Trial Outcomes & Findings for Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 (NCT NCT04551911)
NCT ID: NCT04551911
Last Updated: 2024-05-28
Results Overview
Number and percentage of subjects with serum total 25-hydroxyvitamin D attained at or above 50 ng/mL at Visit 3 (Day 14)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
171 participants
Primary outcome timeframe
14 days
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
Rayaldee
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
86
|
|
Overall Study
COMPLETED
|
70
|
71
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
Rayaldee
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
10
|
|
Overall Study
Did not receive the study drug
|
3
|
4
|
Baseline Characteristics
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
Baseline characteristics by cohort
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 14.13 • n=99 Participants
|
43.8 years
STANDARD_DEVIATION 14.32 • n=107 Participants
|
43.0 years
STANDARD_DEVIATION 14.20 • n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Height
|
167.91 cm
STANDARD_DEVIATION 9.375 • n=99 Participants
|
167.34 cm
STANDARD_DEVIATION 8.747 • n=107 Participants
|
167.62 cm
STANDARD_DEVIATION 9.027 • n=206 Participants
|
|
Weight
|
81.05 kg
STANDARD_DEVIATION 18.730 • n=99 Participants
|
84.27 kg
STANDARD_DEVIATION 18.985 • n=107 Participants
|
82.71 kg
STANDARD_DEVIATION 18.860 • n=206 Participants
|
|
BMI
|
28.62 kg/m2
STANDARD_DEVIATION 5.521 • n=99 Participants
|
29.99 kg/m2
STANDARD_DEVIATION 5.913 • n=107 Participants
|
29.32 kg/m2
STANDARD_DEVIATION 5.746 • n=206 Participants
|
|
eGFR (glomerular filtration rate)
|
97.5 mL/min/1.73m^2
STANDARD_DEVIATION 16.89 • n=99 Participants
|
98.5 mL/min/1.73m^2
STANDARD_DEVIATION 18.62 • n=107 Participants
|
98.0 mL/min/1.73m^2
STANDARD_DEVIATION 17.74 • n=206 Participants
|
|
Serum total 25-hydroxyvitamin D (25D)
|
37.7 ng/mL
STANDARD_DEVIATION 12.15 • n=99 Participants
|
37.1 ng/mL
STANDARD_DEVIATION 15.60 • n=107 Participants
|
37.4 ng/mL
STANDARD_DEVIATION 13.98 • n=206 Participants
|
|
Flu-Pro Plus Aggregate Score
|
12.8 scores on a scale
STANDARD_DEVIATION 3.84 • n=99 Participants
|
12.5 scores on a scale
STANDARD_DEVIATION 3.91 • n=107 Participants
|
12.7 scores on a scale
STANDARD_DEVIATION 3.86 • n=206 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Per protocol population
Number and percentage of subjects with serum total 25-hydroxyvitamin D attained at or above 50 ng/mL at Visit 3 (Day 14)
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14).
|
51 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: Per protocol population
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).
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire.
|
9.8 days
Standard Deviation 8.15
|
10.8 days
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Per protocol population
The number of days to resolution of five symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering), as measured by the FLU-PRO Plus© questionnaire, with resolution defined as the first aggregate symptom score of ≤5 which is maintained for a minimum of three consecutive days, with no individual symptom score \>1
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Time to Resolution of COVID-19 Five Aggregated Symptoms
|
12.0 days
Standard Deviation 8.70
|
12.6 days
Standard Deviation 9.09
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Per protocol population
Resolution, defined as the first score of ≤5 which was maintained for a minimum of three consecutive days (without subsequent relapse), for the aggregate five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) and for each individual symptom, defined as a score of 0 or 1, as measured by the FLU-PRO Plus© questionnaire as of Day 10
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Number of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10
|
38 Number of participants
|
41 Number of participants
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Per protocol population
Resolution, defined as the first score of ≤5 which was maintained for a minimum of three consecutive days (without subsequent relapse), for the aggregate five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) and for each individual symptom, defined as a score of 0 or 1, as measured by the FLU-PRO Plus© questionnaire as of Day 10. Logistic regression with treatment as the main effect, and baseline aggregate symptom score, baseline 25D level, and body weight as covariates.
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Proportion of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10
|
0.618 Proportion
|
0.592 Proportion
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Per protocol population
Number and percentage of subjects with emergency room/urgent care visits
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Number of Participants With Emergency Room/Urgent Care Visits
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Per protocol population
Number and percentage of subjects with oxygen saturation below 94% (without supplemental oxygen)
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Per protocol population
Number and percentage of subjects with hospitalization
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Number of Participants With Hospitalizations
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Per protocol population
Number and percentage of subjects requiring mechanical ventilation
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Number of Participants With the Requirement for Mechanical Ventilation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Per protocol population
Number and percentage of subjects who died
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Number of Participant Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Per protocol population at-risk for improvement from baseline
Quality-of-Life (QOL) responses are based on the number of non-missing observations within individual QOL question and visit. Comparisons to baseline are assessed only for subjects who were at risk for improvement. Percentages for the comparisons to baseline are based on the number at-risk for improvement.
Outcome measures
| Measure |
Rayaldee
n=65 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=69 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
How much did your infection symptoms interfere with your usual activities today? · Missing
|
12 Participants
|
10 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Have you returned to your usual activities today? · Improved compared to baseline
|
26 Participants
|
34 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Have you returned to your usual health today? · Worsened compared to baseline
|
0 Participants
|
0 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Have you returned to your usual health today? · No charge from baseline
|
34 Participants
|
39 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Have you returned to your usual health today? · Missing
|
12 Participants
|
10 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Overall, how severe were your infection symptoms today? · Improved compared to baseline
|
47 Participants
|
48 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Overall, how severe were your infection symptoms today? · Worsened compared to baseline
|
1 Participants
|
1 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Overall, how severe were your infection symptoms today? · No charge from baseline
|
5 Participants
|
7 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Overall, how severe were your infection symptoms today? · Missing
|
12 Participants
|
10 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Overall, how were your infection symptoms today compared to yesterday? · Improved compared to baseline
|
45 Participants
|
50 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Overall, how were your infection symptoms today compared to yesterday? · Worsened compared to baseline
|
0 Participants
|
1 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Overall, how were your infection symptoms today compared to yesterday? · No charge from baseline
|
8 Participants
|
7 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Overall, how were your infection symptoms today compared to yesterday? · Missing
|
12 Participants
|
10 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
How much did your infection symptoms interfere with your usual activities today? · Improved compared to baseline
|
48 Participants
|
52 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
How much did your infection symptoms interfere with your usual activities today? · Worsened compared to baseline
|
1 Participants
|
0 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
How much did your infection symptoms interfere with your usual activities today? · No charge from baseline
|
4 Participants
|
5 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Have you returned to your usual activities today? · Worsened compared to baseline
|
0 Participants
|
0 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Have you returned to your usual activities today? · No charge from baseline
|
26 Participants
|
24 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Have you returned to your usual activities today? · Missing
|
12 Participants
|
10 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
In general, how would you rate your physical health today? · Improved compared to baseline
|
48 Participants
|
47 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
In general, how would you rate your physical health today? · Worsened compared to baseline
|
0 Participants
|
1 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
In general, how would you rate your physical health today? · No charge from baseline
|
5 Participants
|
10 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
In general, how would you rate your physical health today? · Missing
|
12 Participants
|
11 Participants
|
|
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
Have you returned to your usual health today? · Improved compared to baseline
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Per protocol population minus the number of participants with missing observations (4 participants in each Arm/Group).
Clinical course of COVID-19 as a function of Serum Total 25-hydroxyvitamin D concentrations of \<50 ng/mL, 50 to 100 ng/mL and \>100 ng/mL at Day 14, defined as the proportion of subjects in each treatment group with a total score of ≤5 for the selected five COVID-19 symptoms (trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering) using the FLU-PRO Plus© questionnaire. Results were similar for comparisons between treatment groups on Days 7, 14, 21 and 28, and only data for Day 14 is presented.
Outcome measures
| Measure |
Rayaldee
n=61 Participants
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=65 Participants
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period
Serum 25D Level <50 ng/mL · Yes
|
4 Participants
|
38 Participants
|
|
Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period
Serum 25D Level <50 ng/mL · No
|
6 Participants
|
17 Participants
|
|
Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period
Serum 25D Level 50 - 100 ng/mL · Yes
|
28 Participants
|
8 Participants
|
|
Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period
Serum 25D Level 50 - 100 ng/mL · No
|
8 Participants
|
2 Participants
|
|
Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period
Serum 25D Level >100 ng/mL · Yes
|
11 Participants
|
0 Participants
|
|
Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period
Serum 25D Level >100 ng/mL · No
|
4 Participants
|
0 Participants
|
Adverse Events
Rayaldee
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rayaldee
n=80 participants at risk
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=80 participants at risk
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
3.8%
3/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
2/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
Other adverse events
| Measure |
Rayaldee
n=80 participants at risk
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.
Rayaldee: 30 mcg Extended-Release (ER) Capsule
|
Placebo
n=80 participants at risk
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.
Placebo: 0 mcg Extended-Release (ER) Capsule
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
6.2%
5/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
3.8%
3/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Investigations
Transaminases increased
|
2.5%
2/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Investigations
Blood parathyroid hormone increased
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Investigations
Blood triglycerides increased
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Investigations
Electrocardiogram QRS complex abnormal
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Investigations
Haemoglobin decreased
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Nervous system disorders
Headache
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
2.5%
2/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
2/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Cardiac disorders
Bundle branch block right
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Psychiatric disorders
Stress
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
|
Vascular disorders
Hypotension
|
1.2%
1/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
0.00%
0/80 • 42 days
Analysis is for the safety population, subjects who received any amount of study drug treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place