Clinical trial NCT04551911: Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Coronavirus
SARS-CoV2 Infection
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 or any substitutable FDA-authorized diagnostic test
3. 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)
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 (25D) (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.

Primary outcomes:
measure: Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14).
timeFrame: 14 days
measure: Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire.
timeFrame: 42 days
Secondary outcomes:
measure: Time to Resolution of COVID-19 Five Aggregated Symptoms
timeFrame: 42 days
measure: Number of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10
timeFrame: 10 days
measure: Proportion of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10
timeFrame: 10 days
measure: Number of Participants With Emergency Room/Urgent Care Visits
timeFrame: 42 days
measure: Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen)
timeFrame: 42 days
measure: Number of Participants With Hospitalizations
timeFrame: 42 days
measure: Number of Participants With the Requirement for Mechanical Ventilation
timeFrame: 42 days
measure: Number of Participant Deaths
timeFrame: 42 days
measure: Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
timeFrame: 14 days
measure: Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period
timeFrame: 14 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: OPKO Investigative Site
state: California
city: Miami
country: United States
facility: OPKO Investigative Site
state: Florida
city: Miami
country: United States
facility: OPKO Investigative Site
state: Florida
city: Evanston
country: United States
facility: OPKO Investigative Site
state: Illinois
city: Laurel
country: United States
facility: OPKO Investigative Site
state: Maryland
city: Farmington Hills
country: United States
facility: OPKO Investigative Site
state: Michigan
city: Jackson
country: United States
facility: OPKO Investigative Site
state: Michigan
city: Sterling Heights
country: United States
facility: OPKO Investigative Site
state: Michigan
city: Brookhaven
country: United States
facility: OPKO Investigative Site
state: Mississippi
city: Omaha
country: United States
facility: OPKO Investigative Site
state: Nebraska
Study officials:
affiliation: OPKO Health, Inc.
name: Akhtar Ashfaq, MD FACP FASN
role: STUDY_DIRECTOR
References: