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.: PACTR202205508723236 Date of Approval: 30/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A multi-centre, placebo-controlled study of interferon beta-1a in high risk COVID- 19 outpatients (InterCoV)
Official scientific title A multi-centre, placebo-controlled study of interferon beta-1a in high risk COVID- 19 outpatients (InterCoV)
Brief summary describing the background and objectives of the trial The primary objective of this study is to see whether short-term intramuscular interferon beta-1a, administered early in the disease course, reduces the composite risk of the need for hospitalization (as measured by sats <92%, hospital or emergency department visits) or death in high-risk unvaccinated individuals with COVID-19. Secondary objectives include seeing whether interferon beta leads to a quicker viral clearance, or faster symptom resolution.
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 COVID-19
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/05/2022
Actual trial start date
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 2370
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes 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 Pegylated interferon beta1a 125 μg (0.5 ml) single dose Given intramuscularly 790
Experimental Group Nonpegylated interferon beta1a 30 μg (0.5 ml) Single dose Given intramuscularly 790
Control Group Placebo 0.5ml Single dose Given intramuscularly 790 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients who are capable and willing to provide informed consent. Confirmed COVID-19 infection (by rapid antigen test or PCR) within the past 72 hours COVID-19 symptoms, if present, must have commenced within 72 hours The patient has mild disease, as defined by: outpatient status – not currently hospitalized or under immediate consideration for hospitalization, oxygen saturation ≥ 92% on pulse oximeter (confirmed by two readings), respiratory rate <25 breaths / minute, heart rate < 120 beats / minute, mental status normal The patient has one or more risk factors for severe disease, specifically either: Age ≥40 years with one of the following comorbidities: Obesity (BMI ≥ 30 kg/m2), Diabetes (type 1 or 2), Chronic kidney disease, Chronic cardiovascular disease (previously diagnosed heart failure, coronary artery disease, cerebrovascular accident, or peripheral vascular disease), Chronic lung disease (asthma, chronic obstructive pulmonary disease, interstitial lung disease, active or previous pulmonary tuberculosis) OR Age ≥60 years irrespective of any comorbidities Patient must be able and willing to comply with the requirements of this study protocol. A history of anaphylaxis with interferon therapy A history of severe depression or suicidal ideation A history of epilepsy not adequately controlled by therapy Decompensated liver disease (cirrhosis or severe hepatic disease, or visible jaundice) Chronic kidney disease with a known or suspected creatinine clearance <30 ml/min. For women: pregnant, or breastfeeding, or is considering becoming pregnant during the study. Currently taking interferon for other indications. Patient is, in the opinion of the investigator, unable to accurately record their pulse oximetry readings. Participation in a COVID-19 clinical study involving an investigational agent within the preceding 30 days. The participant is considered 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) 150 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 23/05/2022 PharmaEthics
Ethics Committee Address
Street address City Postal code Country
123 Arcor Road Lyttlelon Manor 0157 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary endpoint will be the composite of: • hospitalization or emergency department visit within 30 days of randomization and/or • oxygen saturation <92% (as measured on study visit or at home by pulse oximetry by two consecutive readings) • death (by 30 days following randomization) 30 days post randomisation
Secondary Outcome • hospitalization or emergency department visit within 30 days of randomization • oxygen saturation <92% (as measured on study visit or at home by pulse oximetry, and confirmed by immediate repeat testing) • death within 30 days of randomization • time (in days) to either negative SARS-CoV-2 RT-PCR, or a positive RT-PCR with a cycle threshold >30 [whichever is first] • time (in days as per the patient diary or study visit) to become asymptomatic • time (in days as per the patient diary or study visit) to have a ≥1 point improvement on the WHO ordinal COVID-19 symptom scale [see appendix 1 for scale] 30 days post randomisation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
About Allergy 841 Lavender Road Pretoria 0009 South Africa
Progress Clinical Trial Research Unit Suit 10 Zandspruit Value Centre Johannesburg 2040 South Africa
Health Emporium Midrand Medical Centre, Shop 1 Midrand 1685 South Africa
The Aurum Institute Rustenburg Clinical Research Centre, 50 Steen Street Rustenburg 0299 South Africa
Merc Welkom 189 Power Road Welkom 9460 South Africa
Merc Research Kempton Park Shop 531A, Kepton Square Kempton Park 1619 South Africa
Merc Middelburg 184 Cowen Ntuli Street Middleburg 1055 South Africa
Ndlovu Research Centre Plot 1140 Dennilton Dennilton 0470 South Africa
Josha Research 28 East Burger Street Bloemfontein 9301 South Africa
Synergy Biomed 280 Oxforf Street East London 5201 South Africa
FCRN Clinical Centre 107 General Hertzog Road Vereeniging 1935 South Africa
Setshaba Research Center 2088 Block H Soshanguve 0152 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation Grant INV 037511 500 Fifth Ave. N. Seattle WA 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand Vaccines and Infectious Diseases Analytics 30 Chris Hani Road Soweto 1862 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jeremy Nel jeremy.nel@wits.ac.za +27722775001 1 Perth Road
City Postal code Country Position/Affiliation
Johannesburg 2092 South Africa Infectious Diseases Specialist
Role Name Email Phone Street address
Scientific Enquiries Shabir Madhi Shabir.Madhi@wits.ac.za +27119834283 30 Chris Hani Road
City Postal code Country Position/Affiliation
Soweto 1862 South Africa Wits WIDA Executive Director
Role Name Email Phone Street address
Public Enquiries Catherine Hill Catherine.Hill@wits-vida.org +27119834283 30 Chris Hani Road
City Postal code Country Position/Affiliation
Soweto 1862 South Africa Wits VIDA CEO
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual patient data will be shared with the sponsor, regulatory agencies, and researchers who provide a methodologically sound proposal. Informed Consent Form,Study Protocol 30 calendar days after primary completion date Sponsor review, regulatory assistance, or any good faith research-related endeavour.
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