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

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551911
• Other study ID #: CTAP101-CL-2014
• Status: Completed
• Phase: Phase 2
• Start date: October 26, 2020
• Est. completion date: October 8, 2021

Study information

• Verified date: October 2021
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Covid19
• SARS-CoV-2 Infection

Intervention

Drug:
• Rayaldee 30Mcg Extended-Release (ER) Capsule
Rayaldee 30Mcg Extended-Release (ER) Capsule
• Placebo
0Mcg Extended-Release (ER) Capsule

Locations

Country	Name	City	State
United States	OPKO Investigative Site	Brookhaven	Mississippi
United States	OPKO Investigative Site	Evanston	Illinois
United States	OPKO Investigative Site	Farmington Hills	Michigan
United States	OPKO Investigative Site	Jackson	Michigan
United States	OPKO Investigative Site	Laurel	Maryland
United States	OPKO Investigative Site	Miami	Florida
United States	OPKO Investigative Site	Miami	Florida
United States	OPKO Investigative Site	Omaha	Nebraska
United States	OPKO Investigative Site	San Francisco	California
United States	OPKO Investigative Site	Sterling Heights	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Concentration of serum total 25-hydroxyvitamin D maintained at or above 50 ng/mL.		28 days