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

NCT04551911 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CTAP101-CL-2014
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 10

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.

Conditions

COVID-19; Coronavirus; SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (2)

• Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14).

  Number and percentage of subjects with serum total 25-hydroxyvitamin D attained at or above 50 ng/mL at Visit 3 (Day 14)

  14 days

• Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire.

  The FLU- PRO Plus© 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. The number of days to resolution of the selected five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering), defined as a reduction in the aggregate symptom score recorded on Day 0 (prior to study drug initiation) by the FLU-PRO Plus© questionnaire to or below 5 for a minimum of three consecutive days. Flu-PRO Plus© was created and supplied by Dr. John Powers and Leidos Biomedical, and the National Institute for Allergy and Infectious Diseases (NIAID).

  42 days

Secondary Outcomes (10)

• Time to Resolution of COVID-19 Five Aggregated Symptoms

  42 days

• Number of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10

  10 days

• Proportion of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10

  10 days

• Number of Participants With Emergency Room/Urgent Care Visits

  42 days

• Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen)

  42 days

Study Arms (2)

Rayaldee

EXPERIMENTAL

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. Patients were to remain fasted for at least 3 hours after administration of study drug.

Drug: Rayaldee

Placebo

PLACEBO COMPARATOR

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. Patients were to remain fasted for at least 3 hours after administration of study drug.

Drug: Placebo

Interventions

Rayaldee DRUG

30 mcg calcifediol Extended-Release (ER) Capsule

Also known as: CTAP101 Capsule

Rayaldee

Placebo DRUG

0 mcg calcifediol Extended-Release (ER) Capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or any substitutable FDA-authorized diagnostic test
• Confirmed to have only mild or moderate COVID-19 based on the first of the patient reported scores obtained during screening which meets the criterion a FLU-PRO Plus© 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.

You may not qualify if:

• 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 (25D) (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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (10)

OPKO Investigative Site

San Francisco, California, 94127, United States

Location

OPKO Investigative Site

Miami, Florida, 33173, United States

Location

OPKO Investigative Site

Miami, Florida, 33185, United States

Location

OPKO Investigative Site

Evanston, Illinois, 60201, United States

Location

OPKO Investigative Site

Laurel, Maryland, 20723, United States

Location

OPKO Investigative Site

Farmington Hills, Michigan, 48334, United States

Location

OPKO Investigative Site

Jackson, Michigan, 49201, United States

Location

OPKO Investigative Site

Sterling Heights, Michigan, 48312, United States

Location

OPKO Investigative Site

Brookhaven, Mississippi, 39601, United States

Location

OPKO Investigative Site

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Calcifediol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

A caveat in the analysis is the variability of 25D at baseline. The study is also limited by timing differences between the onset of symptoms and diagnosis of COVID-19, and between COVID-19 diagnosis and the initiation of treatment among participants.

Results Point of Contact

• Title: OPKO Health Inc
• Organization: OPKO Health Inc

contact@opko.com

305-575-4100

Study Officials

• Akhtar Ashfaq, MD FACP FASN

  OPKO Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 16, 2020
• Study Start: November 2, 2020
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)