A multi-centre, placebo-controlled studyof interferon beta-1a in high risk COVID-19 outpatients (InterCoV)

Phase 3

• Conditions: COVID-19

• Registration Number: PACTR202205508723236
• Lead Sponsor: niversity of the Witwatersrand Vaccines and Infectious Diseases Analytics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 2370

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the composite of:<br>• hospitalization or emergency department visit within 30 days of randomization<br>and/or<br>• oxygen saturation <92% (as measured on study visit or at home by pulse oximetry<br>by two consecutive readings)<br>• death (by 30 days following randomization)

Secondary Outcome Measures

Name	Time	Method
• hospitalization or emergency department visit within 30 days of randomization<br>• oxygen saturation <92% (as measured on study visit or at home by pulse oximetry,<br>and confirmed by immediate repeat testing)<br>• death within 30 days of randomization<br>• time (in days) to either negative SARS-CoV-2 RT-PCR, or a positive RT-PCR with a<br>cycle threshold >30 [whichever is first]<br>• time (in days as per the patient diary or study visit) to become asymptomatic<br>• time (in days as per the patient diary or study visit) to have a =1 point improvement<br>on the WHO ordinal COVID-19 symptom scale [see appendix 1 for scale]