Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04374903
Status:
WITHDRAWN
Last Update Posted:
2022-05-27
First Post:
2020-05-03
Brief Title:
Hydroxychloroquine in Combination With Sirolimus and Dexamethasone for Treating COVID-19 Patients
Sponsor:
King Hussein Cancer Center
Organization:
King Hussein Cancer Center
Study Overview
Official Title:
Hydroxychloroquine in Combination With Sirolimus and Dexamethasone for Treating COVID-19 PatiEnts A Pilot Multicenter Randomized Open-Label Trial
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study could not be implemented at the site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID19-HOPE
Brief Summary:
COVID-19 caused an unprecedented international crisis There is an urgent need for an effective regimen to cure this illness Anecdotal data and some prospective results suggested a role of antimalarial drugs chloroquine and hydroxychloroquine in the treatment of this disease with best available data showing value of adding azithromycin Based on drug repurposing studies done by our team and others we identified the autophagyapoptosis pathway as a major target for intervention Based on in-silico and in-vitro models sirolimus was identified as the drug that deserves urgent prioritization The rational for combining sirolimus and hydroxychloroquine is explained in details in the study background below and a short video prepared by study PI httpsyoutube-zlOMXJp2hg The evidence for using sirolimus for influenza is emphasized by a RCT that showed reduction of mechanical ventilation time by 50 7 days on sirolimus arm vs 15 days on oseltamivirsteroids arm Safe administration in human subjects is illustrated by multiple phase III clinical trials performed in patients with cancer COVID19-HOPE trial will randomize patients to 2 arms HCQAZ Arm A and HCQSIR Arm B The main inclusion criteria is an RT-PCR test confirming infection with SARS-CoV-2 along with objective clinical criteria of disease fever tachypnea andor hypoxemia The primary endpoint of study will be Time To Clinical Improvement TTCI defined as time from randomization to resolution of the clinical features mentioned above no fever no tachypnea and no hypoxemia In addition secondary endpoints will include clinical failure by day 28 need for intubation andor death QT interval prolongation and adverse events The estimated NNT based on Wilcoxon Mann Whitney comparison of TTCI in study arms is 58 patients 29 each arm The study includes an adaptive plan meaning that after different time points the study results will be evaluated and the NNT and randomization scheme 11 vs others will be evaluated and submitted to the IRB Also if one arm proves to be of no value another regimen might be introduced based on available data The study will recruit patients for a year and once approved by IRB and JFDA attempts to recruit other centers will be made including national and regional centers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None