NCT04551911

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Rayaldee	30 mcg calcifediol Extended-Release (ER) Capsule
DRUG	Placebo	0 mcg calcifediol Extended-Release (ER) Capsule

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-10-08
• Completion: 2021-10-08
• First posted: 2020-09-16
• Last updated: 2024-05-28
• Results posted: 2024-05-28

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study