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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202880140319 Date of Approval: 09/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ibuprofen in COVID19
Official scientific title Early use of ibuprofen in COVID-19 might a promising agent to attenuate the severity of the disease: A randomized controlled trial
Brief summary describing the background and objectives of the trial The pathogenesis of Coronavirus disease 2019 (COVID-19) is still not completely understood , COVID 19 do trigger life-threatening “cytokine storms” in the host which can result in significant pathology and ultimately death, ibuprofen (non-steroidal anti-inflammatory drugs (NSAIDs) might prove beneficial for the early management of COVID-19 trying to antagonist inflammatory process
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied COVID 19
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/01/2022
Actual trial start date 26/02/2022
Anticipated date of last follow up 05/02/2022
Actual Last follow-up date 09/07/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL https://scholar.google.com/citations?user=vcn8u0sAAAAJ&hl=en http://research.asu.edu.eg/mydspace
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group CONTROL GROUP Paracetamol dose in control group groups will be 500 mg/6h 4 DAYS standard protocol for treatment covid patients using paracetamol 50 Active-Treatment of Control Group
Experimental Group IBUPROFEN GROUP Ibuprofen in ibuprofen group will be 400 mg/6h 4 DAYS standard protocol for treatment covid patients using ibuprofen 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age: 18 - 60 years-old both sex 2. moderate case covid 19 diseases 1- Severe case covid disease. 2. Advanced liver disease. 3- Renal dysfunction. 4- History of peptic ulcer. 5. History of allergy to ibuprofen or paracetamol. 6. Vaccinated patient by any type of vaccine either single or twice dose Adult: 19 Year-44 Year,Aged: 65+ Year(s) 18 Year(s) 60 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 20/01/2022 Research ethical committee at faculty of medicine Ain shams university Federal Wide Assurance FWA000017585
Ethics Committee Address
Street address City Postal code Country
Faulty of medicine, Ain Shams University, Abbasia ,cairo cairo 11561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The number of patient improved and discharge to home WITHIN 3-5 DAYS
Secondary Outcome 1- number of patient transfer to ICU 2 number of patient need oxygen supply to maintain oxygen saturation above 92%. 3. The intermediate unit duration of stay 4 DAYS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospitals 38 Abbasia squre- cairo-egypt cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amr Sobhy 9 elfda-naser city cairo 11759 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ain shams university abassia cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed kamal 9 elfda naser city cairo 11759 Egypt
Lobna ahmed saleh elnozha cairo 11843 Egypt
Marwa Esmail AbdelAtty naser city cairo 11759 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AMR SOBHY dr.amrsobhy2013@gmail.com 00201063394383 7 elmakwleen elarab
City Postal code Country Position/Affiliation
cairo 11843 Egypt associated professor Ain shams university
Role Name Email Phone Street address
Public Enquiries LOBNA SALEH lobnasaleh_80@yahoo.com 00201005246397 naser city
City Postal code Country Position/Affiliation
cairo 11759 Egypt lecturer Ain shams university
Role Name Email Phone Street address
Scientific Enquiries bahaa ewis bahaaew@yahoo.com 00201222406018 nasr city
City Postal code Country Position/Affiliation
cairo 11759 Egypt professor Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Excel Sheet Statistical Analysis Plan within 12 months Editors of journal to be submitted to
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available yet No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information