Phase 2
Completed N=171
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
COVID · Coronavirus · SARS-CoV2 Infection
Source: ClinicalTrials.gov NCT04551911 ↗
Enrolled (actual)
171
Serious AEs
2.5%
Results posted
May 2024
Primary outcomePrimary: Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14). — 51; 10 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14). |
51; 10 | — |
| PRIMARY Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire. |
9.8; 10.8 | — |
| SECONDARY Time to Resolution of COVID-19 Five Aggregated Symptoms |
12.0; 12.6 | — |
| SECONDARY Number of Subjects Who Had an COVID-19 Five Aggregated Symptoms Score >5 at Baseline Who Experienced Symptom Resolution as of Day 10 |
38; 41 | — |
| SECONDARY 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; 0.592 | 0.7856 |
| SECONDARY Number of Participants With Emergency Room/Urgent Care Visits |
0; 3 | — |
| SECONDARY Number of Participants With Oxygen Saturation Below 94% (Without Supplemental Oxygen) |
0; 1 | — |
| SECONDARY Number of Participants With Hospitalizations |
0; 0 | — |
| SECONDARY Number of Participants With the Requirement for Mechanical Ventilation |
0; 0 | — |
| SECONDARY Number of Participant Deaths |
0; 0 | — |
| SECONDARY Severity of COVID-19 Illness as Evidenced by Quality of Life Measures Using the FLU-PRO Plus Questionnaire |
47; 48; 1; 1; 5; 7 | — |
| SECONDARY Resolution of Symptoms Based on FLU-PRO Plus© COVID-19 Five Symptom Aggregate Score Based on Serum 25D Level Over the Treatment Period |
4; 38; 6; 17; 28; 8 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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.
Exclusion Criteria
- Clinical signs indicative of severe or critical COVID-19 disease (eg, oxygen saturation 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
- 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.
Data sourced from ClinicalTrials.gov (NCT04551911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.