Hydroxychloroquine/Azithromycin/Zinc Combination and Hydroxychloroquine/Lopinavir/Ritonavir/Azithromycin/Zinc combination versus the standard of care in The Treatment of Hospitalized COVID-19 Patients

ational Institute for Pharmaceutical Research and Development NIPRD0 sites210 target enrollmentJune 12, 2020

ConditionsCOVID 19

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: COVID 19
Sponsor: ational Institute for Pharmaceutical Research and Development NIPRD
Enrollment: 210
Status: Not yet recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

June 12, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ational Institute for Pharmaceutical Research and Development NIPRD

•. Hospitalized patients with PCR\- documented SARS\-CoV\-2 RNA from throat /nasopharyngeal swab, samples
•2\. Aged between 18\-80 years old
•3\. the weight is more than 30kg, and there is no limit for men and women
•4\. Patients who meet the following conditions: creatinine \= 110 umol / L, creatinine clearance rate (EGFR) \= 60 ml / min / 1\.73m2,
•5\. AST and ALT \= 5 × ULN
•6\. TBIL \= 2 × ULN;
•7\. Patients who are able to fully understand the purpose, nature, method of the study and the possible reactions to the study drugs, voluntarily participate in the study and sign the informed consent
•8\. Not having severe acute respiratory syndrome (SARS)
•9\. Patients not using mechanical ventilation or supplemental oxygen, with peripheral oxygen saturation \>94% in room air, and having a respiratory rate below 24 incursions per minute.
•6\. A Normal ECG Baseline result which remains same throughout the study.

•1\.Hypersensitivity reaction to chloroquine, 4\-aminoquinolines or azithromycin and ivermectin
•2\.Shortness of breath in resting position
•3\. Known prolonged QT syndrome
•4\. Active or clinically significant cardiac disease including congestive heart failure.
•5\. History or current evidence of clinically significant cardiac arrhythmia, atrial fibrillation or paroxysmal supraventricular tachycardia
•6\. Use of concomitant medications that prolong the QT/QTc interval
•7\. Elevated levels of troponin I, Creatinine kinase MB, and Myoglobin
•8\. Known glucose\-6\-phosphate dehydrogenase (G6PD) deficiency
•9\. Already receiving chloroquine or azithromycin
•10\. Patients with other viral pneumonia