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.: PACTR202103601407640 Date of Approval: 24/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical trial, phase 3, to evaluate the efficacy of CVO + for the treatment of COVID-19.
Official scientific title Randomized clinical trial, phase 3, to evaluate the efficacy of CVO + versus placebo for the treatment of COVID-19.
Brief summary describing the background and objectives of the trial The overall objective of the study is to evaluate the clinical efficacy and safety of CVO + in comparison to the placebo arm in participants with COVID-19.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CNART21
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Treatment: Drugs
Anticipated trial start date 18/01/2021
Actual trial start date 18/01/2021
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 01/06/2021
Anticipated target sample size (number of participants) 338
Actual target sample size (number of participants) 339
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CVO plus 150 mg 3 times per day 15 days Artemisinin + cineol 169
Control Group Placebo 3 capsules per day 15 days capsules like intervention without active ingredients 169 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Study participant (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures. Agrees to the collection of OP swabs and venous blood per protocol. Male or non-pregnant female adult ≥18 years of age at time of enrolment. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR nasopharyngeal swab. Illness of any duration, and at least one of the follow ing: Clinical assessment (evidence of rales/crackles on exam) or Requiring mechanical ventilation and/or supplemental oxygen. Creatinine ≤ 110 umol/L, creatinine clearance rate (EGFR) ≥ 60 ml / min / 1.73m2, AST and ALT ≤ 5 × ULN, TBIL ≤ 2 × ULN; A Normal ECG Baseline result, which is maintained throughout the study. • ALT/AST > 5 times the upper limit of normal. • Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) • Pregnancy or breast feeding. • Anticipated transfer to another hospital w hich is not a study site w ithin 72 hours. • Allergy to any study medication • Shortness of breath in resting position • Known prolonged QT syndrome • Use of concomitant medications that prolong the QT/QTc interval • Participant with other viral pneumonia • Participants with allergies to artemisinin containing products • History of allergic reactions to any investigational medical product ingredient 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 17/12/2020 CERBM
Ethics Committee Address
Street address City Postal code Country
Tsaralalana Antananarivo 101 Madagascar
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome complete clearance of viral load or significant progressive reduction of the viral load in OP swabs on days 28 day 28
Secondary Outcome time to improvement, duration of stay at hospital, development of adverse or severe adverse events, changes (if any) on heart, liver, kidney and lung functions and complete blood count. D7, D14, D21, D28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CNARP Health center and VOARA Health Center RP Rahajarizafy Ambodivoanjo Antananarivo 101 Madagascar
FUNDING SOURCES
Name of source Street address City Postal code Country
PHARMALAGASY Zone forello Tanjombato Antananarivo 102 Madagascar
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PHARAMALAGASY Zone Forello Tanjombato Antananarivo 102 Madagascar Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
RAZAFINDRABE Falihery WHO Antananarivo 101 Madagascar
KAYOKO Gilbert WHO Antananarivo 101 Madagascar
NDAYE Charlotte WHO Antananarivo 101 Madagascar
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alson Olivat RAKOTO olivatrakoto@yahoo.fr +261341420215 HJRA
City Postal code Country Position/Affiliation
Antananarivo 101 Madagascar Hospital University Director
Role Name Email Phone Street address
Principal Investigator Rianasoambolanoro RAKOTOSAONA rravalison@gmail.com +261341169436 CNARP
City Postal code Country Position/Affiliation
Antananarivo 101 Madagascar Scientific Director of CNARP
Role Name Email Phone Street address
Public Enquiries Sedera Aurelien MIORAMALALA sedera.mioramalala@gmail.com +261341057733 CNARP
City Postal code Country Position/Affiliation
Antananarivo 101 Madagascar Data Manager CNARP
Role Name Email Phone Street address
Public Enquiries Dominique Razafimandimby domrazafimandimby9@gmail.com +261340500709 Military Hospital
City Postal code Country Position/Affiliation
Antananarivo 101 Madagascar Clinician
Role Name Email Phone Street address
Scientific Enquiries Arsene Ratsimbasoa aratsimbasoa@gmail.com +261340541965 CNARP
City Postal code Country Position/Affiliation
Antananarivo 101 Madagascar Scientist
Role Name Email Phone Street address
Scientific Enquiries Rivo Andry RAKOTOARIVELO rakotoarivelo.rivo@gmail.com +261341420149 CHU Tambohobe Fianarantsoa
City Postal code Country Position/Affiliation
Fianarantsoa 301 Madagascar Scientist
Role Name Email Phone Street address
Scientific Enquiries Fanomezantsoa Rakoto rakotofanomezantsoa@yahoo.fr +261321104960 Military Hospital
City Postal code Country Position/Affiliation
Antananarivo 101 Madagascar Scientist
Role Name Email Phone Street address
Scientific Enquiries Rabenja Rapelanoro frapelanoro@yahoo.fr +261320519476 University of Antananarivo
City Postal code Country Position/Affiliation
Antananarivo 101 Madagascar Scientist
Role Name Email Phone Street address
Scientific Enquiries Jhurry Dhanjay dhanjay.jhurry@gmail.com +23052523093 Moka Maritius
City Postal code Country Position/Affiliation
Mauritius 80832 Mauritius Vice Chancellor
Role Name Email Phone Street address
Scientific Enquiries Zely Randriamanantany zrandriamanantany@gmail.com +261343677308 CHU Tambohobe
City Postal code Country Position/Affiliation
Fianarantsoa 301 Madagascar Scientist
Role Name Email Phone Street address
Scientific Enquiries Fridolin Maminiaina maminiaina.olivier.fridolin@gmail.com +261341495072 IMVAVET Ampandrianomby
City Postal code Country Position/Affiliation
Antananarivo 101 Madagascar Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes geographic region, duration of symptoms prior to enrolment, age and sex, viral load, test results of biological, clinical information. Clinical Study Report 5 years principal investigator ; Data and Safety Monitoring Board
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