Sirolimus in COVID-19 Phase 1

NCT04371640 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 15680
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment

  SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR

  Baseline, and days 1, 2, 3, 4, 5, 6, & 7 post-dose for all patients

Secondary Outcomes (2)

• Change in SARS-CoV-2 viral burden at days 1-6

  Days 1, 2, 3, 4, 5, and 6 post-dose for all patients

• Rate of treatment emergent adverse events

  Days 1, 2, 3, 4, 5, and 6 post-dose for all patients

Study Arms (2)

Sirolimus

ACTIVE COMPARATOR

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

Drug: Sirolimus 1 MG/ML

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sirolimus 1 MG/ML DRUG

Oral solution

Also known as: Rapamune

Sirolimus

Placebo DRUG

Oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter K. Kraft: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Walter K Kraft, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: July 6, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)