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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551911
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

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 disease Intervention/treatment Phase
Covid19 Coronavirus SARS-CoV-2 Infection Drug: Rayaldee 30Mcg Extended-Release (ER) Capsule Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : October 26, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Calcifediol

Arm Intervention/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 Name: 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




Primary Outcome Measures :
  1. 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.

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551911


Contacts
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Contact: Joel Melnick 305-575-4228 JMelnick@opko.com

Locations
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United States, California
OPKO Investigative Site Recruiting
San Francisco, California, United States, 94127
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
United States, Florida
OPKO Investigative Site Recruiting
Miami, Florida, United States, 33173
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
OPKO Investigative Site Recruiting
Miami, Florida, United States, 33185
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
United States, Illinois
OPKO Investigative Site Recruiting
Evanston, Illinois, United States, 60201
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
United States, Maryland
OPKO Investigative Site Recruiting
Laurel, Maryland, United States, 20723
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
United States, Michigan
OPKO Investigative Site Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
OPKO Investigative Site Recruiting
Jackson, Michigan, United States, 49201
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
OPKO Investigative Site Recruiting
Sterling Heights, Michigan, United States, 48312
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
United States, Mississippi
OPKO Investigative Site Recruiting
Brookhaven, Mississippi, United States, 39601
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
United States, Nebraska
OPKO Investigative Site Recruiting
Omaha, Nebraska, United States, 68131
Contact: Joel Melnick    305-575-4228    JMelnick@opko.com   
Sponsors and Collaborators
OPKO Health, Inc.
Investigators
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Study Director: Akhtar Ashfaq, MD FACP FASN OPKO Health, Inc.
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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT04551911    
Other Study ID Numbers: CTAP101-CL-2014
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents