKO Investigative SiteEvanstonIllinoisUnited States60201
    5OPKO Investigative SiteLaurelMarylandUnited States20723
    6OPKO Investigative SiteFarmington HillsMichiganUnited States48334
    7OPKO Investigative SiteJacksonMichiganUnited States49201
    8OPKO Investigative SiteSterling HeightsMichiganUnited States48312
    9OPKO Investigative SiteBrookhavenMississippiUnited States39601
    10OPKO Investigative SiteOmahaNebraskaUnited States68131

    Sponsors and Collaborators

    • OPKO Health, Inc.

    Investigators

    • Study Director: Akhtar Ashfaq, MD FACP FASN, OPKO Health, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    OPKO Health, Inc.
    ClinicalTrials.gov Identifier:
    NCT04551911
    Other Study ID Numbers:
    • CTAP101-CL-2014
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021