COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23709

Catherine Hill

Catherine.Hill@wits-vida.org

2022-05-09

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

3

University of the Witwatersrand Vaccines and Infectious Diseases Analytics

18

100

South Africa

Mild disease at enrollment

1: Mild disease at enrollment

2370

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

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 671, "treatment_name": "Interferon beta 1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 965, "treatment_name": "Peginterferon beta-1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]