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Trial - NCT04371640


Column Value
Trial registration number NCT04371640
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04371640

First author
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Walter K Kraft

Contact
Last imported at : Nov. 25, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Edwin Lam, edwin.lam@jefferson.edu (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-01

Recruitment status
Last imported at : Dec. 9, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Walter K. Kraft

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : Dec. 9, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1204, "treatment_name": "Sirolimus", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]