Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT04428268
Status:
WITHDRAWN
Last Update Posted:
2021-02-18
First Post:
2020-04-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia
Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Organization:
Study Overview
Official Title:
Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Chloroquine + Low Dose Losartan Compared to Chloroquine Monotherapy in Subjects With SARS-CoV-2 Pneumonia
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
evidence showed chloroquine is not effective against COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study design Phase 2, double blinded, single-center, 1:1 randomized clinical trial of Chloroquine vs Chloroquine/losartan for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects
Detailed Description:
Study design Phase 2, blinded, single-center, 1: 1 randomized clinical trial for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects. Two of the co-investigators and the data analyst will remain blind to group allocation until after statistical analysis.
The groups will consist of subjects receiving in one arm PO Chloroquine 450mg every 12 hours and in the other arm, in addition to chloroquine, PO Losartan 25mg every 24 hours. Study drugs will be administered for a total of 10 days enterally.
Baseline demographics and clinical characteristics will be registered and periodically during the study.
nasopharyngeal swabs will be taken every 48hrs during hospitalization to determine the presences and viral load of SARS-CoV-2, and daily EKG for QT interval monitoring.
The groups will consist of subjects receiving in one arm PO Chloroquine 450mg every 12 hours and in the other arm, in addition to chloroquine, PO Losartan 25mg every 24 hours. Study drugs will be administered for a total of 10 days enterally.
Baseline demographics and clinical characteristics will be registered and periodically during the study.
nasopharyngeal swabs will be taken every 48hrs during hospitalization to determine the presences and viral load of SARS-CoV-2, and daily EKG for QT interval monitoring.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: