NCT04371640

Sirolimus in COVID-19 Phase 1

A Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Virological Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sirolimus Adjuvant Therapy in Patients With Coronavirus Disease (COVID-19)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Walter K. Kraft · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blinded, two-arm, randomized, placebo controlled study comparing the virological efficacy of add-on sirolimus with standard care to placebo and standard care. Virological efficacy is defined as the change from baseline to day 7 in SARS-CoV-2 viral burden measured by quantitative real-time polymerase chain reaction.

Conditions

• SARS-CoV-2
• Covid-19

Interventions

Type	Name	Description
DRUG	Sirolimus 1 MG/ML	Oral solution
DRUG	Placebo	Oral solution

Timeline

• Start date: 2020-07-06
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2020-05-01
• Last updated: 2021-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study