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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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18 May 2020 |
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Main ID: |
IRCT20200411047025N1 |
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Date of registration:
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2020-04-14 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Intravenous vitamin c in Patients with COVID-19
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Scientific title:
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Evaluation of effectiveness? of Intravenous vitamin c in Patients with COVID-19 Referred to Imam ?Khomeini Hospital: a clinical trial ? |
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Date of first enrolment:
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2020-04-18 |
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Target sample size:
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110 |
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Recruitment status: |
Recruiting |
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URL:
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http://en.irct.ir/trial/47078 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. In this study we will be considered 4 patients in a block.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Fereshteh Ghiasvand
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Address:
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Keshavarz Blvd?
1419733141
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 6119 2811 |
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Email:
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Ghiasvand_62@yahoo.com |
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Affiliation:
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Tehran University of Medical Sciences |
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Name:
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Fereshteh Ghiasvand
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Address:
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Keshavarz Blvd?
1419733141
Tehran
Iran (Islamic Republic of) |
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Telephone:
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009861192811 |
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Email:
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ghiasvand_62@yahoo.com |
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Affiliation:
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Tehran University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: At least 18 years old
The case of definite or probable of covid-19
Exclusion criteria: The patient with chronic renal failure or dialysis
The patient withG6PD deficiency
Age minimum:
18 years
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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covid-19.
COVID-19, virus identified
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U07.1
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Intervention(s)
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Intervention 1: Intervention group: case group 55 patients treat with intravenous vitamin c 1.5 gram 4 times a day and Hydroxychloroquine ??400 mg in the ?first day and then 200 mg BID plus Atazanavir / Ritonavir 300/100? daily 5 days. Every vitamin c vial content of 500 mg and is from Darou Pakhsh factory. The patients receive 3 vials slow infusion (1-2 hours) with normalsaline. Duration of treatment base of clinical response is 3-5 days. Renal function with BUN and CR monitor every other day. Intervention 2: Control group: control group 55 patients treat with Hydroxychloroquine ??400 mg in the ?first day and then 200 mg BID plus Atazanavir / Ritonavir 300/100? daily 5 days.
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Primary Outcome(s)
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Improvement of SPO2 (stands for peripheral capillary oxygen saturation). Timepoint: Daily, until 3-5 days or discharge. Method of measurement: pulse oximetry.
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Secondary Outcome(s)
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Creatinine. Timepoint: every other day until discharge. Method of measurement: Laboratory test.
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Respiratory rate. Timepoint: 4 times a day until 3-5 days or discharge. Method of measurement: physical examination.
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Lymphocytosis. Timepoint: every other day until discharge. Method of measurement: laboratory test.
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CRP. Timepoint: Every other day until discharge. Method of measurement: Laboratory test.
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Fever subside. Timepoint: 4 times a day until 3-5 days or discharge. Method of measurement: termometer.
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Source(s) of Monetary Support
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Research Assistant of Tehran University of Medical Sciences
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Ethics review
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Status: Approved
Approval date: 30/03/2020
Contact:
Ethics committee of Tehran University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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