Protocol summary
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Study aim
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Evaluating efficacy and safety of Hydroxychloroquine + Lopinavir or Atazanavir/ritonavir combination in patients with COVID-19
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Design
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This is a non-blinded, single group clinical trial.
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Settings and conduct
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Following data will be collected from admitted patients to Imam Khomeini hospital complex (according to the type of data at admission, daily or every other day)
Chief complaint at admission
Vital singes
Baseline diseases
History of drug use
History of vaccination
Hemodynamic parameters
Oxygenation parameters
Laboratory data
Respiratory support requirement
Supportive care
Drug therapy
Adverse drug reactions
Duration of hospitalization
Complications during hospitalization
Clinical outcome
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with highly suspected or confirmed COVID-19 who are candidate for hospitalization and starting triple-drug therapy
Exclusion criteria: History of drug allergy, pregnancy and lactation
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Intervention groups
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Patients will receive 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.
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Main outcome variables
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Clinical response
Laboratory response
Incidence rate of adverse drug reactions
General information
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Reason for update
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Edition of the interventions due to changes in the national protocol
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100228003449N30
Registration date:
2020-03-22, 1399/01/03
Registration timing:
registered_while_recruiting
Last update:
2020-03-24, 1399/01/05
Update count:
1
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Registration date
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2020-03-22, 1399/01/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-15, 1398/12/25
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Expected recruitment end date
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2020-05-14, 1399/02/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating efficacy and safety of hydroxychloroquine + lopinavir or atazanavir/ritonavir combination in patients with COVID-19
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Public title
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Combination therapy in COVID 19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with highly suspected or confirmed COVID-19 who are candid for hospitalization and starting triple-drug combination
Exclusion criteria:
History of drug allergy
Pregnancy
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Age
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No age limit
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-15, 1398/12/25
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.1058
Health conditions studied
1
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Description of health condition studied
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COVID-19 pneumonia
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Clinical response
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Timepoint
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Every other day
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Method of measurement
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Evaluation of clinical signs and symptoms
2
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Description
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Paraclinical response
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Timepoint
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Every other day
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Method of measurement
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Laboratory and radiological findings
3
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Description
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Adverse drug reactions
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Timepoint
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Every other day
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Method of measurement
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Interview and laboratory data
Secondary outcomes
1
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Description
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Duration of hospitalization
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Timepoint
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End of hospitalization
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Method of measurement
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Medical records
2
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Description
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Clinical outcome
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Timepoint
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End of study
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Method of measurement
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Patient's record
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript
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When the data will become available and for how long
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One year after finishing the study, data will be published and will be available in databases
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To whom data/document is available
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After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes
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Under which criteria data/document could be used
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Other researchers are permitted to included the results in their systematic reviews and metaanalysis
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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
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Comments
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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