- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04551911
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
October 14, 2021 updated by: OPKO Health, Inc.
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)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
171
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94127
- OPKO Investigative Site
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Florida
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Miami, Florida, United States, 33173
- OPKO Investigative Site
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Miami, Florida, United States, 33185
- OPKO Investigative Site
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Illinois
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Evanston, Illinois, United States, 60201
- OPKO Investigative Site
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Maryland
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Laurel, Maryland, United States, 20723
- OPKO Investigative Site
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Michigan
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Farmington Hills, Michigan, United States, 48334
- OPKO Investigative Site
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Jackson, Michigan, United States, 49201
- OPKO Investigative Site
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Sterling Heights, Michigan, United States, 48312
- OPKO Investigative Site
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Mississippi
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Brookhaven, Mississippi, United States, 39601
- OPKO Investigative Site
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Nebraska
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Omaha, Nebraska, United States, 68131
- OPKO Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
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Rayaldee 30Mcg Extended-Release (ER) Capsule
Other Names:
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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.
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0Mcg Extended-Release (ER) Capsule
|
What is the study measuring?
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.
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.
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42 days
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Concentration of serum total 25-hydroxyvitamin D maintained at or above 50 ng/mL.
Time Frame: 28 days
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Akhtar Ashfaq, MD FACP FASN, OPKO Health, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2020
Primary Completion (Actual)
October 8, 2021
Study Completion (Actual)
October 8, 2021
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 16, 2020
Study Record Updates
Last Update Posted (Actual)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 14, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcifediol
Other Study ID Numbers
- CTAP101-CL-2014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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