]>
IRCT20100228003449N30 IRCT 2020-03-22 Tehran University of Medical Sciences Combination therapy in COVID 19 Evaluating efficacy and safety of hydroxychloroquine + lopinavir or atazanavir/ritonavir combination in patients with COVID-19 2020-03-15 anticipated 50 Complete https://irct.ir/trial/46536 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 COVID-19 pneumonia. Intervention group: Patients in this group will receive drug regimen including Tab hydroxychloroquine 400 mg twice daily on day 1 then 200 mg twice daily + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily for at least 5 days.. Yes - There is a plan to make this available What will be shared: Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript When: One year after finishing the study, data will be published and will be available in databases To whom: After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes Conditions: Other researchers are permitted to included the results in their systematic reviews and metaanalysis Where to obtain: For this you may ask Hossein Khalili through following information: Address: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave.,Tehran, Iran Postal code: 1417614411 E-mail: khalilih@tums.ac.ir How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks Comments: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks
public Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4715 khalilih@tums.ac.ir Tehran University of Medical Sciences scientific Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4715 khalilih@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with highly suspected or confirmed COVID-19 who are candid for hospitalization and starting triple-drug combination no limit no limit Both History of drug allergy Pregnancy Treatment - Drugs Intervention group: Patients in this group will receive drug regimen including Tab hydroxychloroquine 400 mg twice daily on day 1 then 200 mg twice daily + Tab lopinavir/ritonavir 200/50 mg two tablets twice daily or Tab atazanavir/ritonavir 300/100 mg daily for at least 5 days. Clinical response. Timepoint: Every other day. Method of measurement: Evaluation of clinical signs and symptoms. Paraclinical response. Timepoint: Every other day. Method of measurement: Laboratory and radiological findings. Adverse drug reactions. Timepoint: Every other day. Method of measurement: Interview and laboratory data. Duration of hospitalization. Timepoint: End of hospitalization. Method of measurement: Medical records. Clinical outcome. Timepoint: End of study. Method of measurement: Patient's record. Tehran University of Medical Sciences Approved 2020-03-15 Ethics Committee of Tehran University Of Medical Sciences Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)