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.: PACTR202010690466874 Date of Registration: 07/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title KNUST COVID-19 CLINICAL TRIAL
Official scientific title Repurposing the aqueous extract of cryptolepis for COVID-19 immunotherapy
Brief summary describing the background and objectives of the trial Summary of trial concept protocol of the proposed KNUST Covid-19 clinical trial The coronavirus disease 2019 (COVID-19) was declared a global pandemic by the World Health Organization (WHO) in March 2020 and has since infected more than 30 million people and claimed the lives of over 1 million people as of October 1, 2020. Currently, there is no approved vaccine and also no treatment for COVID-19. In line with the WHO SOLIDARITY trial, the current proposed work would investigate the potential COVID-19 treatments using Ghana’s FDA approved antimalarial Cryptolepis sanguinolenta-based (Nibima). From the first months of the COVID-19 pandemic, scientists baffled by the disease's ferocity have wondered whether the body's vanguard virus fighter, a molecular messenger called type I interferon, is missing in action in some severe cases. Two papers published online in Science this week confirm that suspicion. They reveal that in a significant minority of patients with serious COVID-19, the interferon response has been crippled by genetic flaws or by rogue antibodies that attack interferon itself (DOI: 10.1126/science.369.6511.1550). Nibima was selected because our preliminary results showed it augmented interferon production in human immune cells. The interferon response pathway (IFN-1) is a first-line immune defence system that limits or eliminates viral infections. Nibima is also reported as anti-inflammatory agent that could stop the deadly ‘cytokine storm’ caused by SARS-Cov-2. The current proposed pilot study would test the hypothesis that Nibima would effectively reduce SARS-Cov-2 viral load and improve clinical recovery rates of more than 50%. Therefore, our primary objectives are: (1) To evaluate the efficacy of Nibima in reducing >50% SARS-Cov-2 viral load per patient within 14 days of therapy and (2) to evaluate the efficacy of Nibima in increasing the anti-inflammatory and interferon alpha/beta profiles of >50% of the Covid-19 patients within 14 days We aim to conduct a phase 2 randomized controlled Open-label clinical trial with the current approved Nibima dosage to repurpose for Covid-19 positive patients. The patients would enrolled based on specific inclusion and exclusion criteria, categorized into moderate and severe ARDS and the treatment started immediately after baseline clinical and laboratory assessments see attached work flow diagram and scheduled activities.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KNC19
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVD-19
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2020
Actual trial start date 01/12/2020
Anticipated date of last follow up 20/12/2020
Actual Last follow-up date 29/01/2021
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nibima 30ml three times daily 14 days Aqueous extract of cryptolepis sanguinolenta 10
Control Group Drinking water 30 mls three times daily 14 days Portable drinking water. 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, aged 18 or above. Covid-19 laboratory confirmed. Ability to take oral medication and be willing to adhere to the study inter-vention regimen. Presence of <specific devices (e.g., cardiac pacemaker). Pregnancy or lactation. Known allergic reactions to components of the study intervention (C. san-guinolenta). Treatment with another investigational drug other than the current Covid-19 standard therapy. Treatment with herbal medicine in the past 4 weeks. Current smoker. Mentally unstable Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 15/09/2020 Committee on human research publication and ethics
Ethics Committee Address
Street address City Postal code Country
J W Achaempong Close Kumasi AK3848028 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Covid-19 viral load/patient reduced by >50% over a period of 14 days. 2. Improvements in Covid-19 clinical recovery rate by 50% over a period of 14 days. Primary
Secondary Outcome Study intervention will effectively and safely progress and there will be no need to prematurely stop the study. Secondary
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kumasi South Hospital Lake Road Kumasi AK 440 83 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Kwame Nkrumah University of Science and Technology University Post Office Kumasi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kwame Nkrumah University of Science and Technology PMB University Post Office Kumasi Ghana University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mutocheluh mutocheluh@gmail.com 00233200504700 J W Acheapong Close
City Postal code Country Position/Affiliation
Kumasi Ghana Associate Professor
Role Name Email Phone Street address
Principal Investigator Ellis Owusu Dabo owusudabo@yahoo.com 00233201964425 J W Achaepong Close
City Postal code Country Position/Affiliation
Kumasi Ghana Professor
Role Name Email Phone Street address
Public Enquiries Mohamed Mutocheluh mutocheluh@gmail.com 00233200504700 J W Achaempong Close
City Postal code Country Position/Affiliation
Kumasi Ghana Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be shared within 6 months of study completion. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD Sharing time frame is 12 months. This is a very small COVID-19 pilot study and so the data generated would be open to any interested party upon official request in writing.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available 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