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Sirolimus in COVID-19 Phase 1

NCT ID: NCT04371640

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2021-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV-2 Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sirolimus

Sirolimus + standard medical care Day 1: 10mg Days 2-7: 5mg

Group Type ACTIVE_COMPARATOR

Sirolimus 1 MG/ML

Intervention Type DRUG

Oral solution

Placebo

Placebo + standard medical care Day 1: 10mL Days 2-7: 5mL

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution

Interventions

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Sirolimus 1 MG/ML

Oral solution

Intervention Type DRUG

Placebo

Oral solution

Intervention Type DRUG

Other Intervention Names

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Rapamune

Eligibility Criteria

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Inclusion Criteria

* Male or non-pregnant female \>/=18 and \</=65 years of age at the time of consent
* Laboratory confirmed SARS-CoV-2 infection
* Investigator-estimated hospitalization duration of at least 5 days

Exclusion Criteria

* Need for \>4 liters nasal cannula oxygen to maintain oxygen saturation \>90%
* Hypersensitivity to sirolimus
* Pregnant or breastfeeding
* Anticipated transfer to another study hospital within 72 hours
* Alanine transaminase (ALT) \>3 times the upper limit of normal
* Creatinine clearance \<30mL/min as estimated by Cockcroft-Gault
* Underlying immunosuppression due to daily \>5 mg prednisone equivalent a day, prior solid organ transplant, or other immunosuppression deemed by investigator to be potentially unsafe
* Co-administration with strong inhibitors of CYP3A4 and/or P-glycoprotein (P-gp) (such as ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin and others)
* Co-administration with strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) (such as phenytoin or rifampin)
* Anticipated surgery within 1 month
* Need for healing of a fracture or a significant soft tissue wound
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Walter K. Kraft

OTHER

Sponsor Role lead

Responsible Party

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Walter K. Kraft

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Walter K Kraft, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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15680

Identifier Type: -

Identifier Source: org_study_id