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

NCT04551911 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2024-05-28

Study results available
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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.

Conditions

  • COVID-19
  • Coronavirus
  • SARS-CoV2 Infection

Interventions

DRUG

Rayaldee

30 mcg calcifediol Extended-Release (ER) Capsule

DRUG

Placebo

0 mcg calcifediol Extended-Release (ER) Capsule

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Akhtar Ashfaq, MD FACP FASN · OPKO Health, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2021-10-08
Completion
2021-10-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04551911 on ClinicalTrials.gov