COVID-19
Conditions
Interventions
Pegylated interferon beta1a
Nonpegylated interferon beta1a
Placebo
Sponsors
University of the Witwatersrand Vaccines and Infectious Diseases Analytics
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| • hospitalization or emergency department visit within 30 days of randomization • oxygen saturation 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] | — |
Countries
South Africa
Contacts
Public ContactCatherine Hill
Wits VIDA CEO
Outcome results
None listed