Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202406512501178 Date of Registration: 06/06/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Quercetin as an antiviral agent against Coronavirus infection: Double blind clinical trial
Official scientific title Quercetin supplementation and covid 19 evolution: a randomized clinical trial in hospitalized patients
Brief summary describing the background and objectives of the trial Many previous clinical studies have indicated that Quercetin has fulfilled pharmacological activities.Indeed, this herbal remedies have anti-oxidant, anti-inflammatory and anti-allergy properties and it has been used to treat many viral disease. In 2020, Covid-19 has rapidly spread in many geographical areas as a cluster of pneumonia that caused an acute respiratory syndrome coronavirus 2 (SARS CoV-2) . Since the pathophysiological mechanism of coronavirus is based mainly on a cytokine storm, inflammation and oxidation, quercetin, thanks to its broad effects, seems beneficial as a phytotherapy, in the treatment of SARS CoV-2 damage. In our study, the objective was to evaluate the effect of quercetin in the prevention and treatment of serious complications caused by to covid-19.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2021
Actual trial start date 01/05/2021
Anticipated date of last follow up 30/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 244
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group treated group 800 mg quercetin/day (400 mg twice a day) and then 400 mg daily 800 mg quercetin/day (400 mg twice a day)for 10 days and then 400 mg daily for a month post-intervention The allocation of the patients in the two groups was made using the table of random numbers and resumed in a table containing the allocation of each patient. Sealed envelopes containing one of the compared treatments were prepared in advance by the investigator for each patient.Thus, the patient and the attending physician were unaware of the treatment administered. Only the investigator was aware of the nature of the treatment administrated. 122
Control Group untreated group The patients allocated to the placebo group received placebo daily ( one tablet twice a day then one tablet / day). Placebo supplements were prepared exactly the same way minus the quercetin one tablet twice/day for 10 days then one tablet/day for a month post-intervention The allocation of the patients in the two groups was made using the table of random numbers and resumed in a table containing the allocation of each patient. Sealed envelopes containing one of the compared treatments were prepared in advance by the investigator for each patient.Thus, the patient and the attending physician were unaware of the treatment administered. Only the investigator was aware of the nature of the treatment administrated. 122 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
male or female >20 years of age and SARS COV2 positif hospitalizes subjects pregnant women or lactating and non hospitalized subjects 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/04/2021 ethics committee of the university hospital of Gabes under the auspices of medecine faculty of Sfax
Ethics Committee Address
Street address City Postal code Country
ibn khaldoun street, Gabes, Tunisia Sfax 3011 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the reduction in complications and mortality releatedto the disease after one month post-intervention
Secondary Outcome the reduction in the duration of hospitalization after hospital discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mohamed Ben Sassi university hospital Gabes Tunisia Rue ibn khaldoun Gabes Tunisia Gabes 6014 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
HDC laboratory Gabes Tunisia Gabes 6014 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor HDC laboratory Gabes, Tunisia Gabes 6014 Tunisia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator marwa gargouri marwagargouri.infectieux@gmail.com 21658981335 Gabes, Tunisia
City Postal code Country Position/Affiliation
Gabes 6014 Tunisia university hospital assistant
Role Name Email Phone Street address
Public Enquiries jihen jdidi jdiditrabelsijihen@glmail.com 21651061561 teniour street
City Postal code Country Position/Affiliation
sfax 3041 Tunisia hospital university professor
Role Name Email Phone Street address
Scientific Enquiries hela gargouri hela.gargouri@usf.tn 21622364141 sakiet eddair
City Postal code Country Position/Affiliation
sfax 3011 Tunisia engineer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol, Statistical analysis plan, analytic code will be avialable beginning 3 months and ending 5 years following article publication. IPD sharing statement: the resarch team will share individual participant data that inderlie the results reported in this article after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol beginning 3 months and ending 5 years following article publication Proposal should be directed to marwa_gargouri@medecinesafx.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 04/03/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/04/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information