NCT04551911Phase 2Completed

Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-10-08Actual

Enrollment · participants171Actual

Source updated2024-05-28Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

COVID-19; Coronavirus; SARS-CoV2 Infection

Treatments or interventions studied

RayaldeeDrugAlso known as CTAP101 Capsule
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Concentration of Serum Total 25-hydroxyvitamin D Attained at or Above 50 ng/mL at Visit 3 (Day 14).; description: Number and percentage of subjects with serum total 25-hydroxyvitamin D attained at or above 50 ng/mL at Visit 3 (Day 14); timeFrame: 14 days; measure: Resolution of COVID-19 Five Aggregated Symptoms Using the Flu-PRO Plus© Questionnaire.; description: 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).; timeFrame: 42 days

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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