COVID-19Phase 2NCT04551911
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
A Phase 2 study testing Rayaldee in people with COVID-19 and Coronavirus, run by OPKO Health, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronavirus, SARS-CoV2 Infection
- What is being tested?
- Rayaldee
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Nov 2020to 8 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age
- Confirmed within the past 3 days to have SARS-CoV-2 infection as evidenced by a positive nasopharyngeal swab test using RT-PCR or any substitutable FDA-authorized diagnostic test
- Confirmed to have only mild or moderate COVID-19 based on the first of the patient reported scores obtained during screening which meets the criterion a FLU-PRO Plus© score of ≥ 1.5 for each of the chest/respiratory and body/systemic domains, and the absence of clinical signs indicative of more severe disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm)
- Represents on self-assessment that the current COVID-19 symptoms are not consistent with usual health and that they are the same or worse than on the previous day
- Willing to limit the use of vitamin D therapies or supplements except for normally fortified food products (eg, milk) during the course of the 6-week study
- Must demonstrate the ability to comply with all study requirements
- Must be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation.
Who cannot join
- Clinical signs indicative of severe or critical COVID-19 disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm)
- Pregnant or lactating women who are breastfeeding
- Use of systemic glucocorticoid medications in the last six months
- Recent history (previous 12 months) of primary hyperparathyroidism, kidney stones, hypercalciuria and/or hypercalcemia
- History of a chronic granuloma-forming disease (eg, sarcoidosis)
- History of tuberculosis or histoplasmosis
Show all 17Show fewer
- History of chronic liver disease
- History (previous 12 months) of cardiac event indicative of chronic cardiovascular diseases including congestive heart failure, poorly controlled hypertension and arrhythmias
- History in the past five years of multiple myeloma or carcinoma of the breast, lung or prostate
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of vitamin D or 25-hydroxyvitamin D (25D) (eg, small bowel resection, history of Crohn's disease or ulcerative colitis)
- Ongoing treatment with thiazide diuretics
- History of hyperphosphatemia, hyperuricemia and gout
- Renal impairment measured as eGFR< 15 mL/min/1.73m² on serum creatinine in the last three months
- Serum calcium ≥9.8 mg/dL in the last three months
- Evidence of existing or impending dehydration
- Known or suspected to have hypersensitivity to any of the constituents of the study drug
- Currently participating in, or have participated in, an interventional/investigational study within 30 days prior to study screening.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
OPKO Investigative Site
Brookhaven, Mississippi, 39601
OPKO Investigative Site
Evanston, Illinois, 60201
OPKO Investigative Site
Farmington Hills, Michigan, 48334
OPKO Investigative Site
Jackson, Michigan, 49201
OPKO Investigative Site
Laurel, Maryland, 20723
OPKO Investigative Site
Miami, Florida, 33173
OPKO Investigative Site
Miami, Florida, 33185
OPKO Investigative Site
Omaha, Nebraska, 68131
OPKO Investigative Site
San Francisco, California, 94127
OPKO Investigative Site
Sterling Heights, Michigan, 48312
About this study
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)
This is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult subjects with mild to moderate COVID-19 who test positive for SARS-CoV-2.
- Conditions
- COVID-19, Coronavirus, SARS-CoV2 Infection
- Being tested
- Rayaldee, Placebo
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RayaldeeDrug
Also called CTAP101 Capsule
30 mcg calcifediol Extended-Release (ER) Capsule
PlaceboDrug
0 mcg calcifediol Extended-Release (ER) Capsule
| Study group | Role | What they receive |
|---|---|---|
| Rayaldee | Experimental | Subjects will be instructed to take a loading dose of 10 capsules (300 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Receives: Drug: Rayaldee |
| Placebo | Placebo comparator | Subjects will be instructed to take a loading dose of 10 capsules (0 mcg) of study drug per day on Days 1, 2 and 3 at bedtime after fasting for at least 3 hours following dinner, with any nonalcoholic liquid, by the oral route. On Days 4-27, subjects will take a maintenance dose of 2 capsules per day at bedtime unless otherwise directed. Patients were to remain fasted for at least 3 hours after administration of study drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 42 days
Secondary outcomes (10)
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
Measured: 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
Measured: 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.
Measured: 10 days
Number of Participants With Emergency Room/Urgent Care Visits
Number and percentage of subjects with emergency room/urgent care visits
Measured: 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)
Measured: 42 days
Number of Participants With Hospitalizations
Number and percentage of subjects with hospitalization
Measured: 42 days
Number of Participants With the Requirement for Mechanical Ventilation
Number and percentage of subjects requiring mechanical ventilation
Measured: 42 days
Number of Participant Deaths
Number and percentage of subjects who died
Measured: 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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start2 Nov 2020
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akhtar Ashfaq, MD FACP FASN, Study director, OPKO Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551911
- Sponsor's protocol ID
- CTAP101-CL-2014
- Status last verified
- May 2024
- First submitted
- 15 Sep 2020
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04551911
- Acronym / sponsor ID
- CTAP101-CL-2014
- Conditions
- COVID-19, Coronavirus, SARS-CoV2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rayaldee | Experimental | Drug: RayaldeeSubjects 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. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥18 years of age
- Confirmed within the past 3 days to have SARS-CoV-2 infection as evidenced by a positive nasopharyngeal swab test using RT-PCR or any substitutable FDA-authorized diagnostic test
- Confirmed to have only mild or moderate COVID-19 based on the first of the patient reported scores obtained during screening which meets the criterion a FLU-PRO Plus© score of ≥ 1.5 for each of the chest/respiratory and body/systemic domains, and the absence of clinical signs indicative of more severe disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm)
- Represents on self-assessment that the current COVID-19 symptoms are not consistent with usual health and that they are the same or worse than on the previous day
- Willing to limit the use of vitamin D therapies or supplements except for normally fortified food products (eg, milk) during the course of the 6-week study
Key exclusion criteria (17 listed)
- Clinical signs indicative of severe or critical COVID-19 disease (eg, oxygen saturation < 94% on room air or respiration rate > 30 bpm)
- Pregnant or lactating women who are breastfeeding
- Use of systemic glucocorticoid medications in the last six months
- Recent history (previous 12 months) of primary hyperparathyroidism, kidney stones, hypercalciuria and/or hypercalcemia
- History of a chronic granuloma-forming disease (eg, sarcoidosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RayaldeeAlso: CTAP101 Capsule30 mcg calcifediol Extended-Release (ER) Capsule | Drug | Rayaldee |
| Placebo0 mcg calcifediol Extended-Release (ER) Capsule | Drug | Placebo |
Primary outcome
Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14).
Time frame: 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.
Time frame: 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).
10 secondary outcomes
Time to Resolution of COVID-19 Five Aggregated Symptoms
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
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
Time frame: 10 days
Number of Participants With Emergency Room/Urgent Care Visits
Time frame: 42 days
Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen)
Time frame: 42 days
Number of Participants With Hospitalizations
Time frame: 42 days
Number of Participants With the Requirement for Mechanical Ventilation
Time frame: 42 days
Number of Participant Deaths
Time frame: 42 days
Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire
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
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akhtar Ashfaq, MD FACP FASN study director
OPKO Health, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rayaldee in people with COVID-19 and Coronavirus, run by OPKO Health, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14). (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.