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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
171
OPKO Investigative Site
San Francisco, California, United States
OPKO Investigative Site
Miami, Florida, United States
OPKO Investigative Site
Miami, Florida, United States
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
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
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
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
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OPKO Investigative Site
Evanston, Illinois, United States
OPKO Investigative Site
Laurel, Maryland, United States
OPKO Investigative Site
Farmington Hills, Michigan, United States
OPKO Investigative Site
Jackson, Michigan, United States
OPKO Investigative Site
Sterling Heights, Michigan, United States
OPKO Investigative Site
Brookhaven, Mississippi, United States
OPKO Investigative Site
Omaha, Nebraska, United States
Time frame: 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
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
Number of Participants With Emergency Room/Urgent Care Visits
Number and percentage of subjects with emergency room/urgent care visits
Time frame: 42 days
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
Number of Participants With Hospitalizations
Number and percentage of subjects with hospitalization
Time frame: 42 days
Number of Participants With the Requirement for Mechanical Ventilation
Number and percentage of subjects requiring mechanical ventilation
Time frame: 42 days
Number of Participant Deaths
Number and percentage of subjects who died
Time frame: 42 days
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
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