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.: PACTR202101875903773 Date of Approval: 25/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A novel drug combination and route for COVID-19 treatment
Official scientific title The use of topical (Nasal and oropharyngeal) Povidone iodine plus topical Glycyrrhizic acid and oral Glycyrrhizic acid syrup for prevention and treatment of early COVID-19 cases.
Brief summary describing the background and objectives of the trial Covid-19 pandemic is considered a huge health and economic problem affecting all the world population. The current treatment protocol uses either a systemic antiviral, immunostimulants or vaccines .the course of COVID-19 disease can be stratified into two distinctive phases. Phase 1, that corresponds to the incubation period and the early symptomatic phase wherein the virus still resides the naso-pharynx and oropharynx , and stage two in which the virus invades the lower respiratory tract. In the present protocol we provide a novel multimodal safe approach to protect and treat phase 1 cases of COVID-19 invasion and to prevent further spread of infection. This approach entails the use of a combination of topical and systemic new antivirals that have been proven to fight, attenuate and kill Corona virus.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Corona virus
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/01/2021
Actual trial start date 15/03/2021
Anticipated date of last follow up 01/07/2021
Actual Last follow-up date 01/07/2021
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 Permuted block randomization Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Povidone Iodine plus Glycyhrrizic acid nasopharyngeal spray plus Glycyrrhizic acid syrup every 6 hours One week The drug spray will be used via nasal and oropharyngeal route 4 times per day for early diagnosed PCR positive cases of corona virus plus GA syrup 4 times per day to give a total GA dose of 400 mg per day for patient in the treatment group plus the conventional approved treatment protocol of Corona virus in the hospital. 100
Control Group Positive control group four times per day One week Placebo spray plus placebo syrup will be used in addition to the conventional protocol for corona virus cases. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
COVID-19 PCR positive patients of both genders aging 6 to 70 years having no symptoms or early symptoms such as loss of taste and smell, fever, cough with good O2 saturation. Patients with CT evidence category 4 or 5. Patients with dropped O2 saturation below 90 on room air. Patients with uncontrolled hypertension or diabetes mellitus. Ventilated patients or those with multiorgan failure. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 6 Year(s) 70 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 21/01/2021 Fever and Liver hospital
Ethics Committee Address
Street address City Postal code Country
Meet Khalaf Shebin Alkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be the PCR result for corona virus on day 4 and day 10. This will be done for the early treatment experiment day 4 and day 10
Secondary Outcome The post-treatment day that the fever subsides day 2, day 3, day 4, day 5
Secondary Outcome the post-treatment day for return of taste and smell day 2, day3, day4, day5, day 10
Secondary Outcome The post-treatment day that the cough subsides day 2,day3, day 4, day, day5.
Secondary Outcome Number of patients needed hospitalization. at any time point
Secondary Outcome the number of deaths in both groups at any time point
Primary Outcome number of treated close contacts getting infected with corona virus in both groups from day 1 to day 15 of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
fever and liver hospital Meet Khalaf Shebin Alkom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Elsersy Hazem Ezzat Zaki Shabanah Street, Alzanaty tower, floor 7 Shebin Alkom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hazem Elsersy Zaki shabanah street, Alzanaty tower, 7th floor Shebin Alkom Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr abdulazeem Albakry Alezba Algarbia Shebin Alkom Egypt
Dr. Magdy Zahran Nasr city Cairo Egypt
Dr. Ihab Kamal New Cairo Cairo Egypt
Dr. Hussain Mohammed Meet Khalaf Shebin Alkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hazem Elsersy hazelsersy@hotmail.com 00201091096655 Zaki Shabanah Street
City Postal code Country Position/Affiliation
Shebin Alkom Egypt A Professor of ICU and anaesthesia faculty of medicine Menoufia university
Role Name Email Phone Street address
Public Enquiries Dr. Magdy Zahran magdyzahran@gmail.com 00201007208275 Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Professor of organic chemistry Faculty of science Menofia University.
Role Name Email Phone Street address
Scientific Enquiries Hazem Elsersy hazelsersy@hotmail.com 00201091096655 Zaki Shabanah Street
City Postal code Country Position/Affiliation
Shebin Alkom Egypt A Professor of ICU and aneasthesia Faculty of medicine Menoufia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All The individual patient data collected during the trial, after deidentification will be shared. Study Protocol Beginning 9 months and ending 36 months following article publication . Proposal should be directed to hazelsersy@hotmail.com to gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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