Coronavirus, COVID-19, SARS-CoV2 Infection
Conditions
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.
Interventions
DRUGRayaldee
30 mcg calcifediol Extended-Release (ER) Capsule
DRUGPlacebo
0 mcg calcifediol Extended-Release (ER) Capsule
Sponsors
OPKO Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14). | 14 days | Number and percentage of subjects with serum total 25-hydroxyvitamin D attained at or above 50 ng/mL at Visit 3 (Day 14) |
| Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire. | 42 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Number of Participants With Emergency Room/Urgent Care Visits | 42 days | Number and percentage of subjects with emergency room/urgent care visits |
| Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen) | 42 days | Number and percentage of subjects with oxygen saturation below 94% (without supplemental oxygen) |
| Number of Participants With Hospitalizations | 42 days | Number and percentage of subjects with hospitalization |
| Time to Resolution of COVID-19 Five Aggregated Symptoms | 42 days | 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 |
| Number of Participant Deaths | 42 days | Number and percentage of subjects who died |
| Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire | 14 days | 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. |
| Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period | 14 days | 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. |
| Number of Participants With the Requirement for Mechanical Ventilation | 42 days | Number and percentage of subjects requiring mechanical ventilation |
| 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 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 65 |
| 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 | 69 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive the study drug | 3 | 4 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 10 |
Baseline characteristics
| Characteristic | Rayaldee | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 14.13 | 43.8 years STANDARD_DEVIATION 14.32 | 43.0 years STANDARD_DEVIATION 14.2 |
| BMI | 28.62 kg/m2 STANDARD_DEVIATION 5.521 | 29.99 kg/m2 STANDARD_DEVIATION 5.913 | 29.32 kg/m2 STANDARD_DEVIATION 5.746 |
| eGFR (glomerular filtration rate) | 97.5 mL/min/1.73m^2 STANDARD_DEVIATION 16.89 | 98.5 mL/min/1.73m^2 STANDARD_DEVIATION 18.62 | 98.0 mL/min/1.73m^2 STANDARD_DEVIATION 17.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants | 56 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 13 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Flu-Pro Plus Aggregate Score | 12.8 scores on a scale STANDARD_DEVIATION 3.84 | 12.5 scores on a scale STANDARD_DEVIATION 3.91 | 12.7 scores on a scale STANDARD_DEVIATION 3.86 |
| Height | 167.91 cm STANDARD_DEVIATION 9.375 | 167.34 cm STANDARD_DEVIATION 8.747 | 167.62 cm STANDARD_DEVIATION 9.027 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 58 Participants | 65 Participants | 123 Participants |
| Serum total 25-hydroxyvitamin D (25D) | 37.7 ng/mL STANDARD_DEVIATION 12.15 | 37.1 ng/mL STANDARD_DEVIATION 15.6 | 37.4 ng/mL STANDARD_DEVIATION 13.98 |
| Sex: Female, Male Female | 38 Participants | 41 Participants | 79 Participants |
| Sex: Female, Male Male | 27 Participants | 28 Participants | 55 Participants |
| Weight | 81.05 kg STANDARD_DEVIATION 18.73 | 84.27 kg STANDARD_DEVIATION 18.985 | 82.71 kg STANDARD_DEVIATION 18.86 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 12 / 80 | 12 / 80 |
| serious Total, serious adverse events | 3 / 80 | 1 / 80 |
Outcome results
Primary
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)
Time frame: 14 days
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rayaldee | Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14). | 51 Participants |
| Placebo | Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14). | 10 Participants |
Primary
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).
Time frame: 42 days
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rayaldee | Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire. | 9.8 days | Standard Deviation 8.15 |
| Placebo | Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire. | 10.8 days | Standard Deviation 9.54 |
Secondary
Number of Participant Deaths
Number and percentage of subjects who died
Time frame: 42 days
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rayaldee | Number of Participant Deaths | 0 Participants |
| Placebo | Number of Participant Deaths | 0 Participants |
Secondary
Number of Participants With Emergency Room/Urgent Care Visits
Number and percentage of subjects with emergency room/urgent care visits
Time frame: 42 days
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rayaldee | Number of Participants With Emergency Room/Urgent Care Visits | 0 Participants |
| Placebo | Number of Participants With Emergency Room/Urgent Care Visits | 3 Participants |
Secondary
Number of Participants With Hospitalizations
Number and percentage of subjects with hospitalization
Time frame: 42 days
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rayaldee | Number of Participants With Hospitalizations | 0 Participants |
| Placebo | Number of Participants With Hospitalizations | 0 Participants |
Secondary
Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen)
Number and percentage of subjects with oxygen saturation below 94% (without supplemental oxygen)
Time frame: 42 days
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rayaldee | Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen) | 0 Participants |
| Placebo | Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen) | 1 Participants |
Secondary
Number of Participants With the Requirement for Mechanical Ventilation
Number and percentage of subjects requiring mechanical ventilation
Time frame: 42 days
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rayaldee | Number of Participants With the Requirement for Mechanical Ventilation | 0 Participants |
| Placebo | Number of Participants With the Requirement for Mechanical Ventilation | 0 Participants |
Secondary
Number of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10
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
Time frame: 10 days
Population: Per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rayaldee | 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 |
| Placebo | Number of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10 | 41 Number of participants |
Secondary
Proportion of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10
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.
Time frame: 10 days
Population: Per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rayaldee | 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 |
| Placebo | Proportion of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10 | 0.592 Proportion |
p-value: 0.7856Regression, Logistic
Secondary
Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period
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.
Time frame: 14 days
Population: Per protocol population minus the number of participants with missing observations (4 participants in each Arm/Group).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Placebo | 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 | 0 Participants |
| Placebo | 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 | 8 Participants |
| Placebo | 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 | 0 Participants |
| Placebo | 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 | 38 Participants |
| Placebo | 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 | 2 Participants |
| Placebo | 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 | 17 Participants |
Secondary
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
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.
Time frame: 14 days
Population: Per protocol population at-risk for improvement from baseline
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Rayaldee | 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 |
| Placebo | 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 | 5 Participants |
| Placebo | 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 |
| Placebo | 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 | 10 Participants |
| Placebo | 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 | 1 Participants |
| Placebo | 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 |
| Placebo | 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 | 34 Participants |
| Placebo | 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 | 10 Participants |
| Placebo | 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 | 48 Participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 | 10 Participants |
| Placebo | 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 | 10 Participants |
| Placebo | 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 | 7 Participants |
| Placebo | 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 | 50 Participants |
| Placebo | 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 | 24 Participants |
| Placebo | 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 | 1 Participants |
| Placebo | 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 | 39 Participants |
| Placebo | 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 | 7 Participants |
| Placebo | 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 | 10 Participants |
| Placebo | 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 | 10 Participants |
| Placebo | 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 | 52 Participants |
| Placebo | 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 | 11 Participants |
| Placebo | 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 | 0 Participants |
| Placebo | 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 | 47 Participants |
Secondary
Time to Resolution of COVID-19 Five Aggregated Symptoms
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
Time frame: 42 days
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rayaldee | Time to Resolution of COVID-19 Five Aggregated Symptoms | 12.0 days | Standard Deviation 8.7 |
| Placebo | Time to Resolution of COVID-19 Five Aggregated Symptoms | 12.6 days | Standard Deviation 9.09 |